Quality Jobs

Jobs - Julie Bukar - Founder - JGB BioPharma Consulting Inc

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1) QA Representative – 7 month contract (Missouri) 983

2) Manager / Sr. Manager, Quality Systems and Document Control – Full Time Position (San Francisco Bay Area) L56GS

3) Compliance Manager – 6 month contract (Pennsylvania) 123

4) Sr. Manager, Quality Assurance Commercial Product – Full Time Position (San Francisco Bay Area) PB56G

5) (Associate) Director Quality Assurance (Full time position; San Francisco Bay area) X55SS

6) Sr Document Control Specialist – Full time position Or Contract if preferred (San Francisco Bay Area) U54SH

7) Regulatory/ QA Consultant (San Francisco Bay Area) F67VG

8) QA/Regulatory Document Control Consultant (San Francisco Bay Area) Q67TL

9) Global Senior Quality Risk Specialist – Full Time Position (San Francisco Bay Area) G62SY

10) Manager, Document Control – Full Time Position (San Francisco Bay Area) JH54D

11) Sr Document Control Specialist – Full Time Position (San Francisco Bay Area) V55SS

12) GCP Inspection Specialist – Full Time Position (San Francisco Bay Area) S62BG

‘) Manager / Sr. Manager GLP QA – Full Time Position (San Francisco Bay Area) S56GJ

1) QA Representative – 7 month contract (Missouri) 983

DESCRIPTION:

Inspect finished product.
Perform inspection and ensure proper disposition on incoming bulk drug products and packaging materials.
Inspect packaging area before, during, and after operation.
Perform verification of room and equipment cleaning and maintain logs as required by Sop’s.
Additional duties as assigned.

EXPERIENCE AND QUALIFICATIONS:

Practical knowledge of FDA’s current Good Manufacturing Practices (cGMP).
Must be able to read, interpret and execute requirements of standards such as ANSI/ASQ Z1.4.
Read and understand Standard Operating Procedures, Master Production Control Documents, Component Specifications, safety guidelines and company policies.
Mathematical ability and computer skills including Microsoft Word, Excel and Outlook.
Ability to write clearly and concisely.
Provide accurate oral and written technical communications/direction.
Must be able to work independently, prioritize and exhibit attention to details.
Able to transport or move objects up to 35 pounds.
High school education or equivalent.
Prefer a minimum six months to one year of Quality Assurance experience.

To apply for a position send your resume to Jobs@JGBBioPharma.com

2) Manager / Sr. Manager, Quality Systems and Document Control – Full Time Position (San Francisco Bay Area) L56GS

DESCRIPTION:

This position is responsible for maintaining and improving quality systems that support and ensure GXP compliance in both a development and commercial environment. Manage and improve the document control and document archive functions, change control, training systems, vendor management, metrics reporting, and CAPA systems. Collaborate with other members of the Quality organization to assure that all site QA functions are performed; management is informed of significant compliance issues; quality systems and services are provided for on-site and contractors as appropriate.
At the senior manager level, the incumbent in this position will establish operational objectives and assignments and may delegate assignments to subordinate staff as well as be involved in recommending policy changes and executing company policies that may affect immediate operations(s).
This position will work on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. Ensures budgets, schedules and performance requirements are met. Erroneous decisions may result in critical delay(s) in schedules and/or unit operations and may jeopardize overall business activities.
At the senior manager level, this position regularly interacts with senior management or executive levels on matters concerning functional and/or project activities. Requires the ability to change the thinking of or gain acceptance of others in sensitive situations.

MAJOR DUTIES OF POSITION:

Maintain and improve as needed a GMP compliant document control function with appropriate processes, procedures, and practices.

Create, review, or approve standard operating procedures (SOPs) to build and refine GXP quality systems suitable for late development and commercial product.
Create and implement a system for the review and approval of product specific CMO documentation.
Create a system for the management of templates for protocols, reports, and forms.
Ensure current versions of controlled GMP records, labels, or documents are readily available to site personnel. As needed; verify as true copies. and reconcile returned documents.
Assess and maintain the document control system in compliance with all applicable regulations.

Manage the change control system to ensure compliance with regulations. Assess compliance risk(s) associated with any change requests and their requirements; partner with stakeholders.

Track change notifications from CMO and CTL, and report on any issues.

Establish and operate the GXP training programs and manage training records.

Work with department heads to develop training matrices for key positions.

Regulatory inspections for the Berkeley site.

Provide QA system support during regulatory inspections with document retrieval function, inspection logistics oversight; other functions as required.

Represent Quality Assurance at meetings, as appropriate and may lead MRB as well as make final quality unit judgments.
Track CAPA actions for closure; assure that site managers are informed
Support technical transfer of GXP documents and records between functional groups and across sites with suitable documentation functions.
Administer the quality exceptions system and coordinate responses with appropriate department managers.
Provide QA expertise, advice, or assistance to other departments as required.
Create and maintain monthly QA metrics reports.
Establish and maintain a work environment that fosters learning, respect, open communication, collaboration, integration, and teamwork.
Other duties as assigned.

EXPERIENCE AND QUALIFICATIONS:

BS/BA or MS in life sciences and at least 8+ years experience in quality operations or development in the biotechnology or pharmaceutical industry for the senior manager position plus 3+ years of progressive management experience is required.
Knowledge of FDA regulatory requirements for biologics (especially vaccines) or pharmaceuticals.
Experience with quality systems for development; commercial product experience a plus.
Must have excellent communication and interpersonal skills and proven ability to establish collaborative relationships.
Excellent organizational; documentation under GMP skills.
Proven ability to establish collaborative working relationships; team oriented and able to work independently.
Ability to prioritize and manage multiple projects and tasks.
Strategic thinker with ability to assess, decide, and communicate relative risks to a diverse cross-functional team.
Flexibility, integrity, action and goal oriented.
Highly preferred: experience with regulatory inspections or experience setting up a document control system
Proven ability to oversee controlled document system under cGMP

To apply for a position send your resume to Jobs@JGBBioPharma.com

3) Compliance Manager – 6 month contract (Pennsylvania) 123

DESCRIPTION:

The primary purpose of the compliance manager is to support the R&D QA team.

Activities include training coordinator, eroom coordinator, prepare monthly quality metrics trending and report, author/update site Quality procedures, provide preliminary review of qualification/validation protocols/datapacks/reports, assist in coordinating internal and external audits, and provide administrative assistance support (e.g. maintaining/updating hardcopy files) for the QA team.

EXPERIENCE AND QUALIFICATIONS:

Skills required are general computer skills (Word, Excel, etc), good interpersonal and planning skills, and understanding of GMP requirements.
Experience in Quality Assurance and/or qualification/validation preferred.
Education requirements are a B.S. degree in science, chemistry, engineering or biology fields preferred.
A minimum of 2 years experience in the pharmaceutical industry required.

To apply for a position send your resume to Jobs@JGBBioPharma.com

4) Sr. Manager, Quality Assurance Commercial Product – Full Time Position (San Francisco Bay Area) PB56G

DESCRIPTION:

This position may propose operational objectives and assignments which are approved by senior management. The job holder may participate in developing, improving, and executing company policies that affect immediate operations(s) and may also have companywide effect. This level position works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors. At the senior manager level, exercise judgment within broadly defined practices and policies in proposing methods, techniques and evaluation criteria for obtaining results.

Act as the QA designated subject matter expert for commercial product(s). Coordinate and/or perform QA activities related to commercial product(s) compliance and operations. Duties will include but are not limited to assurance of commercial product quality, oversight of exceptions, and assuring timely and meaningful resolution of potential quality issues that affect the commercial product(s).

Decisions may impact project timelines and/or affect compliance risk.

MAJOR DUTIES OF POSITION:

Manage the quality activities related to the Company’s commercial product(s) including preparing the annual product quality report.
Maintain knowledge of commercial product – from product history to current.
Review batch records and recommend batch disposition as required.
Convenes the Materials Review Board as needed for commercial product quality issues. Identifies, review quality issues, develop proposals and decides with input from QA management. Implement decisions and/or corrective actions, etc., that concern the commercial product(s).
Establish and maintain effective working relationship with key stakeholders both internal and external.
Review all exceptions or concerns involving commercial product(s), including but not limited to regulatory inspections, complaints, adverse events, non-conforming products, etc. Make appropriate notification to senior management, and propose remedies.
Work closely with Regulatory Affairs to assess changes and exceptions for regulatory impact, and to assure appropriate notification to regulators occurs.
Stay abreast of current regulatory trends and changes.
Work with the key stakeholders to assure resolution of compliance issues;
Notify management when significant potential exists for serious compliance issue to impact the supply chain.
Support the Quality team during regulatory inspections related to commercial product(s). Provide guidance to the team, act as QA product representative during regulatory inspections.
Represent Quality Assurance at meetings and ensure compliance of approved quality agreements with CMOs. May propose changes to quality agreements as needed.
Oversee outsourced commercial product complaints.
Coordinate with production, Quality Control, and other departments to ensure quality compliance and operations at all times.
Provides quality expertise, advice, and/or assistance across the organization as required.
Maintain a work environment that fosters learning, respect, open communication, collaboration, integration, and teamwork.

EXPERIENCE AND QUALIFICATIONS:

BS degree in life sciences, bioengineering, or related field and 8 years of experience in biopharmaceutical or vaccine industry, with 2 years experience in QA/QC supporting commercial product(s).
Knowledge of FDA regulatory requirements for biologics, especially vaccines or pharmaceuticals.
Experience with late stage products including licensure and commercial stage.
Experience with regulatory inspections and licensure as well as national and international requirements.
Proven ability to establish collaborative working relationships with internal and external stakeholders; strong team-orientation and the ability to work independently.
Ability to travel 20% of the time

To apply for a position send your resume to Jobs@JGBBioPharma.com

5) (Associate) Director Quality Assurance (Full time position; San Francisco Bay area) X55SS

DESCRIPTION:

Seeking a QA Director / Associate Director to support the manufacture of Drug Substance and Drug Products at Contract Manufacturing Organizations (CMOs) to ensure that drugs are in compliance with Good Manufacturing Practices (GMP) and are of the appropriate quality for their intended use. The position involves quality oversight of CMOs and liaison of quality related issues with Chemistry, Manufacturing and Control (CMC) Team and functional management. The scope of the position encompasses oversight of all aspects of drug manufacture through clinical development and into commercial phase.

Responsibilities:

The successful incumbent will be the QA Representative on CMC Teams responsible for drug manufacture. The position will require regular interaction with QA management at both the CMO and on matters concerning the product quality and CMO GMP compliance. This may include, but is not limited to:

Establishing Quality Agreements with CMO’s
Master Batch Record (MBR) review and approval as compliant with good manufacturing practice regulations, regulatory filings and quality agreements.
Review of executed batch records, Certificates of Analysis and other documents to enable drug substance and final drug product release certifying batches as GMP compliant.
Reviewing and communicating deviations at CMOs to CMC Teams and functional management. Obtaining and communicating ’s deviation investigation requirements to CMOs and working with CMOs to investigate deviations until resolved.
Review equipment qualification protocols and reports.
Communication of changes between and CMOs. Monitoring documentation and implementation of changes until completed successfully.
Performance of contractor quality system reviews and gap analysis as part of CMO selection and maintenance.
Working with new CMOs to certify them as ready to begin manufacture of products intended for administration to humans. This includes review and approval of contractor documentation necessary for the manufacture and testing, as well as approval of technology transfer protocols, discrepancies, deviations and reports.
Conduct GMP compliance audits of contractors and suppliers.
Review CMC sections of regulatory filings.
Provide support in the preparation for and during governmental regulatory agency inspections of and ’s contractors.
Developing, refining, and managing internal Quality Systems.

EXPERIENCE AND QUALIFICATIONS:

Bachelors degree in chemistry, biology, microbiology, industrial pharmacy or other related scientific discipline with a minimum of 7 years experience in QA oversight of pharmaceutical development and manufacturing.
Knowledge of cell culture and purification processing and associated batch record review of biologic manufacturing a must.
Experience with API and chemical drug product manufacturing QA oversight
Experience with QA oversight of manufacturing of both Clinical Trial Materials (CTM) and Commercial Products.
Practical knowledge of cGMPs and an ability to apply sound judgment and decision making skills (risk based and appropriate for the phase of clinical development) in order to evaluate product release.
Working knowledge of US and EU cGMP regulations and guidelines.
Experience in auditing suppliers and CMO’s
Strong planning and time management skills and ability to prioritize own work.
Strong leadership and influencing skills a must.
Knowledge of regulatory compliance of medical device manufacturing a plus.
Some travel required.

To apply for a position send your resume to Jobs@JGBBioPharma.com

6) Sr Document Control Specialist – Full time position Or Contract if preferred (San Francisco Bay Area) U54SH

DESCRIPTION:

This position reports to the Manager Document Control QA

Process documents through the electronic Controlled Document Management System (CDMS) the coordinator role. This includes word processing of documents and checking for format, spelling, grammar and punctuation, scanning documents and importing files.
Use of Sharepoint and Microsoft Access; and a new system to be determined
Assist users in the use of CDMS and provide users with Document Control support.
Distribute controlled document hardcopies and an up-to-date document index to booksets.
Publish and maintain an up-to-date controlled document index.
Assist with troubleshooting issues, making improvements and change control for CDMS and work with users for implementation as required.
Issue and maintain controlled logbooks.
Issue controlled document hardcopies.
Assign various control numbers in controlled logbooks.
Maintain the Quality Assurance file room.

Maintain the employee training binders.
File employee training records, equipment temperature/humidity controlled charts, stability protocol amendments, vendor documentation, controlled logbooks and other documentation as required.

EXPERIENCE AND QUALIFICATIONS:

Bachelor’s degree, preferably in Business Administration/Management, Computer Science or a Life Science.
5+ years of demonstrated experience in a Document Control role in the pharmaceutical and/or biotechnology industries. Experience in the medical device industry a plus.
3+ years of experience using an electronic document management system. Microsoft Access and Sharepoint experience is preferred.
Must be proficient in using the Microsoft Office suite of products (Word, Excel, PowerPoint, Visio, Access and Outlook) and Adobe Acrobat.
Working knowledge of FDA Regulations, including 21 CFR Parts 11, 210, 211 and 820.
Must possess excellent proofreading skills to identify spelling, grammatical, punctuation and formatting errors for correction.

To apply for a position send your resume to Jobs@JGBBioPharma.com

7) Regulatory/ QA Consultant (San Francisco Bay Area) F67VG

DESCRIPTION:

Seeking seasoned professional with experience setting up systems to enable smooth IND submissions
IND submission experience required
Small molecule experience preferred

To apply for a position send your resume to Jobs@JGBBioPharma.com

8) QA/Regulatory Document Control Consultant (San Francisco Bay Area) Q67TL

DESCRIPTION:

Recommend an industry best practice with regards to document management in a small startup development environment
Experience with IND formats and filing requirements
Experience with developing and authoring standard operating procedures
Background in technical writing, editing, regulatory submissions, document control

To apply for a position send your resume to Jobs@JGBBioPharma.com

9) Global Senior Quality Risk Specialist – Full Time Position (San Francisco Bay Area) G62SY

DESCRIPTION:

Follows up of mitigating activities with business partners and prepares mitigating action tracking report.
Supports risk assessments for area of responsibility and collaborate with business partners in collecting information/data for the risk assessment.
Ensures the appropriate use of the Quality Risk Management (QRM) system (mitigating action) and provide ongoing feedback for improvement on mitigating actions.
Ensures that quality issues are addressed in a timely manner and that relevant management functions in the organization are kept informed.

Key Responsibilities and Tasks

Provides overview to Team Leader (Principal QRS) and Head of Quality Area whether identified risks are being mitigated by business partners or not.
Provides overview on MAs & CAPAs planned and implemented.
Tracks and monitors whether de-risking and mitigating Actions (MAs)/CAPAs are taken in a timely manner.
Provides input in and, when requested, is part of a Quality Area Team (QAT).
Provides input into the Quality Risk Management (QRM) validation strategy.
Reviews CAPA activities emerging from audits, mock and regulatory inspections. Manages CAPAs of outsourced audits and Compliance Audit Tool (CAT) activities.
Develops and maintains applicable levels of awareness, expertise in international GCP/PV regulatory requirements, policies, SOPs and project-specific procedures applicable to the clinical trial methodology and Pharmacovigilance processes
May be assigned to one project/program/team/entity as a contact point for guidance and coaching.

EXPERIENCE AND QUALIFICATIONS:

Bachelor’s degree or equivalent in scientific or quality-related field or equivalent combination of education, training and experience
3 years experience in pharmaceutical /biotechnology industry in the area of clinical development process and/or IT and computerized systems
Demonstrated knowledge of GxP and Pharmacovigilance and applicable regulatory requirements.
Proven project management skills and able to work collaboratively in a global environment and lead a team in a matrix organization
Demonstrated analytical, problem solving and decision-making skills.
Proven coaching and mentoring skills.
Fluent in English, knowledge of another European and/or Asian language is desirable.
Travel up to 20%.

To apply for a position send your resume to Jobs@JGBBioPharma.com

10) Manager, Document Control – Full Time Position (San Francisco Bay Area) JH54D

DESCRIPTION:

Responsible for controlling and directing the activities of the Document Control staff in accordance with company requirements. Responsible for managing the implementation all aspects of the Company’s Document Management programs with respect to conformance to the regulatory and quality requirements for the manufacture of pharmaceuticals and drug delivery devices as required for Food and Drug Administration (FDA) and international regulatory agency approval. Job functions must be performed in accordance with the Company’s policies and procedures for quality, regulatory compliance and safety. Acts as departmental liaison for document center. Reports to Senior Manager level or above.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Manages and prioritizes the activities of the document control staff
Manages the administration of the corporate wide document control system, and the integration of electronic documentation into the controlled document system
Authors Document Control standard operating procedures and work instructions
Manages the administration of all Document Control procedures
Manages the creation and administration of file naming conventions and standards for consistent file names and file structure hierarchies
Provides guidance to business partners by providing technical solutions to Document Control issues
Conducts document control training
Provides leadership for continuous improvement activities
Implements tactical plans with little or no supervision
Develops and reports quarterly document control key performance indicator metrics to the management team.
Directly supervises employee(s)

EXPERIENCE AND QUALIFICATIONS:

Frequent interaction with clinical vendor company representatives or functional peer group managers.
Interaction with senior management involving cross-functional contractual issue resolution.
Performs a diverse scope of complicated tasks.
Has wide-ranging experience in area of specialization.
Uses professional concepts and company objectives to resolve moderate to complex issues in creative and effective ways.
Frequently applies technical standards, principles, theories, concepts and techniques.
Applies strong analytical and business communication skills.
Organizes and prioritizes numerous tasks and completes them under time constraints.
Applies technical standards, principles, theories, concepts and techniques.
Demonstrated success in problem solving.
Experienced professional with a full understanding of area of specialization.
Proficient with broad use computer applications such as MS Office and specialized applications, as needed for job.
BS/BA degree in related discipline and five years of related experience; or,
MS/MA degree in related discipline and three years of related experience; or,
Equivalent combination of education and experience
Typically requires a minimum of 8-12 years of related experience and/or combination of experience and education/training.
Drug delivery experience preferred.
Ability to recognize deviation from accepted practice and to exercise judgment in resolving routine problems
Must be able to communicate with engineering personnel and have a good command of technical English.
Working knowledge of standard drafting practices is preferred.

To apply for a position send your resume to Jobs@JGBBioPharma.com

11) Sr Document Control Specialist – Full Time Position (San Francisco Bay Area) V55SS

DESCRIPTION:

Process documents through the electronic Controlled Document Management System (CDMS) using Documentum for the coordinator role. This includes word processing of documents and checking for format, spelling, grammar and punctuation, scanning documents and importing files.
Train users in the use of CDMS in one-on-one and group settings.
Create or update CDMS training materials and presentations as necessary.
Assist users in the use of CDMS and provide users with Document Control support.
Distribute controlled document hardcopies and an up-to-date document index to booksets.
Publish and maintain an up-to-date controlled document index.
Assist with troubleshooting issues, making improvements and change control for CDMS and work with users for implementation as required.
Issue and maintain controlled logbooks.
Issue controlled document hardcopies.
Assign various control numbers in controlled logbooks.
Maintain the Quality Assurance file room.

Maintain the employee training binders.
File employee training records, equipment temperature/humidity controlled charts, stability protocol amendments, vendor documentation, controlled logbooks and other documentation as required.

Issue reports for biennial document currency reviews and monitor document change status.
Manage the offsite storage for Quality Assurance documents and records.
Provide metrics related to the document management process.
Create and revise Document Control related SOPs, work instructions, lists, forms and logs as necessary.
Act as the delegate for reviewing and approving Document Control related documents.
Act as the back-up to represent Document Control during regulatory agency inspections and provide the necessary documentation as requested.
Participate in internal audits of Document Control as necessary.

EXPERIENCE AND QUALIFICATIONS:

Bachelor’s degree, preferably in Business Administration/Management, Computer Science or a Life Science.
5+ years of demonstrated experience in a Document Control role in the pharmaceutical and/or biotechnology industries. Experience in the medical device industry a plus.
3+ years of experience using an electronic document management system. Documentum experience is preferred.
Must be proficient in using the Microsoft Office suite of products (Word, Excel, PowerPoint, Visio, Access and Outlook) and Adobe Acrobat.
Working knowledge of FDA Regulations, including 21 CFR Parts 11, 210, 211 and 820.
Strong organizational and written/verbal communication skills are essential.
Must possess excellent proofreading skills to identify spelling, grammatical, punctuation and formatting errors for correction.
Ability to develop and present training materials.
No relocation provided.

To apply for a position send your resume to Jobs@JGBBioPharma.com

12) GCP Inspection Specialist – Full Time Position (San Francisco Bay Area) S62BG

DESCRIPTION:

The Inspection Specialist supports our Company’s organizations by coordinating, managing, and preparing for Good Clinical Practice (GCP), Pharmacovigilance (PV), and Investigator Site inspections conducted by global health authorities. This position is in the Quality department.

Major Responsibilities and Accountabilities

Coordinates scheduling and logistics for inspection related activities.
Collaborates with other Pharma functional areas for activities related to inspection preparation. Activities include, but are not limited to, preparation of relevant materials and conducting inspection related training.
Participates in pre-inspection visits of investigator sites.
Participates in health authority inspections and helps ensure that roles and responsibilities have been defined and assigned for each inspection. Assumes a role as required by the scope and nature of the inspection.
Provides guidance to inspected parties regarding the completion of inspection corrective and preventative action plans (CAPAs).
Assists in the preparation, conduct and management of mock inspections conducted of our Company’s functional areas.
Assists in developing and maintaining policies, standard operating procedures (SOPs), and guidelines for preparation and conduct of inspections within our Company’s Pharma.
Assists in preparing periodic summary reports and trend reports related to company inspections.
Develops and maintains expertise in international GCP regulatory requirements, international PV regulatory requirements, and policies, SOPs and project-specific procedures within Pharma applicable to the clinical trial methodology and Pharmacovigilance processes.
Monitors trends in health authority inspection activities to proactively identify potential areas of risk for the company.
Responsible for the coordination of Inspection Readiness (IR) modules and if required provides a country-specific /function-specific summary report.
Provides support to the IR Program Manager.
Provides support to and communicates with Inspection Readiness Key Contact (IRKC) personnel globally.
Assists in identifying needs for updates to training materials, IR modules and all documents required for the IR program.

EXPERIENCE AND QUALIFICATIONS:

Minimum of a Bachelors degree in a scientific or health-related field with at least 5 years of relevant industry experience
Minimum of 2 years in quality assurance/compliance required with a working knowledge of GCP and PV regulations.
Prior auditing and/or or health authority inspection experience highly desired.
General computer proficiency (e.g., Microsoft Office Suite applications).
Proven project management skills
Ability to work both independently and in a team environment
Strong communication skills; verbal and written
Critical thinking and decision-making skills
Detail-oriented with the ability to prioritize, organize, plan and manage multiple tasks efficiently
Prior participation in GCP and/or PV inspections is desirable
GCP experience required for consideration.

To apply for a position send your resume to Jobs@JGBBioPharma.com

‘) Manager / Sr. Manager GLP QA – Full Time Position (San Francisco Bay Area) S56GJ

DESCRIPTION:

This position is responsible for all functional Quality Assurance activities in the development, implementation and maintenance of Good Laboratory Practice (GLP) activities. The incumbent will work with the key stakeholders in R&D and other research personnel, to assure GLP studies are performed and documented in accordance with current regulatory requirements and conducted under QA review and oversight.
The incumbent in this position is a subject matter expert who uses professional concepts in accordance with company objectives to solve complex problems in creative and effective ways. Manager level staff provides guidance to subordinates to achieve goals in accordance with established policies. The work is reviewed and measured based on meeting objectives and schedules.
At this level, this position is expected to work on problems of diverse scope in which analysis of situations or data requires an evaluation of identifiable factors and exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions/results. Erroneous decisions or failure to achieve goals results in additional costs and personnel, and serious delays in overall schedules.

Major duties of position:

Review and approve all protocols, reports, and records that must comply with 21CFR58 and/or OECD GLPs on behalf of QA Department. Approve or reject studies as appropriate and issue the compliance certificates.
Collaborate and cooperate with key stakeholders and other research staff to assure compliance in GLP activities. Provide advice and feedback regarding GLP compliance; perform internal audits as required, to assess compliance.
Qualify external GLP laboratories and contract organizations by performing or overseeing audits, keeping a schedule, and auditing studies as required.
Notify management of significant and/or serious compliance concerns, deviations, and gaps; propose mitigation strategies.
Provide general GLP training and consult on GLP matters to internal staff as needed.
Establish and maintain GLP quality metrics, to include in QA quality trend reports.
Assist in communications with Subject Matter Experts (SMEs), Study Director, and contract laboratory organizations (CLOs), as appropriate, on quality related issues to facilitate corrections, clarifications, and resolution of associated quality issues.
Create and refine SOPs to assure that GLP compliance is in compliance and efficient. Follow up on exceptions with appropriate CAPA and support other departments in achieving timely closure of CAPA.
Manage quality agreements with external GLP testing laboratories.
Compile and organize executed GLP record documentation, which includes, but is not limited to, protocol deviations, report, analytical data package, together with associated documentation.
Develop and implement QA systems and SOPs.
Update and maintain Quality Assurance Operations logs and databases, and generate metrics as needed.
Coordinate and assist in the resolution of moderately complex deviations, Out-of-Specification (OOS) / Out-of-Trend (OOT) investigations, or any other quality events as directed by QA management.
Participate in internal audits and support external audits.
Establish and maintain a work environment that fosters learning, respect, open communication, collaboration, integration, and teamwork.
Other duties, including GMP support, as assigned.

EXPERIENCE AND QUALIFICATIONS:

Bachelors Degree (BA/BS), preferably life science with 4 to 8 years’ experience in GMP Quality Systems that support pharmaceutical product development and lot release.
Must have working knowledge of 21CFR58 (GLP regulations)
Knowledge of OECD GLP a plus.
Auditing Certification or equivalent experience is required.
Experience working with contract laboratory organizations is highly desirable.
Excellent organization, communication and presentation skills are a must.
Proven ability to identify quality issues/discrepancies and effectively and proactively resolve the issues/discrepancies in a diplomatic, flexible and constructive manner.
Must have excellent attention to detail, time management and investigative skills as well as the ability to manage multiple priorities with aggressive timelines.
The ideal candidate is self-motivated, and directed; is able to work independently as well as in a team environment.
Must have knowledge of project management concepts, have the ability to adapt to changing priorities, and deliver on objectives.

To apply for a position send your resume to Jobs@JGBBioPharma.com