Director of Q&A GLP &GMP EnVivo Pharmaceuticals
THIS JOB HAS EXPIRED Position Summary:
Reporting to the Senior Director of Quality Systems, the Director of Quality Assurance Good Laboratory Practices (GLP) & current Good Manufacturing Practices (cGMP) will provide quality support and oversight for key functional areas operating within the nonclinical (GLP) and Chemistry Manufacturing and Controls (CMC) groups. The Director of GLP & cGMP will establish and execute quality systems associated with GLP and cGMP. The Director will also be responsible for overseeing the internal and external GLP & cGMP quality audit programs designed to ensure EnVivo remains in a state of compliance and to ensure contract service providers and suppliers meet EnVivo' quality standards.
The position is responsible for the application of quality systems necessary for the manufacture and release of clinical active pharmaceutical ingredient (API) and drug product (DP) and labeled clinical trial material. The individual will provide strategic as well as tactical support to the EnVivo Pharmaceuticals quality systems department/functional area.
Quality Assurance Responsibilities:
Implementing and improving GLP & cGMP quality systems for EnVivo drug development efforts.
Ensuring compliance to applicable EnVivo regulatory and quality SOPs and policies, FDA guidance rulings, good laboratory (GLP), and current good manufacturing practices.
Supervising and/or conducting the required reviews for release of active pharmaceutical ingredients (API), drug product (DP) and labeled clinical trial material pursuant to the CFR and EnVivo SOPs
Oversee and approve drug development validation efforts (e.g. analytical, API, and DP process as well as computer software 21CFR 11 ).
Engage and work with a Qualified Person (QP) to work directly with EnVivo to ensure appropriate release procedures pursuant to other international regulatory requirements.
Conduct audits or supervise auditors of EnVivo selected contract GMP/GLP vendors.
Audit/review regulatory GLP and cGMP submission sections for accuracy and completeness.
Oversee corrective actions that are outcomes of GLP and cGMP quality audits
Preparing quality reports and metrics associated with efforts in the cGMP and GLP quality area
Work with the Senior Director of Quality Systems to insure inspection readiness (e.g. PAI or other) for FDA or other regulatory inspections related to EnVivo quality systems with emphasis on GLP and cGMP areas.
Represent the company during FDA GLP & cGMP-related inspection.
Maintain ongoing awareness and understanding of any new GLP or cGMP requirements or guidances from the FDA or other regulatory agencies and work with the Senior Director of Quality Systems to insure dissemination and timely incorporation of said new requirements.
1. BS/BA Degree or equivalent work experience
2. Ten (10) to fifteen (15) years pharmaceutical experience in a regulated drug development environment (GMP or GLP).
3. Demonstrated knowledge of current US and European GMP and GLP regulatory requirements.
4. Experience managing GMP/GLP regulatory inspections and presenting to regulatory inspectors
5. Five years of supervisory experience.
6. Strong problem-solving and risk-based decision-making skills.
7. Excellent communication and interpersonal skills with the ability to interface cross functionally and at multiple levels.
8. Strong negotiating and influencing skills.
9. Previous experience working with contract manufacturing organizations preferred.
Degree in chemistry or other related applied science.
||Watertown, MA |
THIS JOB HAS EXPIRED