Senior Manager Q&A GMP GLP EnVivo Pharmaceuticals
THIS JOB HAS EXPIRED Position Summary:
Reporting to the Director of Quality Assurance Good Laboratory Practices (GLP) & current Good Manufacturing Practices (cGMP) the Sr. Manager of QA GLP/GMP will perform documentation reviews associated with the QA review and release of active pharmaceutical ingredients (API), drug product (DP) and labeled clinical trial material. The Sr. Manager will also be responsible for assisting with internal and external GLP & cGMP quality audits of selected GMP/GLP vendors.
The Sr. Manager will provide tactical support to/for the Director of QA, GLP/GMP.
Quality Assurance Responsibilities
Conducting QA reviews for release of active pharmaceutical ingredients (API), drug product (DP) and labeled clinical trial material pursuant to the CFR and EnVivo SOPs
Review appropriate drug development validation documentation (e.g. analytical, API, and DP process as well as computer software 21CFR 11 ).
Under the direction of the Director of QQ, GMP/GLP work with a Qualified Person (QP) to schedule and ensure appropriate release procedures of material are completed pursuant to other international regulatory requirements.
Audit/review regulatory GLP and cGMP submission sections for accuracy and completeness.
Assist with the preparation of quality reports and metrics associated with efforts in the cGMP and GLP quality area
BS/BA Degree or equivalent work experience
At least eight (8) to ten (10) years pharmaceutical experience in a regulated drug development environment (GMP or GLP).
Experience reviewing relevant documentation and releasing material (API, DP, labeled material) for clinical trial use
Demonstrated knowledge of current US and European GMP and GLP regulatory requirements.
Excellent communication and interpersonal skills with the ability to interface cross functionally and at multiple levels.
Strong negotiating and influencing skills.
Degree in chemistry or other related applied science.
Previous experience working with contract manufacturing organizations preferred.
||Watertown, MA |
THIS JOB HAS EXPIRED