Are you an accomplished QA Manager looking for a place to grow in your career, with a great team, small company feel with big resources? Our client is doing innovative science and moving biologic therapeutics quickly with new projects coming online. Get a sense of true project ownership with the support and mentoring you’ve always wanted.
Manage internal GMP and process development activities in support of IND enabling activities. Also oversee external contract test labs. Ensure project related activities align with project timelines. Provide technical and quality expertise during external laboratory investigations and CAPA’s. Additionally, in this role you will collaborate with Project Management to coordinate project related activities as they pertain to Quality, and provide mentoring to CMC Development QA team.
This role will serve as the QA lead for biochemical characterization assay development efforts; review and approve external testing data, oversee the execution of external stability programs and provide quality oversight of early phase development programs in partnership with the development teams.
Specifically you will:
- Manage contract test labs to ensure appropriate testing and documentation, and turnaround times are aligned with project timelines
- Provide guidance for the resolution of discrepancies, Out of Specification (OOS), investigations and Corrective and Preventive Actions (CAPA) for outsourced testing
- Liaise with Analytical Development for CMC QC testing prioritization
- Collaborate with Project Management to coordinate Quality activities pertaining to project timelines
- Provide technical and compliance guidance for the implementation and maintenance of QC analytical methods
- Review CMC submissions as related to analytical methods and QC activities
- Participate in internal and external audits and regulatory inspections
- Notify Senior Management of potential quality or regulatory issues that may affect delays to project timelines
- Bachelor’s degree in Life Sciences disciplines and 10 years of experience in cGMP lab environment or Master’s degree in Life Sciences disciplines and 8 years of experience in cGMP lab environment.
- A background in Analytical method development, QC and validation.
- Experience leading technical groups focused in Analytical development.
- Experience managing scientific projects and personnel in a GMP environment.
- Knowledge of cGMP, ICH, USP and global compendia regulations and guidance documents
- Experience managing in a GMP environment.
- First hand or intimate knowledge of biochemical, biological and immunological assay development is highly desirable
To apply for this position, confidentially email us here.