Sr Manager, CMC Quality Assurance
Menlo Park, CA US
Company is seeking a Senior Manager, CMC Quality Assurance, to help lead quality for Company's Client oncology therapies. The Senior Manager of CMC Quality Assurance will be responsible for building the CMC quality assurance processes and providing Quality oversight for the GMP activities throughout the development stages of antibody-based radiopharmaceuticals.
Salary Range : US$ 145K - $180K
- Accountable for master batch records reviews, conduct and/or oversee in-process and final product lot release partnering with multiple CMOs through audits, and batch record and testing approvals.
- Responsible for the implementation and management of electronic Quality Management system (eQMS). Assist with the development, review and approval of quality system including Standard Operating Procedures (SOPs) required for molecularly targeted radiotherapy product manufacturing, packaging, and distribution.
- Manages and oversees change controls, deviations/investigations, CAPAs, vendor qualification, customer complaints, stability studies, regulatory agency inspections, product recalls, and annual product review.
- Supports Quality Management Review on the performance of the quality system, including periodic management reports, management review meetings, and other reviews and recommendations for system improvements.
- Perform and/oversee the completion of internal audits. Coordinate, support and facilitate third party regulatory audits/assessments.
Qualifications, Education & Experience
- Minimum of a Bachelor's degree in life science or equivalent and 8+ years' experience in GXP and Quality Systems in biotechnology, antibody drug conjugated or molecularly targeted radio therapies.
- Demonstrated in-depth experience of establishing, refining, and operating Quality Assurance related systems for clinical manufacturing in the Biotechnology industry.
- In depth knowledge of regulations and guidance supporting phase appropriate cGMP to include FDA, EMA, ISO standards and ICH guidelines with direct impact to clinical programs.
- Experience reviewing and collaborating on regulatory submissions as well as hosting inspections/interactions.
- Experience working effectively with CMOs
Skills and abilities
- A solid understanding of GMPs and CMC requirements is expected.
- Strong knowledge of Quality, Compliance, US & International cGxPs, regulations, product development and manufacturing.
- Must be familiar with ICH regulations and FDA/EMA requirements and expectations, plus experience with health authority inspections.
- Demonstrated thought leadership in CMC Quality Assurance.
- Experience in preparing regulatory filings.
- Strong interpersonal and collaboration skills.
- Excellent verbal and written communication skills.
- Ability to operate in a fast-paced, multi-disciplinary industrial environment.
- Ability to critically evaluate and troubleshoot complex problems and attention to detail.
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