This position will provide and be directly responsible for a full range of Quality Assurance functions. The range of functions will support programs spanning development through late stage clinical and product commercialization. The Sr. Manger QA (Analytical) – reviews and supports development, pre-commercial through future commercial release and stability quality functions. This position is responsible for quality review of drug substance, drug product and reference standard expiry/retest dating; analytical documentation (e.g. test methods, raw/original data, testing summaries, change controls, OOS/OOT investigations, deviations); stability protocols; stability reports and regulatory filings. This position also reviews and/or approves applicable CSP protocols and reports for equipment, process and method validation.
Key Duties and Responsibilities
- Manage assigned development project(s) as quality lead
- Review applicable project methods, procedures, protocols, reports, batch records, deviations and change controls
- Provide timely communication of project status and any quality issues; escalate appropriately as per internal procedures, regulations and quality agreements
- Suggest and implement compliant solutions to issues with input from team and management as required
- Review and approve early phase method development, validation and transfer protocols and subsequent reports for compliance to internal documents, cGMP, ICH guidance documents and ensures consistency within each program
- Review, advise, and approve development and pre-commercial stability protocols for compliance to internal documents, cGMP, ICH guidance documents and ensures consistency within each stability program
- Review stability documentation (raw data, testing summaries, OOS/OOT investigations, deviations, change controls and CAPAs) and documenting quality review with data integrity certifications, as needed
- Review stability data and reports according to proposed regulatory filings and ensuring programs are cGMP and ICH compliant
- Review, advise, and approve drug substance, drug product and reference standard expiry and/or retesting dating assignments according to cGMP, ICH and internal documents
- Generate Test Summaries and Certificates of Analysis
- Conduct regulatory application data integrity of data and/or documents to be included in submissions
- Work with CMC team and regulatory to ensure timely regulatory submissions
- Prepare, review, approve and/or revise SOPs
- Review, approve, and release clinical packaging batch records and development/clinical shipping and storage temperature excursions
- Conduct, participate and support in-house audits as subject matter expert
- Other duties as assigned
Desired Education, Skills and Experience
- Bachelor’s degree in a scientific field required; advanced degree in relevant discipline preferred.
- Thorough knowledge of cGMP and ICH requirements.
- 10+ years of direct Quality Experience with increasing responsibilities and GMP knowledge
- At least 2 years’ experience managing, organizing and executing stability programs.
- Solid data review skills.
- Strong detail orientation required.
- Ability to communicate effectively both orally and in writing and to establish and maintain cooperative working relationships with persons contacted in the course of performing assigned duties including Company management and outside business associates.
- Excellent organizational skills, and ability to prioritize workflow and to meet established timeframes
- Exceptional self-management ability
- Up to 25 % of travel including international travel required
Location: San Mateo, CA
Type: Full-time: Full Time
Experience: Some Experience