Manager, Quality Control

Quality Control Manager

Responsibilities:
- Ensure analytical CMO laboratory activities comply with cGMP.
- Critically review analytical test packages for release, in-process, and stability testing (DS and DP) to verify methods/procedures are followed and documentation is complete/accurate.
- Review analytical data for release, stability, and in-process testing in a timely manner.
- Oversee laboratories, including investigations for out-of-specification, out-of-trend, deviations, and/or anomalous results.
- Follow up with contract laboratories to correct deficiencies/omissions in test packages.
- Submit test packages to QA for review and load all data into the electronic storage program.
- Review analytical data related to reference standard qualification, method validation, and method transfer.
- Travel as necessary to analytical testing sites or other sites.

Where You’ll Work:
- U.S. remote; quarterly (or as needed) visits to the San Francisco office.

Qualifications / Skills:
- M.S./B.S. in life sciences (ideally Chemistry/Analytical Chemistry).
- 5+ years’ Quality Control experience in a pharmaceutical setting with strong cGMP knowledge.
- 2+ years management experience.
- Ability to communicate effectively with vendors.
- Demonstrated strong analytical skills and ability to work independently against multiple deadlines.

Compensation & Benefits (as stated):
- Salary (CA): $144,000–$159,700 USD.
- 401(k) with employer match; ESPP; health, HSA/FSA, paid leave, and other listed benefits.