Senior Manager, CMC Quality Control

Senior Manager, CMC Quality Control

Location:

Brisbane, CA (Hybrid - 2 days onsite, approx. 35 hours/week)

Length: 6+ months

* W2 Candidates Only, No C2C

Our client is seeking an experienced and motivated Senior Manager, CMC Quality Control (QC) to support clinical and commercial programs. This individual will play a critical role in managing quality control operations for biologics, ensuring compliance with regulatory requirements, and supporting the development of life‑changing medicines. The ideal candidate will have a deep understanding of biologics manufacturing, analytical methodologies, and regulatory expectations (FDA, EMA, ICH).

This is an exciting opportunity to join a high‑performing team focused on delivering innovative therapies for patients with rare and ultra‑rare diseases.

• Lead quality control support for clinical and commercial biologics programs, ensuring compliance with cGMP, ICH, and global regulatory standards.
• Oversee analytical method development, validation, and transfer activities for biologics and related products.
• Review, manage, and organize QC data, including release and stability reports, and generate interim trending assessments.
• Partner with Contract Manufacturing Organizations (CMOs) and contract labs to manage QC testing for release, stability, and method validation/transfer.
• Support QC operations for development, manufacturing, and regulatory activities, ensuring timely completion of deliverables.
• Participate in stability programs and data trending per ICH, FDA, EMA, USP, and Ph. Eur. guidelines.
• Maintain and implement quality systems to ensure integrity and reliability of QC data.
• Initiate and manage quality documentation, including deviations, CAPAs, and change controls in electronic quality systems (e.g., Veeva).
• Assist in OOE/OOS/OOT investigations and ensure resolution aligns with regulatory expectations.

• Bachelor's degree in Biochemistry, Molecular Biology, Pharmaceutical Sciences, or related field.
• 3+ years in analytical/QC within a GMP environment (pharma or biotech).
• Strong knowledge of biologics drug substance processes (upstream and downstream).
• Experience with stability studies per ICH guidelines and familiarity with QC methodologies.
• Proficiency with MS Office and statistical analysis software (Excel, JMP preferred).
• Excellent organizational, project management, and communication skills.
• Pay range $140,000 - $160,000 depending on experience.

POST‑OFFER BACKGROUND CHECK IS REQUIRED. Digital Prospectors is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law. Digital Prospectors affirms the right of all individuals to equal opportunity and prohibits any form of discrimination or harassment.

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