Manager, Quality Assurance

Responsibilities

• Serve as the quality contact for external manufacturing partners producing sterile drug products, establishing and maintaining quality oversight of clinical manufacturing activities.
• Manages clinical lot disposition for sterile drug product, including review of batch records, analytical results, and compliance with Regulatory Dossiers.
• Responsible for the review and approval of process validation documents, protocols and reports, Master Batch Records and Executed Batch Records at the Contract Development and Manufacturing Organization (CDMO).
• Provides QA oversight during technology transfer activities for new clinical products moving into CDMO sites.
• Makes sure contract manufacturer performance is monitored through routine reviews, meetings, and quality metrics.
• Utilizes GMP-regulated quality management systems, including document control, change control, deviations/complaints, and corrective and preventative actions (CAPAs).
• Facilitates the creation, review, and approval of relevant SOPs and work instructions relevant to CMC activities.
• Supports QA during CDMO audits, including participating in audit execution.
• Supports regulatory filings (e.g., Investigational New Drugs (INDs), Annual Reports, Stability Reports) by reviewing data, ensuring compliance with regulatory procedures.

Qualifications and Skills

• Bachelor’s degree in a scientific discipline (Chemistry, Biology, Engineering, or related field)
• A minimum of 5 years of relevant experience in the pharmaceutical industry, with established Quality and Compliance knowledge in supporting manufacturing of sterile products.
• Demonstrated experience providing sponsor-side quality oversight of CDMOs for sterile drug products, including batch record review, batch disposition, deviation management, and quality governance.
• Strong understanding of cGMP regulations including FDA CFR Parts 210/211, EU Annex 1, ICH Q7, Q8, Q9, and Q10.
• Detail oriented with strong organizational skills and the ability to manage multiple clinical programs and CDMO relationships simultaneously.
• Self-directed and comfortable with a high degree of autonomy in a small-time, high-accountability environment.

Preferred Experience

• Technology transfer of sterile Drug Products into new CDMO sites.
• Experience with lyophilized products, pre-filled syringes, or other complex sterile dosage forms; experience in peptides is a plus.
• ASQ Certified Quality Auditor (CQA) or similar.