Senior Manager, Quality Operations

📋 Description

• Review executed batch records, Certificates of Analysis (CoAs), Certificates of Compliance (CoCs)
• Review and triage deviations, investigations, corrective and preventive actions (CAPAs), and
• Participate in complaint investigations and help implement the processes, responsibilities, and
• Collaborate with the Senior Director, Quality Operations and Supplier Quality Management
• Work with CDMOs and third-party logistics (3PL) providers to support Drug Supply Chain Security Act
• Serve as a day-to-day Quality Operations contact for CDMOs and the 3PL, coordinating documentation

🎯 Requirements

• A bachelor’s degree in life sciences or a related field, or equivalent relevant industry experience.
• At least 7 years of GMP Quality experience in the biotechnology or pharmaceutical industry, ideally
• Hands-on experience reviewing batch records, product release documentation, analytical results, and
• Experience reviewing deviations, investigations, CAPAs, OOS events, or other quality events and
• Experience working with CDMOs or other external manufacturing partners in an outsourced
• Understanding of the quality and distribution requirements involved in transitioning from clinical

🎁 Benefits

• Annual base salary: $175,000–$190,000 USD, depending on relevant experience, skills
• Additional compensation: Eligibility for an annual target bonus and equity compensation, as
• Healthcare coverage: Medical, dental, and vision insurance.
• Retirement and savings: Access to a 401(k) retirement plan and participation in the Employee Stock
• Insurance protection: Company-paid life insurance and short-term and long-term disability coverage.
• Time off: Paid time off and paid company holidays.