Senior Manager, Quality Operations - Commercial & Stability, CMC

Senior Manager, Quality Operations - Commercial & Stability, CMC. Responsible for overseeing 3PL contract service providers, managing stability programs, and ensuring compliance with regulatory requirements.

Requirements

• BA or BS degree in Chemistry or related field
• 6 + years in a GMP setting working with clinical and commercial products
• Experience managing stability programs
• Direct experience with recall, APR, FAR management
• Firsthand experience with interpreting and implementing of regulatory standards (e.g., ISO, FDA, ICH, GMP, EMA)
• Proven ability to operate independently, influence cross-functionally, and make clear, timely decisions
• Proven track record and experience in supporting regulatory inspections (FDA, EMA)
• Strong knowledge of quality management systems, QC and development processes, and regulatory strategy for small molecule DS and solid oral drug products

Benefits

• 99% of the premium paid for medical, dental and vision plans
• Company-paid life insurance, AD&D, disability benefits, and voluntary plans
• Matching dollar-for-dollar up to 6% on eligible 401(k) contributions
• Long-term stock incentives and ESPP
• Discretionary quarterly bonus
• Flexible wellness benefit
• Generous PTO
• Paid holidays and company-wide shutdowns