Manager, Quality Operations, CMC

The Quality Operations Manager, CMC is responsible for assuring product quality and compliance to the manufacture, testing, control, validation, and release of drug substance and drug product for commercial and clinical distribution.

Requirements

• BA or BS degree in Chemistry or related field
• 5+ years in a GMP setting working with clinical and commercial products
• Firsthand experience with interpreting and implementing of regulatory standards (e.g., ISO, FDA, ICH, GMP, EMA)
• 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
• Experience with disposition of product batches and interfacing with a QP and CSPs
• Excellent written, organizational and oral communication skills
• Ability to travel domestically and internationally to meet program needs (estimated 15-20%)

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