Quality Operations Manager, CMC

Role Overview

• Oversee the drug substance (DS), drug product (DP), reference standard, and packaging/labeling/serialization contract service providers (CSPs) for clinical-phase and commercial production activities.
• Review and approve key strategic product/process documents (i.e., specifications, batch records, tech transfer/validation protocols, etc.).
• Support stability program strategy including product shelf life and execution.
• Lead, review and approve change controls, deviations, temperature excursions, investigations, OOX, CAPA, and Product Quality Complaints, gathering necessary SMEs to resolve issues as applicable.
• Perform risk assessment and implement appropriate quality and process controls for production activities.
• Support vendor qualification program, review written reports, follow up to resolve findings, and monitor CSP performance.
• Develop, maintain, and review clinical and commercial Quality Agreements.
• Act as Product Quality Lead in CMC, Program, and CSP team meetings to provide strategic direction and leadership to product development, registration, and approvals.
• Own the APR/PQR, coordinating to ensure regulatory requirements are met and actions managed to conclusion.
• Direct the disposition (release/reject) activities interfacing with a QP where applicable.
• Ensure cohesive collaboration across CSPs for timely review of manufacturing records.
• Ensure robust processes are implemented for product management (e.g., control strategy, technology transfer, process validation lifecycle, quality monitoring).
• Interface with Regulatory Affairs to review and approve regulatory filings (IND, NDA).
• Support pre-approval inspection and commercial readiness activities.
• Participate in hosting regulatory inspections, Support or perform internal and external audits.

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 regulatory standards (e.g., ISO, FDA, ICH, GMP, EMA).
• Proven track record 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.
• Must thrive working in a fast-paced, innovative environment.
• Experience with product monitoring, complaint handling, issue resolution preferred.
• Demonstrates a high level of intellectual curiosity, innovation, and creative problem solving with an entrepreneurial spirit.
• Excellent interpersonal skills, with the ability to develop important relationships that include trust and encourage diversity in all their forms.
• Highly organized and detail-oriented with a passion to deliver quality results.
• Ability to travel domestically and internationally to meet program needs (estimated 15-20%).

Benefits

• 99% premium paid for medical, dental, and vision plans.
• Company-paid life insurance, AD&D, and disability benefits.
• Voluntary plans to personalize coverage.
• Dollar-for-dollar match up to 6% on eligible 401(k) contributions.
• Long-term stock incentives and ESPP.
• Discretionary quarterly bonus.
• Extremely flexible wellness benefit.
• Generous PTO, paid holidays, and company-wide shutdowns.