Senior Manager, Quality Operations - Commercial & Stability, CMC

Role Summary

Senior Manager, Quality Operations - Commercial & Stability, CMC is responsible for a range of operational activities to assure product quality and regulatory compliance across manufacturing, testing, control, validation, and release of drug substances and drug products for commercial and clinical distribution. The role focuses on management of stability programs and commercial quality oversight, operating at the intersection of Quality, Manufacturing, and Regulatory with emphasis on precision and urgency.

Responsibilities

• Oversee the 3PL contract service providers (CSPs) for commercial production distribution activities.
• Review and approve key strategic product/process documents and records.
• Support commercial stability program management including trending for early Field Alert Reporting notification.
• Support clinical stability program strategy including product shelf life and execution.
• Manage mock recall and recall program.
• Manage the APR / PQR, coordinating cross-functionally to ensure regulatory requirements are met and actions are managed to conclusion.
• Lead, review and approve change controls, deviations, temperature excursions, investigations, OOX, CAPA, and Product Quality Complaints; gather SMEs and lead the team to resolve issues as applicable.
• Perform risk assessment and implement appropriate quality and process controls to ensure proper oversight of all production activities.
• Ensure cohesive collaboration across CSPs for timely review of GMP records.
• Interface with Regulatory Affairs to review and approve regulatory filings (IND, NDA).
• Support pre-approval inspection and commercial readiness activities.
• Support or perform internal and external audits.

Qualifications

• 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 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.
• Experience interfacing with a QP and CSPs.
• Excellent written, organizational, and oral communication skills.
• Ability to thrive in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, and efficient.
• Experience with product monitoring, complaint handling, and issue resolution preferred.
• Demonstrates intellectual curiosity, innovation, and creative problem solving with an entrepreneurial spirit; able to thrive in an agile environment.
• Excellent interpersonal and communication skills with the ability to develop important relationships that include trust and diversity.
• 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%).
• Physical and mental requirements include regular use of a computer and focus; reasonable accommodations available for disabilities.

Education

• BA or BS degree in Chemistry or related field.

Additional Requirements

• Ability to travel domestically and internationally to meet program needs (estimated 15-20%).
• Regular use of a computer and related devices; strong communication and organizational skills; ability to work in a fast-paced environment.