QA Operations Sr. Manager

About the role

The QA Operations Sr. Manager will oversee quality operations across site activities, ensuring compliance with GMP, ALCOA+, and internal standards. They will partner with cross-functional leaders to manage risks, promote continuous improvement, and translate regulatory expectations into practical practices.

Responsibilities

• Provide independent QA oversight and partnership across all operational activities, including incoming materials, warehouse, manufacturing, QC, and product disposition.
• Ensure operational processes are designed and executed in compliance with GMP, ALCOA+ data integrity principles, and internal quality standards.
• Partner with operational leaders to ensure processes are robust, capable of right-first-time execution, and support operational decision-making.
• Ensure timely escalation of significant quality risks to site leadership and the Head of Quality.
• Apply quality risk management principles (ICH Q9) in all operational decision-making.
• Quality Culture & Operational Excellence
• Act as a catalyst for a strong quality culture, providing guidance and coaching to operational teams.
• Ensure QA presence in operations through Manufacturing QA and other QA Operations teams.
• Translate regulatory expectations into practical, meaningful practices.
• Promote proactive identification of risks, operational issues, and improvement opportunities.
• Support teams in analyzing situations, addressing root causes, and implementing sustainable improvements.
• Drive continuous improvement initiatives to enhance process robustness and operational performance.
• Oversight of Quality Events and Investigations
• Provide oversight for quality events impacting operations, including exceptions, non-conformances, and OOS results.
• Drive timely, scientifically sound investigations focused on root cause and effective, sustainable corrective and preventive actions.
• Responsible appropriate escalation, communication, and closure of significant quality events.
• Batch Disposition & Product Release
• Oversee batch record review and product disposition processes.
• Ensure robust review processes support compliant and timely product release.
• Assess and address quality issues impacting batch disposition.
• Sterility Assurance
• Provide leadership for sterility assurance via the Sterility Assurance function.
• Ensure implementation, maintenance, and continuous improvement of the site Contamination Control Strategy (CCS).
• Oversee contamination control practices, aseptic manufacturing, environmental monitoring, and utilities microbiological risks.
• Ensure compliance with regulatory expectations and industry best practices for sterile product manufacturing.
• Continuous Improvement & QA Operational Projects
• Lead QA-driven projects and cross-functional improvement initiatives.
• Promote structured problem solving, risk management, and sustainable implementation of improvements.
• Ensure QA support for operational transformations and site-level projects.

Qualifications

• Bachelor’s or Master’s degree in Pharmacy, Microbiology, Biotechnology, Chemistry, or related scientific discipline.
• 10+ years of progressive experience in Quality Assurance within a regulated pharmaceutical or biotech environment.
• Extensive experience in pharmaceutical or biotech manufacturing under GMP regulations.
• Strong experience in QA oversight of operations and sterile manufacturing preferred.
• Proven leadership in managing QA teams in a regulated environment.

Skills

• Experience in cross-functional operational settings and continuous improvement initiatives.
• Experience partnering with Operations, Quality Control, Engineering, and Supply Chain.
• Ability to influence across organizational levels and drive a strong quality culture.
• Experience in continuous improvement initiatives (e.g., Lean, Six Sigma, or similar).

Benefits

As a global leader in medical imaging, Guerbet offers a competitive salary, continued personal development, and a commitment to diversity, equity, and inclusion. Guerbet is an Equal Opportunity Employer.

Pay

Competitive salary based on experience and qualifications.

Schedule

Full-time position.