Sr Manager (Deviations, CAPAs and Change Control
We are working with a dynamic and growing biotech company dedicated to developing innovative treatments for advanced cancers and infectious diseases. Our mission is to improve patient outcomes through cutting-edge research and development.
Position Overview: The Senior Manager, Deviations, CAPAs, and Change Control will play a critical role in ensuring the quality and compliance of our manufacturing processes. This position will oversee the management of deviations, corrective and preventive actions (CAPAs), and change control processes to ensure adherence to regulatory requirements and company standards.
Role Responsibilities
- Develop and implement effective Quality Systems programs to ensure compliance with clinical and commercial regulatory requirements and standards:
- Develop and implement training to complement the programs
- Manage system administration, system support, mentorship, guidance and training to cross-functional stakeholders
- Monitor programs to ensure consistent execution in compliance with the global procedure
- Track and trend quality data and provide reports to management, ensuring there is active on-going record management to meet timely closure and resolution of actions
- Lead and support quality systems operational mechanisms.
- Review and approve non-product related, central function-owned deviations, CAPAs, and change controls as needed.
- Participate in or lead investigations, complaint response and CAPAs to successful resolution through close collaboration with Manufacturing, Facilities, CXOs, QC and Quality teams.
- Participate in or lead Change Control strategy direction through close collaboration with Manufacturing, Facilities, CXOs, QC and Quality teams.
- Perform periodic audits of the company's Deviation, CAPA, and Change Management systems.
- Provide support and participate as the Subject Matter Expert for the Deviation, CAPA, and Change Management programs during audits and inspections.
- Identify and provide leadership for continuous improvement initiatives for the company related to the Deviation, CAPA, and Change Management programs.
- Participate in internal audits.
Qualifications
- Bachelor's Degree in a life sciences or engineering discipline with 10+ years of progressive experience in a GMP regulated Biologics or Pharmaceutical environment required; or
- Master's degree in a life sciences or engineering discipline with 8+ years of progressive experience in a GMP regulated Biologics or Pharmaceutical environment required.
- Experience in 21 CFR 210/211, 21 CFR 600/610, and 2001/83/EC required.
- 5+ years of experience using electronic quality systems (i.e. DMS, LMS, QMS) required.
- 2+ years of management experience leading cross-functional Quality projects / initiatives preferred.
- Experience in clinical and commercial phase pharmaceutical environment preferred.
- Experience with Contract Manufacturing Organizations preferred.
If you feel you'd be a good fit for this role, please apply in.
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