Change Control Manager
• Manage the development change control program in support of the manufacturing and the laboratory areas of Product Development Operations (PDO).
• Serve as the compliance subject matter expert on change control at operations and project team meetings, as well as lead standing change control committee meetings.
• Manage the review and approval process for change control. Lead process and system improvements.
• Responsible for the continued monitoring of change control program and system to ensure that Product Development Quality (PDQ) and PDO comply with industry and BMS quality standards.
- Provide continual oversight for the development change control program to promote compliance, consistency and operating efficiencies across PDQ and PDO. Ensure compliance to applicable Quality Policies, Directives, SOPs, agency guidelines and cGMP practices.
- Serve as a champion for the development change control program ensuring alignment of functional area subject matter experts and key stakeholders and initiate and facilitate resolution of issues.
- Lead the change control program by performing compliance review and approval of changes pertaining to GMP processes, methods, facilities, utilities, equipment, and associated computer systems.
- Lead cross functional change control system improvements to ensure alignment to the overall change control strategy and process.
- Monitors and trends change controls to ensure compliance with cGMP regulations and BMS procedures.
- Provides training, instruction and guidance on change controls and serves as a resource for the development sites.
- Develop and provide metric reports on change controls on a periodic basis.
- Supports site operations during regulatory agency and third party inspections.
- Perform other duties as assigned in support of PDQ and PDO.
- Knowledge of science generally attained through studies resulting in B.S. or M.S. in chemistry, pharmacy or biology or a related pharmaceutical science
- Minimum of 9-11 years experience in pharmaceutical quality and/or operations at a site level, including 3-5 years experience in a regulated function.
- Experience within a QA/QC environment is an asset
- Broad experience in the change control process and regulatory requirements
- In-depth knowledge of GMP regulations
- Strong problem solving, interpersonal and organizational skills
- Strong collaborative and influencing skills
- Effective written and verbal communication
- Computer literacy: Microsoft Office and SAP environment Trackwise®, PDLIMs, and other systems as required (eg DeltaV)