Sr Associate II, Quality Assurance

Job Description

This position is responsible for the administration of key functional, tactical, and operational Change Control aspects at the Biogen Research Triangle Park (RTP) facilities. In addition, this role will have above-site responsibilities serving as the Global Business Process Owner for the Change Control Program.

• Oversee the Change Control program at the Drug Substance & Drug Product campuses ensuring that the overall program health and KPIs are maintained.
• Provide continual oversight for the change control program to promote compliance, consistency and operating efficiencies across both RTP facilities.
• Ensure compliance to applicable Quality Policies, Directives, SOPs, agency guidelines and cGMP practices.
• Serve as the compliance subject matter expert on change control at operations and project team meetings
• Facilitate standing change control review board.
• Support site operations during regulatory agency and third-party inspections.
• Conduct formal training, instruction and guidance on change controls.
• Monitor and trend change controls to ensure compliance with cGMP regulations and Biogen procedures.
• Develop and provide metric reports on change controls on a periodic basis.
• Perform compliance review and approval of changes pertaining to GMP processes, methods, facilities, utilities, equipment, and associated computer systems.
• Perform other duties as assigned in support of Site QA

Qualifications

• Minimally BA/BS in Life Sciences or Engineering with 5+ years of relevant industry experience required.
• Strong track record in leading, improving, and maintaining the change control system through coaching, feedback, and reinforcement of change fundamentals with change owners
• Technical expertise in bulk drug substance biologics production or sterile parenteral & biologics fill/finish and visual inspection operations
• GMP review of validation documentation and strong knowledge of equipment/facilities/utility /automation systems
• In-depth knowledge of GMP regulations
• Strong problem solving, interpersonal and organizational skills
• Strong collaborative and influencing skills
• Effective written and verbal communication
• Agency inspection experience
• Previous experience with Quality Systems development
• Knowledge of current global Regulatory Quality requirements

Additional Information

The Sr. Associate II in Quality Assurance Change Control is a key member of the Quality Assurance team, responsible for the coordination and oversight of the site change control program.