At Bristol-Myers Squibb, we believe that together we can make the difference. We want to do this by building professional teams who can create and innovate medicines that benefit doctors and their patients.
Our large-scale biologics manufacturing facility in Devens, Massachusetts, is expanding and there are a number of exciting career opportunities to join Bristol-Myers Squibb, one of the world’s leading BioPharma companies.
We’ve created one of the world’s premier biologics facilities, among the first sites in the industry to have a fully automated, integrated manufacturing control system that enables the plant to run virtually paperless. It is a site that combines biologics development with clinical and commercial manufacturing on a single campus – a true biologics center of excellence for the company where teams are encouraged to closely collaborate. This expansion was designed to support the launch of new medicines by more closely aligning biologics development and manufacturing capabilities. All this goes towards helping create and innovate life-saving medicines that fight serious illnesses.
1. Acts as Site Gatekeeper for change control program, maintains site change control procedures, identifies and implements quality system improvement opportunities, represents site in network change control program initiatives, supports inspections/audits as a subject matter expert on the change control program.
2. Reviews and assesses more complex policy/directive revisions, network regulatory observations, and compendia updates against site processes, procedures and methods. Leads remediation plans for major impact or complex observations. Ensures all commitments are tracked for timely completion.
3. Acts as a support auditor and/or lead auditor for site self-inspections. Develops, plans and conduct audits, writes audit reports, reviews and tracks corrective actions and audit closures. Identifies areas for continuous quality system improvement and maintains self-inspection procedures.
4. Manages program metrics process by developing and improving applicable tools and trackers, generating and analyzing quality system data for trending, performance deficiencies, and conformance to KPIs. Develops appropriate action plans as needed to remediate or continually improve on quality system performance. Presents related metrics and action plans to site Quality and operations management.
5. Leads completion of annual product quality reviews including project management, compilation of report sections and driving review/approval by established timelines.
6. Core inspection team member. Leads SME preparation room / back room during inspections, or supports front room activities. Executes targeted inspection preparation activities. Generates Quality System queries and reports as needed for audits and change control programs during inspections.
7. Develops and conducts user training on self-inspection, inspection readiness and change control program as needed.
• A minimum of 6 or more years of relevant experience in a biologics or pharmaceutical manufacturing environment is required. Prior GMP compliance / Quality Systems experience is preferred.
• Knowledge of science or engineering generally attained through studies resulting in a Bachelor’s degree in a scientific or technical discipline.
• Strong project management skills (organization, collaboration, multi-tasking and communication), high degree of attention to detail, and the ability to perform well in a team-based environment are required.
• Excellent computer skills and proficiency with MS Office is required. Advanced knowledge of Excel preferred.
• Basic understanding of manufacturing processes, drawings and specifications and quality systems, including knowledge of applicable U.S. and E.U. cGMP regulations/guidance pertaining to change control required.
• Demonstrated ability to effectively establish proper priorities and to communicate complex information clearly and concisely, with demonstrated knowledge of subject matter related to quality and compliance.
• Previous work experience with TrackWise and responsibilities related to metrics and data analysis preferred.
• Candidate must be familiar with and able to interpret relevant regulations, regulatory agency inspection expectations e.g. FDA, EMA, Health Canada, etc
At least 6 year(s)
Posted / Updated: