Compliance Lead - Manufacturing Technology
About the Job
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.
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together, and driven to make a difference, from innovative research to hands-on community support. Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.
Reporting to the Compliance Manager, Devens Manufacturing Technology, the Compliance Lead position provides support for the commercial manufacture of biopharmaceuticals at Devens through Deviation Investigations and Quality Risk Management (QRM).
The Compliance Lead supports a large-scale, highly-automated cell culture facility on a growing campus with many career development opportunities. This position offers the opportunity to provide highly visible deviation investigation and QRM support to resolve complex problems while meeting quality, schedule, and cost objectives. The successful candidate will be a key contributor in a dynamic and highly collaborative team environment. The candidate will be required to deliver on appropriate objectives and priorities, overcome obstacles, and deliver results within project timelines.
- Conducts and manages resolution of complex deviations, root cause investigations, impact assessments and CAPAs as a Lead Investigator. Demonstrated facilitation skills.
- Liaises with multiple work streams throughout the network as a Lead Investigator
- Proactively identifies and facilitates resolution of obstacles to timely completion
- Leads and participates in cross-functional investigation teams
- Presents investigation findings to key stakeholders and site management
- Utilizes QRM and Operational Excellence principles to facilitate risk-based decision-making, drive continuous improvement, and eliminate waste
- Facilitates Site Risk Assessments
Coordinates Product Robustness investigations
- Represents Manufacturing Technology at various cross-functional meetings
- Minimum of a BS in chemical/biochemical engineering, biological sciences, or a related discipline
- Minimum 5-7 years relevant experience in a technical support or quality role within the biopharmaceutical industry
- Prior experience with SOPs, cGMPs and the know how to work within a regulated environment required
- Prior experience in/knowledge of process scale cell culture and/or separation science required
- Prior experience in leading cGMP investigations utilizing formal Root Cause Analysis tools required
- Prior experience facilitating/participating in Risk Assessments required
- Demonstrated basic project management skills (organization, collaboration, multi-tasking and communication), attention to detail, and the ability to perform well in a team-based environment are required
- Excellent verbal & written communications skills required, including ability to present complex information clearly and concisely
- Excellent interpersonal and collaboration skills necessary to interface with and influence all levels of the organization
Principal assignment is in a modern Large Scale Cell Culture building which requires adherence to various Personal Protective Equipment (PPE) standards.
Together, we make a difference. Bristol-Myers Squibb is one of the world’s BioPharma leaders, committed to delivering innovative medicines as well as nurturing a culture that’s a springboard for progress. Our success depends on building teams of bold, innovative and passionate employees who will help continue to drive us further forward. No matter the role, we are united by our mission and determined to win this fight. And that makes all the difference. If you want to join us, apply now at www.bms.com/careers.