Manager, Quality Compliance (R1551746-en-us)
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
The Manager, Quality Compliance is responsible for management of Inspection Readiness and Self-inspection activities for the Cell Therapy Manufacturing Site located in Devens, MA. You will support programs to improve cGMP compliance, health authority inspection readiness, and quality management at the site. You will partner with different functions (i.e. Operations, Supply Chain, Manufacturing) to proactively identify compliance risks, develop collaborative solutions, and track effective resolution of actions to close compliance gaps. This is an individual contributor position.
Manages the day-to-day activities related to Audits and Inspection Readiness at the Devens Cell Therapy Facility
Supports the site's internal audit program to verify compliance with cGMPs, industry best practices, BMS corporate policies, and applicable regulatory standards
Assists in site readiness and preparation for internal/external audits and health authority inspections; supports backroom operations during health authority/regulatory inspection
Trains SMEs and support staff on specific roles, responsibilities, processes, and systems associated with inspection management and support
Assures communication of compliance concerns, regulatory agency expectations, and industry trends as part of ongoing education and training for cGMP compliance
Interacts on a regular basis with Functional Area Management to ensure that the site is inspection ready with no lead time
Creates, maintains, and communicates metrics that measure the health and effectiveness of the site Compliance programs
Engages in process improvement initiatives as needed to ensure continuous Quality improvement
Qualifications & Experience
Minimum of 6 years of pharmaceutical experience or related GMP industry
Bachelor’s degree or higher in Life Sciences, Chemistry, Engineering, or related field
Experience leading or facilitating audits (internal or external) highly desirable
Experience in Health Authority inspection preparation and management preferred
Detail-oriented with knowledge of cGMP regulations as well as biologics/aseptic/cell therapy regulations
Collaborative, able to establish professional relationships and rapport with internal and external peers and higher-level management
Project management skills including tracking project status, liaising with resources, organizing meetings, and maintaining a SharePoint virtual environment
Innovative, proactive, and resourceful; committed to quality and continuous improvement
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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 with the resources to pursue their goals, both at work and in their personal lives.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to . Visit[Register to View] target="_blank"> [Register to View] to access our complete Equal Employment Opportunity statement.
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