Bristol Myers Squibb Quality Product Compliance Manager – Key Brands in Devens, Massachusetts
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.
Bristol-Myers Squibb is searching for a remarkable Quality Product Compliance Manager-Key Brands to join our phenomenal team. As our Quality Product Compliance Manager (QPCM) – Key Brands, you will support the consistent execution of Quality activities that fall within the Quality Key Brands organization. This includes support of post marketing changes and global change management implementation planning, leading End to End Annual Product Quality Reviews (APQRs) for all commercial Key Brands and advancing key biologics Quality Product Lead (QPL) initiatives and programs. The QPCM works collaboratively with the QPLs, other Global Biologics Quality, Manufacturing Science and Technology (MS&T) and Analytical Science and Technology (AS&T) team members to ensure end-to-end optimization across the Lifecycle of BMS Key Brands.
Major Duties and Responsibilities:
The Quality Product Compliance Manager – Marketed Products collaborates with the Director and Associate Directors, Quality Product Leads for the marketed Key Brand products and the respective Programs.
In addition, this role assists with the planning and execution of the Quality component of the Product Strategic Plan including, Leading the BMS APQR program, Advanced sample program, identifying cross brand opportunities for alignment and consistency where possible, in post approval changes.
The QPCM is responsible for collaborating and networking with the various brand teams and the global Quality organization to reach compliant solutions.
This position will facilitate and be supported by the broader Quality Product Lead organization and Global Quality organizations through established aligned objectives and defined roles and responsibilities.
Support the APQR GPO and GPL.
Advance the End-to-End Annual Product Quality program by leading the E2E APQR process for assigned brands, providing an in depth quality review as well as project management.
Lead the authoring of End-to-End Annual Product Quality Reviews for Key brands.
Lead continuous improvement projects in the QPL function to improve Quality Systems and processes, supporting the team with development and utilization of tools for providing standardized work and communications for QPL team.
Support and lead continuous improvement for the Advanced Sample strategy.
Lead cross-functional team meetings that support the Quality Organization.
Advise change record authors on ensuring an integrated approach to change controls and related child actions, driving consistency across sub-teams, brands and sites, including external manufacturing sites.
Provide guidance and leadership on change controls by providing coaching to teams and initiators utilizing available tools.
Identify opportunities for improvement.
Assist with management of Brand Testing Standards and strategies, with the objective of consistency and to avoid fragmentation in product release and market supply.
Foster compliance to GMPs and BMS Policies and Procedures.
Minimum of a Bachelor’s degree in a Natural Science, Pharmacy, Engineering, or other Healthcare-related field.
Minimum 8-10 years of experience in a technical, quality, and/or regulatory role within the biopharmaceutical industry with demonstrated leadership in Quality Management preferred.
Experience with change control and developing sound quality and compliance systems and processes.
Working knowledge and experience in Annual Product Quality Reviews
Demonstrated understanding of quality processes around post-approval change management.
Working knowledge of specification/method and change control quality systems.
Experience working with and/or supporting a matrix environment (i.e. Technical, Supply Chain and Regulatory functional areas).
Experience in Biologics and or Pharmaceutical operations, preferably with prior quality experience.
Demonstrated strategic thinking capability with strong project management skills and ability to focus on execution of strategic decisions.
Capable of building alignment across diverse perspectives and functional areas (e.g. Regulatory, MS&T, site Operations and Supply Chain).
Ability to work in a matrix environment and build strong relationships by being transparent, reliable and delivering on commitments.
Ability to lead a matrix team focused on execution of strategic quality projects.
Demonstrated leadership ability to provide innovative ideas, align and make decisions balancing speed, quality and risk.
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 email@example.com . Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Company: Bristol Myers Squibb
Req Number: R1552207
Updated: 2022-01-28 03:13:05.204 UTC
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
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