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Associate Director Compliance and Quality Systems

Bristol-Myers Squibb Company

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Devens, MA
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Job Description

As posted by the hiring company

Job Overview:

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.

Associate Director, Compliance and Quality System

Summary:

To oversee quality compliance activities relative to internal and external health authority requirements and Quality System activities including internal audits, change management, supplier audits, records management, and training at the Devens site.

Responsibilities:

Compliance

  • Facilitates all health authority inspections and BMS internal audits, including planning, execution, and follow-up. Includes on-site inspections as well as remote (aka desktop) audits.

  • Maintaining inspection readiness program for site personnel, including any periodic training and practice opportunities.

  • Includes facilitation of BMS Global Regulatory Observation (GROe) program and BMS Policy/Directive review for site impact.

  • Prepare required health authority documentation as part of maintaining active GMP certification as well as support of new applications to new markets.

  • Oversee the site self-inspection (internal audit) function to ensure that the site meets current health authority and BMS corporate requirements.

  • Manages and provided Quality Review of Annual Product Quality Review Report elements as established in products / systems schedule.

Quality Systems

  • Facilitates the Devens Site Quality Council by developing and monitoring the scorecard of key metrics, as well as the Site Quality Plan of key continuous improvement and emerging topics.

  • Oversee the Quality Risk Management program including owning the site risk register.

  • Oversee the Change Control program to ensure that change requests are properly assessed for impact.

  • Oversee the Supplier Quality program to ensure that suppliers and materials are fit for use in GMP manufacturing, which includes material and supplier qualification, as well as oversight of life cycle activities such as supplier audits/agreements, complaints/investigations and change notification.

  • Oversee the Training program to ensure that site colleagues have the training courses needed to perform GMP activities.

  • Oversee the Records Management program to ensure that documentation is available for use according to mutually defined service level agreement.

  • Includes ensuring that our Documents and Records Management strategy meets all health authority requirements for Data Integrity.

People Leadership

  • Hires and develops qualified managers and staff.

  • Ensures that staff have adequate training, education, and experience to perform their GMP related job function effectively.

  • Oversee budget adherence to department cost center.

Requirements:

  • Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry, a related discipline, or its equivalent.

  • A minimum of 7 years’ experience in biopharmaceutical quality or its equivalent with an additional 6 to 10 years of increasing management responsibility.

  • Experience in building and growing an organization is desirable.

  • Expertise in ICHQ9 and Quality Risk Management Program Implementation is required.

  • Strong background and demonstrated effectiveness in quality assurance operation and compliance of commercial biologics in an FDA and EMA regulated environment.

  • Knowledge of biotech bulk and finished product manufacturing, analytical testing is highly desirable.

  • Extensive knowledge of US and EMA GMP regulations and guidance.

  • Proven experience in Inspection preparation and management is required.

  • Demonstrated leadership, interpersonal, communication, and motivation skills.

  • Knowledge of computerized systems such as SAP, LIMS, Maximo, Trackwise, Syncade and DeltaV are desirable

BMSBL, BMSBLDMA, VETERAN

#LI-Onsite

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 adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

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