Director, Compliance And Quality System Biologics

Working with Us

Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

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. Read more careers.bms.com/working-with-us

Requirements and Knowledge

• Extensive knowledge of US and EMA GMP regulations and guidance.
• Strategic thinker with the ability to translate strategy into action with short, medium, and long terms plans.
• Strong background and demonstrated effectiveness in quality assurance operation and compliance of commercial biologics in an FDA and EMA regulated environment.
• Knowledge of computerized systems such as SAP, LIMS, Maximo, Trackwise, Syncade and DeltaV are desirable
• Proven experience in Inspection preparation and management is required.
• Works closely on resolution of critical issues that can impact supply continuity of critical medication to patients.
• Knowledge of biotech bulk and finished product manufacturing, analytical testing is highly desirable.
• Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry, a related discipline, or its equivalent.
• Experience in building and growing an organization is desirable.
• Expertise in ICHQ9 and Quality Risk Management Program Implementation is required.
• Demonstrated leadership, interpersonal, communication, and motivation skills.
• Strong project management capabilities to make plans, organizes tasks and work responsibilities to achieve objectives. Sets priorities. Schedules activities.
• A minimum of 10 years’ experience in biopharmaceutical quality or its equivalent with an additional 5-10 years of increasing management responsibility.

Responsibilities

Compliance

• Participates in Fact Finding Investigation and Fact Investigations Review Meetings
• Oversee the site self-inspection (internal audit) function to ensure that the site meets current health authority and BMS corporate requirements.
• Maintaining inspection readiness program for site personnel, including any periodic training and practice opportunities.
• Ensure that all process, change control documentation, Investigation reports related to manufacturing process and microbiology laboratory, and Annual Product Quality Review (APQR’s) elements are revised and approved.
• Prepare required health authority documentation as part of maintaining active GMP certification as well as support of new applications to new markets.
• Ensure a timely & effective deployment of the inspection readiness efforts in all aspects of cGMP to assure adherence to an Acceptable status of GMP/Quality/Regulatory Compliance requirements.
• Ensure Licenses renewals
• 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.
• Manages Biologic Product Deviation Reports (BPDR)
• Leads audits and Health Authority inspection preparation for the Bio-Sterile network, including the assistance in the generation of HA responses and CAPAs. Ensure that GMP follow up actions for audit/inspection observations are tracked and actioned as per current QMS (Quality Management System).
• Anticipates regulatory trend and establishes systems to minimize GMP compliance to the site and Company.
• Includes facilitation of BMS Global Regulatory Observation (GROe) program and BMS Policy/Directive review for site impact.

Quality Systems

• Oversee the Quality Risk Management program including owning the site risk register.
• Includes ensuring that our Documents and Records Management strategy meets all health authority requirements for Data Integrity.
• Oversee 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 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 Records Management program to ensure that documentation is available for use according to mutually defined service level agreement.
• Oversee the Change Control program to ensure that change requests are properly assessed for impact.
• Oversee the Training program to ensure that site colleagues have the training courses needed to perform GMP activities.

People Leadership

• Hires and develops qualified managers and staff.
• Proven ability to lead and motivate employees in all operational areas of the Company
• Leads staff to achieve professional growth and to attain established goals, develops remedial actions for staff whose performance does not meet standards and determines merit salary actions for the 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.

BMSBL

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers

With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

COVID-19 Information

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.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [email protected]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.