Manager, Supplier Quality (R1560860-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 Supplier Quality Manager will assist with the quality oversight for all activities pertaining to raw materials and components used in Investigational Medicinal Products to ensure the standards of BMS and regulatory agencies (FDA, EU, etc) are met including release and change notifications.
Responsible for timely release of raw materials, components, and comparators.
Assists in the management of change notification and complaints from suppliers to conform cGMPs.
Ensures compliance to applicable Quality Policies, Directives, SOPs, FDA and EU guidance and cGMPs.
Manages and maintains the Product Development Approved Vendor List.
Works closely with the Global Audit Team and stakeholders to ensure accuracy of vendor status.
Aids in the authoring/reviewing procedural departmental documents as needed.
Reviews and approves functional area procedural documents to ensure compliance with applicable regulations.
Provides advice and guidance to functional areas within the organization with respect to matters of quality and regulatory compliance.
Monitors delegated activities associated with material, component and comparator release, the review of related documentation to ensure conformance to cGMP, BMS requirements, and government regulations.
Coordinates review and approval of all quality incidents/deviations and manages timely implementation of needed CAPAs.
Provides input into the implementation of cGMP regulations and corporate policies and procedures.
Participates in regulatory cGMP inspections and third party inspections as needed.
Knowledge of science generally attained through studies resulting in a B.S., in chemistry, pharmacy or biology or a related pharmaceutical science.
Minimum of 3-5 years’ experience in pharmaceutical quality.
Demonstrated effectiveness in quality assurance operation and compliance of clinical drug product and supplier management in a FDA and EMA regulated environment.
Demonstrated proficiency in interpretation of FDA and EMA cGMP regulations as they apply to clinical supplies.
Experience in R&D environment is highly desirable.
Demonstrated leadership, interpersonal, communication, and motivation skills.
Ability to provide innovative, compliant ideas or alternate approaches which create value.
Ability to work on multiple quality agreements/projects/initiatives at any given time.
Highly collaborative, possess a track record of building and maintaining cross-functional relationships, and able to communicate effectively.
Demonstrates excellent attention to detail, and ability to consistently meet high standards of quality required in QA Compliance.
Demonstrates knowledge and experience in cGMP regulations.
Proficient in Desktop Publications (MS Word/Excel/PowerPoint/SharePoint).
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.
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