Quality Supplier Management Specialist

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.

Scope of the role

  • Assist with the quality support for the establishment, implementation and maintenance of Alliance Partnerships. This position will interact with key stakeholders to ascertain quality and business requirements.
  • 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.

Key responsibilities

The positions reports to the Supplier Management Lead, with job responsibilities that include but are not limited to:
  • Assistance with managing the Alliance Partnership Quality Agreement (QAG) life-cycle process(authoring, reviewing, drafting, negotiating, routing for approvals/signatures, archiving, amending/revising, and retiring) for BMS Partnerships including both PAR pharma products and Oral Solid Dosage Drug Products, in accordance with applicable cGMP regulations and BMS procedures.
  • Works with the Supplier Management Lead in Alliance Partnership for the use of drug products used in clinical trials. This includes the authoring, review and negotiation of all cGMP documentation.
  • Provide compliance and audit support for established partnerships as needed.
  • Assists the Supplier Management Lead as needed to ensure documentation associated with alliance partnerships are aligned and compliant with departmental procedures and cGMPs.
  • Coordinates the administration and maintenance of the Alliance Partnership Quality Agreement database/tracker.
  • Provide quality support and guidance to functional areas as needed
  • 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.
  • Provides advice and guidance to CSO and CMC 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.
  • Reviews and approves functional area procedural documents to ensure compliance with applicable regulations.
  • Leads continuous improvement initiatives and drives simplification of processes.
  • Ensures that Quality personnel have adequate training, education and experience to perform their job function effectively and updates training curricula.

Professional experience and qualifications

  • 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)
  • Excellent verbal and written communication skills
  • Strong Interpersonal and organizational skills

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.