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Senior Director, EXM Quality Bio Sterile GCH

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Senior Director, EXM Quality Bio Sterile GCH

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.

Provides Quality leadership to the GCH European and Asia Pacific External Manufacturing Virtual Plant teams for Drug Product and Packaging and manages the ExM Quality department with responsibilities for quality assurance (including product disposition), documentation and compliance. Ensures that External Manufacturers adhere to BMS Quality standards and regulatory requirements and products are manufactured, tested and released to these standards/requirements. Serves as the most Sr. Quality leader in Boudry for ExM inspections, registrations, etc.

Responsabilities :

Manage Operations
  • Responsible and accountable for the Quality Operations within the GCH Virtual Plants (as defined):
  • Product disposition
  • Change Control Management and approval
  • Annual Product Quality Review publication and approval
  • Deviation management and approval (including laboratory out-of-specification results)
  • Quality risk management
  • Quality Council
  • Quality Agreement development, negotiation and maintenance
  • Complaint management
  • Quality Metrics management
  • SOP management
  • Provide support to External Manufacturers during Regulatory / Health Authority inspections and customer audits.
  • Assist with preparation of audit observation responses.
  • Provide support during process and analytical technical transfers to external manufactures.
  • Provide support to BMS Business Development for product divestiture activities.
  • Provide support to BMS Procurement throughout the supplier selection process.
  • Provide support for the authoring and review of CMC sections of regulatory filings.
  • Serve as Global Quality lead and point-of-contact for Manufacturing Launch Teams.
  • Ensure External Manufacturers are PAI ready and liaise with GQA in preparation of activities.
  • Review supply agreements and associated contracts.
  • Lead Fact Finding, PRC and PAC events related to products manufactured at External Manufacturers.
  • Accountable for the issuance of NDA Field Alert Reports, Quality Defect Notifications, etc. for products within scope.
  • Responsible for Quality oversight of GMP Warehouse locations that ExM Supply Chain manages.
Manage People
  • Selects and retains staff.
  • Accountable for allocating resources such that the right person is doing the right work at the right time.
  • Develops and mentors staff.
  • Provides feedback on performance against predefined objectives.
Manages Finance
  • Defines departmental budget requirements and achieves budget objectives for the year.
  • Responsible for oversight of >$100MM annual spend.
Required Competencies
  • B.S. in sciences or pharmaceutical-related field, Advanced degree preferred.
  • Minimum of 12 years leadership experience in the pharmaceutical industry, preferably in Quality, Manufacturing Technology, Regulatory or a position within a Health Authority Agency.
  • Extensive experience and technical knowledge in chemical, biological and/or pharmaceutical operations which enables firsthand knowledge of manufacturing, quality control, quality assurance, regulatory affairs/sciences and interface with research & development
  • In depth knowledge of cGMP regulations pertinent to the USA, EU and other international markets
  • Direct experience interacting with Health Authorities and managing Health Authority inspections, specifically FDA and/or EMA.
  • Direct experience in interacting with external manufacturers and managing quality at external manufacturing sites.
  • Ability to assess the right balance between business targets and scientific and quality decisions.
  • Ability to understand the business implications regarding quality positions and decisions.
  • Ability to build relationships, partnerships and influence and/or enforce quality decisions at external manufacturers.
  • Strong negotiation, communication and presentation skills across all levels both internal and external to BMS.

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.

Adresse

Route de Perreux 1 2017 Boudry

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