Associate Director, Quality Technical Operations

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.

Job Function

• Provide quality and compliance oversight and expertise to new product introduction (NPI) projects and technical transfer (TT) projects to, from and within Contract Manufacturing Organizations (CMOs) engaged by External Manufacturing operating in a cross-functional virtual team.
• Ensure NPI and TT project deliverables generated for assigned Non-Sterile, Sterile or Biological product stages - i.e. API/ BDS, Drug Product (DP) and/or finished product (FP) - meet the quality standard and cGMP regulations set by applicable health authorities and BMS policy & standards.
• Consistently demonstrate the BMS Core Behaviours.

Responsibilities

• Represent BMS external manufacturing (ExM) Quality on internal and external NPI or TT project teams - advocating for compliance to cGMP and BMS requirements, and providing Quality input and guidance to stakeholders
• Partner with project stakeholders to jointly define goals, action plans and deliverables aimed at ensuring successful and compliant NPI or TT of assigned products
• Work with CMO as the BMS Quality point of contact for NPI and TT activities between BMS and CMO
• Perform on-site visits at the CMO as required and agreed with project teams
• Ensure Quality by Design (QbD) principles are implemented for all new products at CMO's. Participate in facility/ process gap assessments and risk assessments on API/BDS/DP/FP manufacturing processes as part of technical transfers to CMO from BMS
• Perform QA review and approval of protocols and reports for assigned projects
• Support pre-approval inspections at CMOs
• Manage all QA activities associated with vendor selection/ initial approval
• Review and approve exceptions and changes from project protocols
• Serve as lead QA representative for change controls related to tech transfers and initial product launches
• Establish close working relationship with ExM Quality Analytical QC group for analytical method transfers associated with overall product/process tech transfers
• Perform assessments of incoming raw materials/starting materials with CMO and BMS SMEs. Make sure that raw materials and starting materials delivered from BMS to CMO complies with the BMS and CMO expectations
• Provide quality/compliance subject matter expertise to the wider Supplier Relationship Management, Global Procurement, Supply Chain and MS&T teams in support of new projects and technical transfers programs
• Serve as the ExM Quality representative on the appropriate BMS governance teams/projects (e.g. IDT, TPT, MLT) related to Tech Transfers to CMOs
• Assist with internal BMS quality projects if they relate to CMOs
• Support commercialization activities for the products technically transferred to or within CMOs to assure timely market launch and regulatory submission
• Escalate issues to BMS External Manufacturing Senior Management to ensure that issues are resolved to support BMS business and compliance requirements
• Assess and implement corporate policies, directives and global SOPs relevant for functional area

Required Competencies

• Minimum B.S. degree in relevant scientific discipline e.g. Biochemistry, Microbiology, Pharmacy, Biological Sciences or Related Pharmaceutical Science
• Minimum of 15 years' experience in pharmaceutical operations at a manufacturing site, including at least 5 years' experience in Quality Assurance.
• Solid knowledge of US and international GMP requirements in clinical and commercial environments
• Experience with designing, leading or supporting technical transfers of API, biologic and/or sterile product
• Experience in pharmaceutical product manufacturing, with demonstrated expertise with one or more of the following: APIs, biologic products, aseptic and/or sterile drug product manufacturing
• 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 build relationships, partnerships and influence and/or enforce quality decisions at external manufacturers
• Capability to reflect upon different opinions and make decisions as a team player
• Good verbal, written and presentation skills in English
• Experience with technical writing, ideally authoring investigations, quality risk assessments, process descriptions, or study protocols
• Ability to negotiate and clearly present complex topics both in writing and verbally
• Knowledge of combination products manufacturing or finished drug product packaging a plus
• Experience with pharmaceutical product testing methods/quality control
• Experience with standard IT applications: SAP or equivalent, electronic document approval, Veeva or Verity or equivalent, MS Office (esp. OneNote, Visio, PowerPoint)

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.