Senior Manager, External Manufacturing Biologics, Quality Operations Project Lead

Working with UsChallenging. 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.Position Purpose Act as Biologics & Steriles EXM Quality lead for assigned projects in BMS External Manufacturing network.Represent Bristol Myers Squibb (BMS) ExM Quality on process validation, scale-up or TT project teams. Carry out quality and compliance oversight and expertise. Advocate for compliance to cGMP and BMS requirements, and provide Quality input and guidance to stakeholders.Identify, assess, evaluate and escalate all significant quality risks and support adequate mitigation.Ensure successful transition of validated / approved process to commercial manufacturing.Lead improvements initiatives across CMOsDemonstrate proficiency in interpretation of FDA, EMA, Swiss and Rest of World cGMP and EU Good Distribution Practices (GDP) regulations for biologics drug substance, drug product and drug/device combination product manufacture, testing and distribution. Key ResponsibilitiesEnsure all quality deliverables related to manufacturing validation projects, scale-up, TT projects are issued timely with high quality - meet the quality standard and cGMP regulations set by applicable health authorities and BMS procedures.Partner with project stakeholders to jointly define goals, action plans and deliverables aimed at ensuring successful and compliant project execution.Ensure timely reporting and escalation of quality issuesEnsure Quality by Design (QbD) principles are implemented in all projects. Participate in facility/ process gap assessments and risk assessments on Bio manufacturing processes.Directly interface with CMO QA and project management regarding study plans, protocols and reportsInput, review, approve deviation, change control, batch documentation relevant to validation project.Work with CMOs, vendors and external analytical laboratories to evaluate their audit and inspection readiness and work with these groups to ensure that appropriate corrective actions are made in advance of audits/inspections to support BMS expectations and successful outcomesAssist with commercialization quality-related activities on the new products transferred or launched to/from CMOsProvide quality support during self-inspections, internal audits, and regulatory agency inspections at contract manufacturers.Escalate issues to senior management to ensure that issues are resolved to support BMS business and compliance requirementsRequired Qualifications and Desired ExperienceMinimum BS (M.Sc. Preferred) degree in relevant scientific discipline e.g. Biochemistry, Microbiology, Pharmacy, Chemistry, Biological Sciences or Related Pharmaceutical Science.Minimum of 8 years experience in (bio-)pharmaceutical operations.At least 4 years’ Quality Assurance experience in commercialExperience in contract manufacturingExperience with designing, leading or supporting process validation, scale-up, technical transfers of biologic and/or sterile product.Experience in pharmaceutical product manufacturing, with demonstrated expertise with one or more of the following: biologic drug substance or drug product manufacturing, aseptic drug product manufacturing, biologic combination productsHands-on experience and/or education in Microbiology/Hygiene and aseptic operations is highly desirable.Experience in supply chain ERP systems or SAP and Infinity/TrackwiseKey Competencies Good verbal, written, and presentation skills in English.Solid knowledge of US and international GMP requirements in clinical and commercial environmentsAbility to assess the right balance between quality decisions, technical considerations and business implications.Strong Excellent negotiation, communication and presentation skills across all levels both, internal and external to BMS.Demonstrated technical expertise in resolution of deviations, development of effective CAPA and use of risk assessments.Very good computer literacy, e.g. Microsoft Office SuiteAble to rapidly adapt to changing environment and circumstances requiring flexibility, tolerance, and great sense of urgency while assuring that all cGMP and regulatory requirements are met.Ability to negotiate and clearly present complex topics both written and verbally#LI-HybridIf 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 CareersWith 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 ProtocolPhysical 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.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 Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.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.