Associate Director Quality Operations > Joboolo CH :
Company : Bristol Myers Squibb Location : Boudry Neuchâtel From : Neuvoo CH
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Job Summary Working in a cross-functional virtual plant team this position provides quality oversight of Contract Manufacturing Organizations (CMOs) through effective collaboration with the other VPT functions.
Primary responsibility is to support management of CMO disposition documentation, assure CMO compliance with BMS and applicable cGMP and international regulatory standards for biologics drug substance and drug product manufacture, testing, and distribution.
Responsibilities:
In collaboration with Responsible Person and Qualified Person perform and oversight product disposition activities to ensure the timely supply of drug substance, drug product, and finished biological productsServe as a quality lead for the technical CMO projects related to commercial BMS productOwn or provide quality evaluation and approval of the change controls related to commercial biological products from CMOsProvide quality decision on the deviations reported by CMOs for manufactured BMS products.
Lead deviation meetings with CMOs.Prepare and review of Quality Agreements with external and internal manufacturing and testing partnersManage and report quality metrics in relation to CMO performanceReview and collaborate with CMO and BMS sites on Annual Product Quality Reviews as required for end-to-end product monitoringWork with CMOs to ensure commercialization and PAI readiness for biological products introduced to CMOsReview and approve analytical documentation in collaboration with the analytical SMEProvide quality operational support during self-inspections, internal audits, and regulatory agency inspections at contract manufacturers and BMS.Support supplier relationship manager, global procurement, supply chain and manufacturing science and technology teams for the projects, technical transfers programs, supplier selection programs, and commercial manufacturing activitiesReview validation documents, deviations, and change controls and escalate any potential compliance gapsEscalate issues to senior management to ensure that issues are resolved to support BMS business and compliance requirements in a timely mannerEvaluate external quality complaint investigations provided by CMOs Required Competencies:
Ability to assess the right balance between the business implications, technical considerations and quality decisionsAbility to set up and implement quality expectations for technical projects based on regulatory and industry standardsAbility to serve as a quality lead for technical projectsStrong negotiation, communication and presentation skills across all levels both internal and external to BMSDemonstrated technical expertise in resolution of deviations, complaints, development of effective corrective and preventive actins (CAPA) and use of risk assessmentsAble 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 metExcellent verbal, written and presentation skills in EnglishProficiency with the use of global systems (e.G.
SAP, Microsoft Office).Strong strategic and analytical thinking, problem solving and rapid decision making skillsDemonstrated capability in implementing challenging goals, objectives and practices in a complex and ambiguous environmentConfidence in negotiating and influencing without authorityProficiency in technical writing Required Qualification(s) and Desired ExperienceMinimum B.S.
degree in relevant scientific discipline e.G., Biochemistry, Microbiology, Pharmacy, Biological Sciences or Related Pharmaceutical ScienceMinimum of 10 years’ experience in aseptic or sterile manufacturing operations at the manufacturing site (manufacturing department, quality assurance and release, or manufacturing science/technology)At least 6 years in Quality Assurance, ideally in project management or product releaseExperience in biological product manufacturingExperience in contract manufacturingGood verbal, written and presentation skills in EnglishExperience with complex technical writing, ideally with authoring investigations, quality risk assessments, process descriptions, or study protocols Additional desired qualifications/experiences:
Ability to negotiate and clearly present complex topics both in written and verballyExperience with GMP tools and standard applications:
SAP, Trackwise or Verity, MS Office (esp.
OneNote, Visio) Wir setzen uns auf der ganzen Welt leidenschaftlich dafür ein, das Leben von Patienten mit schweren Krankheiten zu beeinflussen.
Unsere gemeinsamen Werte Leidenschaft, Innovation, Dringlichkeit, Verantwortlichkeit, Inklusion und Integrität befähigen uns, unsere individuellen Talente und unterschiedlichen Perspektiven in einer integrativen Kultur einzusetzen und bringen das höchste Potenzial jedes unserer Kollegen hervor.
BristolMyersSquibb weiß um die Bedeutung von Balance und Flexibilität im Arbeitsumfeld.
Wir bieten daher eine Vielzahl von attraktiven Benefits, Dienstleistungen und Programmen an, die unseren Mitarbeitern die Ressourcen bieten, ihre Ziele sowohl bei der Arbeit als auch in ihrem Privatleben zu verfolgen. BristolMyersSquibb BoudryNeuchâtel
