Senior Manager Quality Operations External Manufacturing Sterile and Biologics (f/m/d*)
Bei Bristol Myers Squibb lassen wir uns von einer einzigen Vision inspirieren - die Veränderung des Lebens von Patienten durch Wissenschaft. In den Bereichen Onkologie, Hämatologie, Immunologie und Herz-Kreislauf-Erkrankungen - und eine der vielfältigsten und vielversprechendsten Pipelines der Branche - trägt jeder unserer leidenschaftlichen Kollegen zu Innovationen bei, die bedeutende Veränderungen vorantreiben. Wir verleihen jeder Therapie, für die wir Pionierarbeit leisten, eine menschliche Note. Kommen Sie zu Bristol Myers Squibb und machen Sie einen Unterschied.
Bristol Myers Squibb (BMS) is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis. BMS also has one of the most reliable supply networks and our clinical operations program is among the best and busiest anywhere. We are a company that is forward thinking, a company in which diversity and inclusion are at the forefront of how we view our talent and how we work. Our science is second to none and the transformation work underway will enable us to continue to lead our peer group.
The Global Quality External Manufacturing is looking to recruit a permanent Senior Manager Quality Operations External Manufacturing Biologics for its operation based in Switzerland, reporting to the Director Quality Operations External Manufacturing Biologics. The Senior Manager Quality Operations External Manufacturing Biologics will lead the Quality Person-in-Plant team in Asia, ensure Quality oversight of a third-party biologics manufacturing site, ensure cGMPs are met during clinical and commercial production and be a part of and support the BMS virtual plant team in delivering product to patients on time.
Key responsibilities will include, but are not limited to:
- Interact with global and local stakeholders, exercise leadership in maintaining and monitoring compliance with worldwide regulatory requirements, current Good Manufacturing Practices (cGMPs), Good Distribution Practices (GDP), BMS Quality Management System and pertinent legal and / or business contract requirements
- Ensure timely Quality oversight, input and support to commercial and clinical production of biologic drug substance and drug product in a third party contract manufacturing organization (CMO)
- Account for timely review, provide input where required and approve CMO batch records as well as deviations, change requests, complaints, APQRs against established timelines
- Take responsibility for ensuring that the CMO batch release package meets requirements and is forwarded to the BMS responsible person in-time to support batch release as scheduled
- Prepare and present information about major investigations to senior management in BMS Review Boards
- Account for Quality input to technical transfer projects
- Facilitate clear, concise and regular communication with stakeholders, such as Virtual Plant Team, supervisor, technical and project teams
- Travel regularly, e.g. to Korea (approx. 4 times per year), to establish and maintain relationship with Person-in-Plant team as well as with CMO personnel
- Manage People: select and retain staff abroad in collaboration with HR Korea; accountable to match the right people with the right tasks. Develop and coach staff; provide feedback on performance/behavior against pre-defined goals and objectives
- Adequately use different electronic systems to document, report and summarize your work
Qualifications and Experience required:
- Minimum B.S. degree in Pharmacy, Chemistry, Biology, Chemical/Bio Engineering or equivalent, preferably experience with microbiology and aseptic operations
- Minimum of 7 years experience in biopharmaceutical operations, with at least 3 years in Quality Assurance, including hands-on experience in batch record review and product disposition
- Experience as a people manager, ideally also in a matrix organization, preferably including staff in Asia
- Demonstrated experience in Quality Systems and Quality Assurance including solid knowledge of cGMP (EU and US), GDP, ICH and other quality guidelines and standards, and ability to interpret and apply them for biologics drug substance and drug product manufacture and testing
- Technical expertise in conducting and leading investigations, developing effective CAPA and use of risk assessments
- Strong negotiation, communication and presentation skills across all levels both internal and external to BMS
- Fluency in English; good command of German
- Very good computer literacy (Microsoft Outlook, Word, Excel, PowerPoint) and experience in operating supply chain ERP systems or SAP and Veeva
Employees are expected to display the BMS behaviors which are: Passion, Innovation, Accountability, Urgency, Integrity and Inclusion, to enable them to be successful and perform at their highest level.
Join us and make a difference
At Bristol Myers Squibb, we’re creating innovative medicines for patients who are fighting serious diseases. We’re also nurturing our own team with inspiring work and challenging career options. No matter our role, each of us makes a contribution. And that makes all the difference.
We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.
*d stands for diverse, meaning that BMS welcomes every employee independent of gender, age, sexual orientation, ethnicity, religion
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.
Bristol Myers Squibb 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.