Senior Quality Operations Manager, API Manufacturing
vor 3 Wochen
Bristol-Myers Squibb is seeking a highly skilled and experienced Senior Quality Operations Manager to join our team in Boudry, Switzerland. As a key member of our Quality Operations team, you will be responsible for leading the quality and compliance oversight management of third-party manufacturers engaged by External Manufacturing within a cross-functional team.
Key Responsibilities- Lead the quality and compliance oversight management of third-party manufacturers engaged by External Manufacturing within a cross-functional team.
- Ensure that the Quality resources working on priority Virtual Plant Teams (VPTs), or multiple VPTs are appropriate, effective, and coordinated.
- For specified products, lead a team to support the release activities in accordance with the conditions of our manufacturing authorization and provide strategic oversight on the API release process.
- Proactively manage contract manufacturer relationships from a quality and compliance perspective.
- Develop and manage the quality events, change control, and market complaints programs in respect of Third Party Manufacturer and Alliance Partnership relationships.
- Review process validation protocols and reports and also process verification/campaign reported for CMO's where relevant.
- Review and approval of process risk assessment, process verification reports for CMO's for intermediates and API. Support pre-approval inspections.
- Manage all activities associated with vendor approvals.
- Actively support the BMS Fact Finding Investigations (FIT) and Product Review Committee (PRC) processes for major investigations involving Third Party products. Prepare and present the information to senior management in support of the FIT/PRC processes.
- Provide quality/compliance subject matter expertise to the wider Supplier Relationship Management, Global Procurement, Supply Chain, QP, and MT teams in support of new projects, technical transfers programs, supplier selection programs, investigations, validation programs, market release, etc.
- Provide the requisite quality support to Global BMS functional groups such as Global Regulatory/CMC and the local country-based regulatory managers in support of regulatory filings, product renewals, regulatory agency questions, etc.
- Manage the quality metrics programs in relation to CMO performance.
- Serve as the Quality Operations leader in Technical Transfer projects and Manufacturing Launch Teams (MLTs) relating to Third Parties.
- Prepare, negotiate, and approve Quality Agreements and purchase specs with CMO's.
- Review and approve the Annual Product Reviews submitted by the CMO's. Support the Global BMS external auditing program by participation in audits of Third Parties as requested.
- Manage information/provide information for quality council meeting.
- Assess and implement corporate policies and directives.
- Select and retain Quality employees on VPTs.
- Allocate resources such that the right person is doing the right work at the right time.
- Review and approve goals and objectives for direct reports.
- Proactively develop and mentor staff.
- Seven to ten years' experience in the API 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 first-hand 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 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.
- Strong analytical and problem-solving skills.
- Minimum a BSc, preferably with a postgraduate qualification and minimum 7 years' experience in a GMP manufacturing environment. OpEx experience desirable.
-
Boudry District, Schweiz Bristol-Myers Squibb VollzeitTransforming Patients' Lives through ScienceBristol Myers Squibb is a company that is dedicated to transforming patients' lives through science. We are a global biopharmaceutical company that is passionate about discovering, developing, and delivering innovative medicines that make a meaningful difference in the lives of patients.Job SummaryWe are seeking a...
-
Associate Director, Quality Operations Global Api
vor 4 Wochen
Boudry, Schweiz Bristol-Myers Squibb Vollzeit**Working with Us** Challenging. 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...
-
Director, Quality Operations
vor 5 Monaten
Boudry, Schweiz Bristol Myers Squibb Vollzeit**Working with Us** Challenging. 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...
-
Quality Operations External Manufacturing Internship
vor 5 Monaten
Boudry, Schweiz Bristol-Myers Squibb Vollzeit**Working with Us** Challenging. 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...
-
Senior Quality Assurance Manager
vor 2 Monaten
Boudry District, Schweiz Bristol Myers Squibb VollzeitAbout the RoleWe are seeking a highly skilled and experienced Senior Manager to join our Cell Therapy team at Bristol Myers Squibb. As a key member of our External Quality Assurance team, you will be responsible for overseeing the operational activities related to external partners involved in Cell Therapy manufacturing.Key ResponsibilitiesOversee and...
-
Quality Assurance Specialist
vor 1 Monat
Boudry District, Schweiz Bristol Myers Squibb VollzeitAbout the RoleWe are seeking a highly skilled Quality Assurance Specialist to join our team in External Manufacturing. As a key member of our Quality Operations team, you will be responsible for ensuring the quality of our products and processes, and for maintaining compliance with regulatory requirements.Key ResponsibilitiesSupport the Quality Operations...
-
Quality Assurance Specialist
vor 1 Woche
Boudry District, Schweiz Bristol Myers Squibb VollzeitTransforming Patients' Lives through ScienceBristol Myers Squibb is a leading pharmaceutical company that is dedicated to transforming patients' lives through science. We are seeking a highly skilled and experienced Quality Assurance Specialist to join our team in External Manufacturing.About the RoleThis is a challenging and meaningful role that requires a...
-
Exm Bio/sterile Quality Operation Manager
vor 5 Monaten
Boudry, Schweiz Bristol-Myers Squibb Vollzeit**Working with Us** Challenging. 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...
-
Bulk Operations Operator
vor 2 Monaten
Boudry District, Schweiz Bristol Myers Squibb VollzeitJob SummaryThe Bulk Operations Operator will be responsible for manufacturing products (capsules and/or tablets) in compliance with GMP / cGMP regulations, health and safety rules, and quality system procedures.Key ResponsibilitiesCarry out basic production operations such as weighing materials and preparing powder mixtures in accordance with the training...
-
Boudry, Schweiz Bristol Myers Squibb VollzeitWorking with Us Challenging. 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...
-
Manager Quality Patient Operations
vor 2 Monaten
Boudry, Schweiz Bristol-Myers Squibb Vollzeit**Working with Us** Challenging. 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...
-
Manufacturing Operations Manager
vor 4 Wochen
Val-de-Travers District, Schweiz WuXi AppTec VollzeitJob SummaryThis position is a leadership role responsible for the direct management of individual contributors and/or supervisors and/or managers. As a key player in the product manufacturing process, this role will work closely with QA, QC, production, and logistics departments to ensure the highest standards of quality and health &...
-
Manufacturing Operations Manager
vor 1 Monat
Val-de-Travers District, Schweiz WuXi AppTec VollzeitJob SummaryThis role is a leadership position responsible for the direct management of individual contributors and/or supervisors and/or managers. As a key player in the product manufacturing process, this position will work closely with QA, QC, production, and logistics departments to ensure the highest standards of quality and health & safety are met.Key...
-
Manufacturing Operations Manager
vor 2 Wochen
Val-de-Travers District, Schweiz WuXi AppTec VollzeitJob SummaryThis position is a leadership role responsible for the direct management of individual contributors and/or supervisors and/or managers. As a key player in the product manufacturing process, this role will work closely with QA, QC, production, and logistics departments to ensure the highest standards of quality and health &...
-
Manufacturing Operations Manager
vor 1 Woche
Val-de-Travers District, Schweiz WuXi AppTec VollzeitJob SummaryThis position is a leadership role responsible for the direct management of individual contributors and/or supervisors and/or managers. As a key player in the product manufacturing process, this role will work closely with QA, QC, production, and logistics departments to ensure the highest standards of quality and health & safety are...
-
Boudry District, Schweiz Bristol Myers Squibb VollzeitJob SummaryBristol Myers Squibb is seeking a highly skilled Quality Assurance Manager to join our Cell Therapy team. As a Quality Assurance Manager, you will be responsible for providing quality oversight of Contract Manufacturing Organizations (CMOs) performing critical manufacturing steps for commercial and clinical CAR T products in Europe.Key...
-
Bulk Operations Operator
vor 4 Wochen
Boudry District, Schweiz Bristol Myers Squibb VollzeitTransforming Patients' Lives through ScienceBristol Myers Squibb is a leading pharmaceutical company dedicated to transforming patients' lives through science. We are seeking a highly skilled and motivated Bulk Operations Operator to join our team.Job SummaryThe Bulk Operations Operator will be responsible for manufacturing products in compliance with...
-
Boudry District, Schweiz Bristol Myers Squibb VollzeitJob SummaryWe are seeking a highly skilled Senior Manager to join our Cell Therapy QA team. As a key member of our organization, you will be responsible for overseeing the operational activities related to external partners involved in Cell Therapy manufacturing.Key ResponsibilitiesOversee and control operational tasks performed by external partners involved...
-
Boudry District, Schweiz Bristol Myers Squibb VollzeitJob SummaryWe are seeking a highly skilled Senior Manager to join our Cell Therapy QA team. As a key member of our organization, you will be responsible for overseeing the operational activities related to external partners involved in Cell Therapy manufacturing.Key ResponsibilitiesOversee and control operational tasks performed by external partners involved...
-
Senior Manager of Cell Therapy Manufacturing
vor 2 Monaten
Boudry District, Schweiz Bristol Myers Squibb VollzeitJob SummaryBristol Myers Squibb is seeking a highly skilled and experienced professional to join our team as a Senior Manager of Cell Therapy Manufacturing. This role will be responsible for supporting the production of personalized cell therapy products at Contract Manufacturing Organizations (CMOs) for both global clinical trials and commercial supply.Key...
