At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.
The Senior Manager Quality Operations, Delegate RP/FvP will be responsible to support the Responsible Person (RP)/ Fachtechnisch verantwortliche Person (FvP) for the direct supervision, maintenance and continuous development of the Quality Management System in order to ensure that the manufacturing and trading operations are performed in compliance with Swiss and international guidelines on current Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP), thus ensuring the safety, efficacy and quality of the medicinal products, and that non-ready-to-use and ready-to-use medicinal products are manufactured and/or traded in a safe manner.
As the Delegate RP/FvP the incumbent supports the RP/FvP and will technically release batches in compliance with all relevant applicable national and international GMP and GDP regulations issued by the relevant authorities as well as with BMS internal guidelines and its Quality Management System (QMS).
The ultimate responsibility for the safety, efficacy and quality of the medicines and adherence to the legal obligations and standards lies with the RP/FvP.
Duties/Responsibilities
- Maintain and continuously improve the companies’ Quality Management System to ensure compliance with the legal requirements at any time
- Has the authority to issue directives within the area of responsibility
- Ensure that the medicinal products externally manufactured under oversight of and traded by the Boudry Branch of Swords Laboratories Unlimited Company meet the specifications in force and are being manufactured in accordance with Good Manufacturing Practice (GMP) as well as traded/ transported in accordance with Good Distribution Practice (GDP) requirements
- Ensure that any additional requirements imposed on certain products by national law are adhered to
- Perform supplier and customer bona fide checks to ensure that all parties involved in the manufacture, supply, storage or distribution of the medicinal products are authorized to carry out the operations that they perform
- Perform supplier qualification and Approved Supplier List activities
- Support the coordination and execution of any recall operations for medicinal products under Swords Boudry oversight
- Support or lead self-inspections that are performed at appropriate, regular intervals following a prearranged program and the implementation of any necessary corrective measures if required
- Author and/ or review SOPs and other controlled documents in conjunction with the technical/ GMP batch release of the medicinal products and in the area of responsibility
- Manage, support or investigate relevant customer/ technical complaints if required
- Apply Quality Risk Management principles for the assessment, control, communication and review of risks to the quality of the manufactured and traded products; perform risk assessment as required
- Raise, manage, approve and/ or investigate deviations (including transport deviations) to ensure they are documented and investigated, and appropriate corrective and preventive actions (CAPAs) are implemented in line with the principles of quality risk management
- Collate KPIs and data for reviewing and evaluating the effectiveness of the Quality Management System on a periodic basis
- Support local Health Authority Inspections and Global BMS Audits including their preparation and coordination; support related follow up activities and supervise CAPA implementation in collaboration with the RP/FvP
- Participate regularly in a course, seminar, congress or the like with focus on GMP/GDP topics regarding regulatory requirements, trends and industry standards as part of the continuous professional development
- Lead and/or participate in site and multi-site projects involving quality matters of Swords Boudry
- Participate in plant visits at Contract Manufacturing Organization
- Lead and/or manage qualification/validation activities involving Swords Boudry GMP/GDP operations, systems or software
- Perform technical/ GMP release and transfer to saleable stock of non-ready to use and ready to use medicinal products for further processing independently from management and commercial functions
- Approve product redeployments and direct shipments
- Author, review quality agreements with third parties and internal sites covering outsourced/ delegated activities, including, but not limited to, manufacturing, testing, release, storage, and transportation services as well as supply to customers (markets)
- Issue Notifications to Management (NTM)
- Responsible for the maintenance and approval of quality related master data in SAP
- Report quality issues and any suspicion of illegal trading to RP/FvP and support the notification of Swissmedic according the applicable requirements and within the stipulated deadlines
- Maintain up-to-date product and supply chain knowledge for all products technically released
- Manage ‘Ship on Test’ also known as ‘Shipment under Quarantine’ forms.
Qualifications
- Degree in Pharmacy, Chemistry, Biology, Chemical/ Bio Engineering or equivalent
- Master's or higher degree - minimum of 5 years' or Bachelor’s degree -minimum 7 years’ experience in the pharmaceutical industry, with solid quality and compliance experience
- Experience in the application of pharmaceutical Quality Systems and Quality Assurance including solid knowledge of current Good Manufacturing Practices (cGMP) (European Union (EU) and United States (US)), EU GDPs, PIC/S, International Council for Harmonisation (ICH) and other quality guidelines and standards, and ability to interpret and apply them during daily work
- Previous experience as Responsible Person (FvP), including hands-on experience in batch review and release is strongly preferred
- Technical expertise in conducting investigations, developing effective CAPAs and use of risk assessment techniques
- Experience in applying Quality Risk Management principles and tools
- Strong interpersonal communication (both verbally and in writing), collaborative and leadership skills in a matrix organization and in a variety of cultures
- Fluency in English. Additionally, French and/or German are preferred
- Experience in working with SAP, Veeva and electronic Document Management Systems
- Very good computer literacy (Word, Excel, PowerPoint, Microsoft Outlook)
- Strong strategic and analytical thinking, problem solving and rapid decision-making skills
- Execute challenging goals and objectives in a highly regulated, complex and dynamic environment
- Strong ability in negotiating and influencing without direct supervising authority in complex, high impact situations
- Ability to be decisive and influence management with demonstrated leadership skills to drive change in a compliance culture
- Demonstrated ability in technical writing, computer knowledge and communication skills
- Clear presentation and communication skills both, oral and written
- Trustworthiness
We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.
How We Work
Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.
Supporting People with Disabilities
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R1607188 : Senior Manager Quality Operations, Delegate RP/FvP