Senior Manager Quality Operations, Deputy RP/FvP

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Position Summary

The Senior Manager Quality Operations, Deputy of the 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 Deputy RP/FvP the incumbent deputizes the RP during absences to ensure that batches are technically/ GMP released/ traded and that compliance is achieved/ maintained 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).

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 manufactured under oversight of and traded by the Swiss Branch of Swords Laboratories 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
• Support 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 and approve ‘Ship on Test’ also known as ‘Shipment under Quarantine’ forms.
• undefined
• Decide on the final disposition of returned and rejected products
• Notifications to Management (NTM) and manage Product Defect Notifications including communication with Swissmedic (in collaboration with the RP, if available)
• Approve 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)
• Approve Swords Boudry related SOPs and other controlled documents, as required
• Approve APQRs, critical deviations and endorse Investigation Review Board (IRB) meeting outcomes
• Generally: deputize and cover all responsibilities listed in the current job description of the Associate Director Quality GMP/GDP, Responsible Person (RP,FvP)

Qualifications

• Master's or higher 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, and at least 1 year each in biotechnological, sterile manufacturing as well as distribution environments
• 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, German and/or French 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

If 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 Careers
With 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 a supportive culture, promoting global participation 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 Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

Supporting People with Disabilities

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 [email protected]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

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R1603613 : Senior Manager Quality Operations, Deputy RP/FvP