Senior Manager Quality Operations, Delegate RP/FvP

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

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  adastaffingsupport@bms.com . Visit  careers.bms.com/eeo-accessibility  to access our complete Equal Employment Opportunity statement.

Candidate Rights

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

For roles based in Los Angeles County only:  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/

Data Protection

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Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If this posting is missing required information required by local law or incorrect, contact BMS at  TAEnablement@bms.com with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.

R1607188 : Senior Manager Quality Operations, Delegate RP/FvP