Senior Manager Quality Operations, Deputy RP/FvP

Bristol Myers Squibb seeks a Senior Manager for Quality Operations in Boudry, Switzerland. This hybrid role supports the Responsible Person in maintaining GMP/GDP compliance and overseeing quality systems.

This position serves as a key support to the Responsible Person (RP) or Fachtechnisch verantwortliche Person (FvP). The incumbent is tasked with the direct supervision, upkeep, and ongoing enhancement of the Quality Management System. Additionally, the role ensures that all manufacturing and trading activities adhere to Swiss and international Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) standards. In the absence of the RP, the incumbent acts as the deputy, maintaining batch release authority and ensuring continuous regulatory compliance.

Responsibilities

• Oversee the maintenance and continuous improvement of the Quality Management System to guarantee legal adherence.
• Verify that medicinal products meet all specifications and are produced or distributed in strict accordance with GMP and GDP regulations.
• Conduct due diligence checks on suppliers and customers to confirm their bona fide status.
• Manage supplier qualification processes and maintain the Approved Supplier List.
• Assist in the coordination and execution of product recall operations.
• Lead or support self-inspections and ensure the implementation of necessary corrective actions.
• Draft, review, and approve Standard Operating Procedures (SOPs) and other controlled documentation.
• Handle, support, or investigate technical and customer complaints.
• Apply Quality Risk Management principles to assess and mitigate risks.
• Initiate, manage, and investigate deviations, including the implementation of Corrective and Preventive Actions (CAPAs).
• Gather and analyze Key Performance Indicators (KPIs) to evaluate the effectiveness of the QMS.
• Facilitate local Health Authority inspections and global Bristol Myers Squibb audits.
• Lead or participate in site-specific and multi-site projects related to quality matters.
• Execute technical and GMP release processes, transferring products to saleable stock.
• Approve product redeployments and direct shipments.
• Draft, review, and approve quality agreements with third parties and internal sites.
• Maintain and approve quality-related master data within SAP.
• Report quality issues and suspected illegal trading to the RP/FvP and support notifications to Swissmedic.
• Manage and approve 'Ship on Test' documentation.
• Determine the final disposition of returned or rejected products.
• Oversee Product Defect Notifications and communicate directly with Swissmedic.
• Approve Annual Product Quality Reviews (APQRs), critical deviations, and endorse outcomes from the Investigational Review Board (IRB) meetings.

Requirements

• Master's degree or higher in Pharmacy, Chemistry, Biology, Chemical Engineering, or Bioengineering, or an equivalent qualification.
• At least five years of experience in the pharmaceutical industry with a Master's degree, or seven years with a Bachelor's degree.
• Minimum of one year of experience in biotechnological manufacturing, sterile manufacturing, and distribution environments.
• Demonstrated solid experience in quality assurance and regulatory compliance.
• Comprehensive knowledge of cGMP (EU and US), EU GDPs, PIC/S, ICH guidelines, and other relevant quality standards.
• Fluent proficiency in English.

Nice to have

• Prior experience serving as a Responsible Person (FvP) with hands-on involvement in batch review and release.
• Proficiency in German and/or French.

What the company offers

• A diverse range of competitive benefits, services, and employee programs.
• A work environment that emphasizes balance and flexibility.
• Opportunities for professional growth and collaboration with high-achieving teams.
• A supportive culture that encourages global participation in clinical trials.

About the company

Bristol Myers Squibb is driven by a mission to transform patients' lives through scientific innovation. The organization fosters a culture built on shared values such as passion, innovation, urgency, accountability, inclusion, and integrity. The company is also committed to ensuring that people with disabilities can excel, supported by transparent recruitment practices and necessary accommodations.

• Mission-focused: Transforming patients' lives through science.
• Core values: Passion, innovation, urgency, accountability, inclusion, and integrity.
• Inclusive environment: Dedicated to enabling people with disabilities to excel through transparent recruitment and accommodations.