Director, Head of Quality Control

Bristol-Myers Squibb Co; Boudry; Vor Ort; CHF 180.000 - 240.000; Vollzeit

Zusammenfassung

Bristol Myers Squibb in Boudry, Switzerland, seeks a Head of Quality Control to lead the QC organization, including sampling, analytical testing and microbiology. The role focuses on strategic leadership, regulatory compliance, and integration within a global QC network to support commercial testing and product introductions.

The Head of QC will drive objectives, ensure training and staff development, and manage resource planning to sustain high-quality release of products across development and

Qualifikationen

• Extensive knowledge of cGMP and regulations applicable to QC (EP/USP/JP).
• Advanced leadership and ability to drive organizational changes.
• Experience with continuous improvement and lean laboratory projects.

Aufgaben

• Lead site Quality Control organization including Sample Management, Analytical Testing and Microbiology.
• Oversee all QC lab activities and ensure compliance with cGMP and documentation practices.
• Set objectives for the department aligned with internal and global priorities.
• Coordinate QA/QC activities for commercial manufacture and new product introductions.

Kenntnisse

Leadership

cGMP expertise

Regulatory awareness

Strategic thinking

Matrix teamwork

Ausbildung

University studies in chemistry/biochemistry/pharmacy

Advanced degree preferred

Jobbeschreibung

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.

This position is responsible for the Quality Control (QC) organization of the Bristol Myers Squibb laboratory in Boudry Switzerland. The scope includes incoming raw material, API, in-process samples, drug product, environmental monitoring, Microbiology, stability, new product introduction and investigation related testing. The Head of Quality Control is also accountable to establish and maintain connections within the QC network to be able to position the laboratory as part of the overall network. The scope of the laboratory is commercial testing, center of excellence for stability and the introduction of new products (late-stage development and launch). The Head of Quality Control is responsible to develop and deploy the strategy for the laboratory.

Duties/Responsibilities

• Lead site Quality Control organization including Sample Management, Analytical Testing and Microbiology.
• Direct all functional accountabilities for the Quality Control Laboratories of Boudry in accordance with organization’s policies and procedures.
• Oversee all aspects of the departments including incoming, analytical chemistry, microbiology, environmental monitoring, and the QC support team activities.
• Set objectives for the department which align with both internal and global priorities.
• Oversee the investigation of quality control related problems in environmental monitoring, raw materials, in-process, stability samples and drug product in order to develop appropriate corrective and preventive actions and to recommend disposition of products.
• Participate in production planning process, prepare budgets and contribute to cost control, approval of POs, recommend capital expenditures for technology and equipment, and allocate human resources to support manufacturing, testing, and investigations.
• Ensure that review and approval of laboratory data and investigations is performed accordance with cGMP’s and good documentation practices.
• Support review and approval of new and revised QC related standards and program documents to ensure compliance with cGMP’s.
• Participate in audits conducted by representatives of a regulatory agency.
• Coordinate between site stakeholders and laboratory management to ensure routine and non-routine activities of department support requirements for commercial manufacture and release of product as well as new product introductions.
• Collaborate with site management to ensure appropriate departmental support as priorities change employing principles of change management.
• Foster a well-trained, motivated and informed staff.
• Ensures all unit staff receive training in cGMP’s SOP’s, Company Policies and safety, and that employees meet defined qualification requirements for the position to which they are assigned.
• Mentors Managers provides development plans and mentoring to members of the department.
• Conduct department meetings.
• Work closely with Human Resources on Policy changes, interpretation, and execution, Hiring of new employees, Employee disciplinary action, Performance Appraisals and Personnel Development.
• Provide a safe and healthy work environment for their staff in areas under their control and ensures compliance with relevant rules and legislation in those areas.
• Work closely with EHS to evaluate hazards and perform risk analysis.
• Ensure that staff (including short duration and temporary contractors) are properly informed of hazards and trained to act in an appropriate way.
• Promote safe practices and behaviors, verify that EHS rules are implemented and respected.
• Report immediately all incidents and near-misses to EHS, participate in investigations, and identify preventive measures to prevent similar accidents in the future.
• Performs other tasks as assigned.

Qualifications Specific Knowledge, Skills, Abilities:

• Excellent knowledge of cGMP and regulations applicable to the Quality Control environment (EP, USP, JP).
• Advanced leadership skills.
• Drive organizational changes.
• Drive continuous improvement and lean laboratory projects.
• Requires strategic thinking and ability to work in a matrix environment.
• Ability to interpret/write general, technical, and complex business documents.
• Advanced presentation with development and delivery skills Fluent in both French and English Written and speaking - Mandatory Education/Experience/ Licenses/Certifications: University studies in chemistry, biochemistry, pharmacy, or related science.
• Advanced degree preferred but not essential.
• 10 years’ relevant work experience required.

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 [e-mail]. 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

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

We’re creating innovative medicines for patients fighting serious diseases. We’re also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.