Director, Head of Quality Control

About the role

Bristol Myers Squibb is looking for a Director, Head of Quality Control for its laboratory in Boudry, Switzerland. The role covers the Quality Control organization of the laboratory, which handles commercial testing and acts as a centre of excellence for stability and new product introduction (late-stage development and launch). It reports to the site management and is responsible for developing and deploying the laboratory's strategy.

Key responsibilities

• Lead the site Quality Control organization, covering sample management, analytical testing and microbiology, and direct all functional accountabilities in line with policies and procedures.
• Oversee incoming raw materials, API, in-process samples, drug product, environmental monitoring, microbiology, stability and new product introduction testing, and set department objectives aligned with internal and global priorities.
• Oversee investigations of quality issues and recommend corrective and preventive actions and product disposition.
• Take part in production planning, prepare budgets, help with cost control, approve purchase orders, recommend capital expenditures and allocate human resources.
• Ensure review and approval of laboratory data and investigations follow cGMP and good documentation practices, and support review of QC standards and program documents.
• Participate in regulatory audits and coordinate between site stakeholders and laboratory management for commercial manufacture, release and new product introductions.
• Foster a well-trained, motivated staff, provide cGMP, SOPs, policy and safety training, mentor managers and run department meetings.
• Work with Human Resources on hiring, performance appraisals, personnel development and policy changes.
• Ensure a safe, healthy environment, comply with EHS rules, report incidents and near-misses, and take part in investigations.

Required profile

• University studies in chemistry, biochemistry, pharmacy or a related science; advanced degree preferred but not essential.
• 10 years of relevant work experience.
• Fluent in both French and English (written and spoken).

Required skills

• Excellent knowledge of cGMP and regulations applicable to Quality Control (EP, USP, JP).
• Advanced leadership skills, strategic thinking and ability to work in a matrix environment.
• Ability to write and present complex technical documents.