Senior Manager, Quality Control, Site Instrumentation and Capability

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

The BMS site of Boudry is a Manufacturing Site for Oral Solid Dosage Drugs and a Center of Excellence for New Product Introductions, relying on agile and flexible manufacturing and testing operations. The QC department of BMS Boudry, Switzerland is responsible for testing raw materials, drug substance (API) and drug product (Bulk) for oral solid dosage forms manufactured at the site and supporting New Product Introductions. It is also a Centre of Excellence for testing of Stability samples.

This position will be key to developing QC Capabilities and Operational Excellence to welcome New Products at the site through late-stage product development and launch while sustaining performance of routine testing operations for commercial products and stabilities.

The Senior Manager QC Site Instrumentation and Capability is responsible for overseeing QC site-focused activities related to instruments and associated software, for leading the QC learning program, and for driving laboratory Operational Excellence projects and initiatives.

You will be expected to work cross-functionally with internal stakeholders such as QC Management, Project Management Office and Validation and to act as a business partner with global functions including Analytical Science & Technology and Network QC to anticipate and drive site instrumentation needs planning, model selection and implementation strategy, oversee instrument lifecycle activities, developing site subject matter expertise and leading resolution of instrument reliability issues.

Also, you will be expected to drive the redesign and implementation of a QC onboarding and learning program including apprentice and analysts training and qualification.

Finally, the Senior Manager Site Instrumentation and Capability will drive implementation and sustainability of QC operational excellence initiatives such as Lean Lab, Inspection-Readiness, Instrument Reliability.

As a Senior Leader of the Quality Control organization act as a deputy for the Head of QC in his/her absence and for Managers of other Quality Control areas.

Skills/Knowledge Required

• Bachelor’s degree in Analytical Chemistry, Biochemistry, Pharmacy, or other Life Science.
• At least 8 years of experience in a GMP-regulated environment and at least 3 years of experience managing Laboratory Operations.
• Proven experience in managing direct reports.
• Strategic thinking and influencing skills.
• Proven experience in leading Operational Excellence initiatives.
• Proficient with problem-solving and investigation tools.
• Proficient with risk assessment methodologies and facilitation.
• Advanced knowledge of equipment qualification requirements and Data Integrity principles.
• Effective verbal communication skills, technical writing, and presentation skills.
• Experienced with regulatory inspections and audits, able to present and defend complex topics as Subject Matter Expert.
• Fluent in English and professional command of French (written and verbal).

Duties and Responsibilities

Manages QC Site Instrumentation and Capability team and ensures cGMP compliance of the operations under their responsibility.

• Sets priorities in line with business needs.
• Identifies development needs and opportunities through training and project assignments.
• Ensures assigned personnel are qualified on appropriate operating procedures, training modules, GMP requirements and regulatory standards.
• Provides coaching to QC Scientists and QC Staff leading or supporting complex investigations, change controls, risk assessments and remediations.
• Provides a safe and healthy work environment for their staff and ensures compliance with relevant rules and legislation.

Oversees QC site-focused activities related to instruments and associated software

• Represents site QC operations as business partner for site instrumentation needs planning and model/software application selection.
• Oversees site QC evaluations and remediation strategies to transition and conform to the Global BMS Data Integrity, Equipment and Computer System Validation requirements.
• Represents site QC in Global projects and deployment of Enterprise systems.
• Ensures timely execution of qualification activities and instrument lifecycle activities owned by QC.

Drives the redesign and implementation of the site QC learning program in conformance with Global training procedures and Learning Management System.

• Analyst onboarding and qualification program
• Apprentice training program
• Continuous development of subject matter expertise and capabilities within QC.

Drives implementation and sustainability of operational excellence initiatives within QC.

• Inspection Readiness, Gemba, 5S, reliability and error-reduction.
• Efficiency and Cost reduction initiatives.
• Promotes interactions with other business units and QC sites through community of practices to address issues affecting the laboratory, harmonize practices and procedures and share expertise.

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.