Senior Validation & Qualification Manager

Bristol Myers Squibb; Schweiz; On-site; CHF 140,000 - 190,000; Full time

Job summary

Bristol Myers Squibb in Switzerland seeks a Senior Manager of Qualification & Validation to lead the validation strategy for laboratory equipment, utilities, and computerized systems at the Boudry site. You will drive IQ/OQ/PQ programs and coordinate with QA to ensure compliant, timely project delivery.

This role requires strong leadership, a minimum of five years in validation/qualification, and effective collaboration with Health Authorities across GMP environments.

Qualifications

• Minimum 5 years directly relevant experience in Validation/Qualification (Equipment, HVAC and utilities, computer systems, manufacturing control systems and laboratory instrumentation in drug substance manufacturing).
• Previous managerial experience demonstrating leadership and staff development.
• Experience with Health Authority inspections, external audits and regulatory interactions.
• Excellent project management and technical writing skills.
• Working knowledge of GMP/cGMP regulations (FDA/EMA) for biologics manufacturing.

Responsibilities

• Lead the Validation/Qualification function for the BMS Boudry Manufacturing site and supporting Quality Control laboratories.
• Oversee IQ/OQ/PQ for laboratory equipment, utilities and validation of computerized systems.
• Develop and manage project plans, risk assessments, and execution of qualification/validation projects.
• Own the Site Validation Master Plan and ensure alignment with regulatory expectations.
• Serve as SME and primary contact for Health Authority inspectors and auditors.
• Collaborate with Manufacturing, Global Engineering, Quality Control and Quality teams.
• Ensure compliance with cGMPs, FDA, EMA regulations and internal guidelines.

Skills

Validation/Qualification

Project management

Team leadership

Regulatory compliance

Technical writing

Education

Bachelor of Science in Engineering

Tools

CMMS

GAMP

Job description

Bristol Myers Squibb in Switzerland seeks a Senior Manager of Qualification & Validation to lead the validation strategy for laboratory equipment, utilities, and computerized systems at the Boudry site. You will drive IQ/OQ/PQ programs and coordinate with QA to ensure compliant, timely project delivery.

This role requires strong leadership, a minimum of five years in validation/qualification, and effective collaboration with Health Authorities across GMP environments.