Drug Product (DP) Fleet Lead

Roche seeks a Drug Product Fleet Lead in Basel to drive global manufacturing standardization, manage multi-year Capex strategies, and ensure regulatory compliance for DP equipment lifecycle.

This position sits within Pharma Technical Operations, specifically under PT Global MSAT, Engineering and Sustainability. The incumbent acts as the single point of ownership for the Drug Product component of the Global Manufacturing Standardization Strategy, reporting directly to the Global Fleet Program Owner. The primary purpose is to oversee the end-to-end development, implementation, and operational management of standardized manufacturing systems across the global Drug Product network.

Responsibilities

• Develop and maintain the multi-year global strategy and roadmap for the Drug Product Fleet concept and associated systems.
• Guarantee that Drug Product fleet equipment and systems remain equivalent throughout their entire lifecycle.
• Present and manage the global operating budget, including CAPEX and OPEX, for the deployment and maintenance of DP fleet systems.
• Lead interactions with health authorities, including Pre-Approval Inspections (PAIs) and major regulatory filings.
• Ensure all DP fleet equipment complies with global documents such as User Requirement Specifications (URS) and functional specifications.
• Own and maintain DP-specific lifecycle deliverables, including the Master Fleet Validation Master Plan (FVMP) and Fleet Standard Operating Procedures (SOPs).
• Conduct and oversee side-by-side comparative analyses of GMP-critical and process-critical aspects for DP equipment.
• Oversee continuous monitoring of DP fleet performance, tracking critical process parameters (CPPs) and critical quality attributes (CQAs).
• Assess unplanned events or discrepancies impacting DP equipment for network-wide impact.

Requirements

• Master’s degree in Engineering (Chemical, Mechanical, Bioengineering), Life Sciences, or a related technical field.
• Minimum of 15 years of experience in the pharmaceutical/biotech industry.
• Strong emphasis on Drug Product manufacturing and multi-site operations at a global scale.
• Strong understanding of GMP, Quality Systems (PQS), and regulatory requirements such as ICH Q10 and ICH Q12.
• Demonstrated expertise in managing the lifecycle of complex DP manufacturing equipment, from procurement to decommissioning.
• Strong track record of leading change management processes in a highly regulated environment.

Nice to have

• PhD is strongly preferred.

About the company

Roche is a global healthcare company dedicated to advancing science to improve people's lives. With a mission to prevent, stop, and cure diseases while ensuring everyone has access to healthcare, the company empowers employees to explore new possibilities and foster creativity. More than 100,000 employees across the globe are dedicated to this mission, working in a culture that encourages personal expression, open dialogue, and genuine connections. Employees are valued, accepted, and respected for who they are.

• The culture encourages personal expression, open dialogue, and genuine connections.
• Employees are valued, accepted, and respected for who they are.
• The mission is to prevent, stop and cure diseases and ensure everyone has access to healthcare.
• More than 100,000 employees across the globe are dedicated to advance science.
• The company empowers employees to explore new possibilities and foster creativity.