Drug Product (DP) Fleet Lead

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The Position

As an integral part of Pharma Technical Operations (PT), PT Global MSAT, Engineering and Sustainability (PTT)  plays a key role in seamlessly leading global Capex projects from planning through execution by providing strong project management, technical expertise and project performance on time and on budget. Proactive maintenance, facility fitness and equipment support for the manufacturing network are adding to the mandate of PTT being PT`s powerhouse for technical product health. 

The Drug Product (DP) Fleet Lead is a critical leadership role responsible for the end-to-end development, implementation, and operational management of standardized manufacturing systems across the Drug Product network. Reporting to the Global Fleet Program Owner, this role owns the development of the Drug Product Fleet concept, ensuring the "design one, build many" philosophy is executed to drive cross-site equivalency and unparalleled efficiencies.

The Opportunity

You serve as the enterprise-wide single point of ownership for the Drug Product aspect of the Global Manufacturing Standardization Strategy, accountable for its success across the network, and you own and drive the development of the Drug Product Fleet concept, establishing the specific standards for DP manufacturing systems to be deployed across the global network. Your main responsibilities are

• Define, own, and drive the multi-year global strategy and roadmap for the Drug Product Fleet concept and systems together with gMSAT Drug Product and the DP manufacturing sites and serve as the primary point of accountability for all DP-specific fleet systems, ensuring they meet the defined global standards for the production network. Hold ultimate accountability for ensuring and maintaining the equivalency of DP fleet equipment & systems throughout their entire lifecycle.

• Present the global operating budget (CAPEX and OPEX) and resource allocation for DP fleet system deployment and maintenance across the network.

• Lead and act as the primary point of contact (POC) for all outward-facing health authority interactions and inquiries (including leading Pre-Approval Inspections (PAIs) and major regulatory filings) that specifically concern Drug Product fleet systems.

• Ensure DP fleet equipment adheres strictly to global documents, including User Requirements Specifications (URS) and functional specifications. Own and maintain DP-specific lifecycle deliverables, including the Master Fleet Validation Master Plan (FVMP), Fleet SOPs, and URS and lead the analysis of proposed changes on DP fleet equivalency, ensuring consistent implementation across all affected DP sites.

• Conduct and oversee side-by-side comparative analyses of GMP-critical and process-critical aspects for DP equipment. Oversee the continuous monitoring of DP fleet performance, tracking critical process parameters (CPPs) and critical quality attributes (CQAs).

• Ensure that unplanned events or discrepancies impacting DP equipment are assessed for network-wide impact in collaboration with key stakeholders.

Who you are

You have a strong track record of leading change management processes in a highly regulated environment with a focus on cross-site impact and you bring the following qualifications:

• Master’s degree in Engineering (Chemical, Mechanical, Bioengineering), Life Sciences, or a related technical field; PhD is strongly preferred.

• A minimum of 15 years of experience in the pharmaceutical/biotech industry, with a 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.

• Proven ability to drive alignment and decision-making across diverse functional groups and geographical locations.

Ready to take the next step? We'd love to hear from you. Apply now to explore this exciting opportunity!

Who we are

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.