Roche
pharmaceuticaliotech
DrugProduct(DP)FleetLead
“Drug Product (DP) Fleet Lead at Roche. Skills: Drug Product Fleet concept, manufacturing systems, cross-site equivalency. Define, own, and drive global strategy and roadmap for Drug Product Fleet concept. Serve as primary point of accountability for DP-specific fleet systems”
What You'll Achieve.
seamlessly leading global Capex projects from planning through execution; providing project performance on time and on budget; prevent, stop and cure diseases; ensure everyone has access to healthcare today and for generations to come; drive cross-site equivalency and unparalleled efficiencies; accountable for its success across the network; establishing the specific standards for DP manufacturing systems to be deployed across the global network; ensuring they meet the defined global standards for the production network; maintaining the equivalency of DP fleet equipment & systems throughout their entire lifecycle; ensuring consistent implementation across all affected DP sites; advance science; deliver life-changing healthcare solutions that make a global impact
Industry & Context.
analysis of proposed changes; side-by-side comparative analyses; assessment of unplanned events or discrepancies
What They're Looking For.
Must Have
Master’s degree in Engineering (Chemical, Mechanical, Bioengineering), Life Sciences, or a related technical PhD is strongly preferred., A minimum of 15 years of experience in the pharmaceuticaliotech industry, with a emphasis on Drug Product manufacturing and multi-site operations at a global scale., 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., track record of leading change management processes in a highly regulated environment with a focus on cross-site impact
Nice to Have
PhD is strongly preferred.
What You'll Do.
and drive global strategy and roadmap for Drug Product Fleet concept
Serve as primary point of accountability for DP-specific fleet systems
Ensure equivalency of DP fleet equipment & systems lifecycle
Present global operating budget (CAPEX and OPEX) and resource allocation
Lead and act as primary point of contact for health authority interactions
Ensure DP fleet equipment adheres strictly to global documents
Own and maintain DP-specific lifecycle deliverables
Lead analysis of proposed changes on DP fleet equivalency
Conduct and oversee side-by-side comparative analyses
Oversee continuous monitoring of DP fleet performance
Ensure unplanned events or discrepancies impacting DP equipment are assessed
How You'll Work.
Team & Collaboration
drive alignment and decision-making across diverse functional groups and geographical locations; collaboration with key stakeholders
Process & Methodology
leading global Capex projects from planning through execution, providing project management, project performance on time and on budget
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