Principal Site Manager Contract Manufacturing - #19529199


Date: Feb 23, 2021
City: South San Francisco, CA
Contract type: Full time

The Drug Product External Manufacturing organization runs the manufacturing and packaging of sterile and solids drug product across contract manufacturing organizations (CMOs), primarily in Europe and North America. As a Site Manager, you will be responsible for the manufacturing lifecycle processes related to products and/or semi-finished products manufactured by Contract Manufacturing Organizations (CMO). You will be leading cross-functional projects and a JMT (joint management team) responsible for GMP, quality and compliance standards for manufacturing principles for the relevant CMOs and accountable for monitoring quality, compliance and regulatory aspects. Key responsibilities are:

Selection Phase

  • Participates in and contributes to CMO selections and evaluates a CMO's capacity and capability as an input to a sourcing decision. Influences and supports the decision making process.

  • Contributes to developing and negotiating contracts in general and financial agreements in particular.

Implement-Manage Phase

  • Leads product launches and technology transfers to and/or from a CMO. Develops an in-depth knowledge of the CMO manufacturing process and systems.

  • Ensures the execution of production at the CMO and the Order & Supply Manager to deliver an uninterrupted and timely supply of commercial product meeting all Quality Requirements.

  • Identifies supply constraints and leads timely resolution of issues.

  • Monitors production campaigns and reports on CMO's performance against plans, including negotiation of quality and supply improvement plans for adverse trend performance.

  • Identifies, notifies and/or escalates risks and issues that may affect project timelines, resource requirements, finances, or business relationship.

  • Facilitates the identification, prioritization, planning and execution of technical projects and ensures a successful and timely completion of deliverables

  • Owns planning and execution of technical changes within Roche that have regulatory and/or multi-site impact.

  • Ensures that corporate safety, health and environment (SHE) and quality audits are performed and mitigations plans are in place for the CMO to comply with terms of agreements, corporate group policy and local legal requirements.

  • Closely collaborates with the Order & Supply Manager for supply-related matters, the Quality Site Manager for quality-related topics, the CMO Artwork Manager for artwork-related matters and global MSAT for technical topics.

  • Contributes to or leads price and contract negotiation on product and projects.

  • Owns budget related to specific CMO for MAR, projects and tech transfers

  • Ensure the appropriate alignment with other cross-functional teams and stakeholders (e.g. product strategic teams) on execution of product strategic topics

Decommissioning Phase

  • Leads decommissioning of a CMO following either termination or expiration of an agreement.

Continuous Improvement

  • Participates in operational excellence & business process project teams to build and utilize robust business processes for CMO management.

Requirements & Qualifications

  • 8+ years' experience successfully working in an operations environment, with at least 5 years of managing large, complex cross-functional projects. BS in the relevant Engineering or Life Sciences field discipline is required. An advanced degree (MBA, MS, or PhD) is desired.

  • Experience working with Contract Manufacturers is desired with overall knowledge of solids or steriles DP commercial manufacturing in a GMP-regulated environment. Previous experience in technology, quality or supply chain roles is desired.

  • Strong cross-functional leadership skills and the ability to collaborate and communicate at different hierarchy levels

  • Certification in Project Management (e.g. PMI) or additional relevant management training is a plus.

  • Certified/expertise in improvement or problem solving methodologies (Six Sigma, Lean, RCA) is a plus.

  • The position may require up to 25% domestic and international travel.

  • LI-KD1

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