Sr Manager, Outsourced Manufacturing

Gilead Sciences•Foster City, CA

7d•$157,590 - $203,940•Onsite

About The Position

The Senior Manager, Global External Manufacturing (GEM) Oral-Solid Dosage (OSD) supports uninterrupted supply of Gilead clinical and commercial products manufactured through its global external contract manufacturing network. The role oversees and contributes to technical and operational activities while ensuring compliance with cGMP, regulatory requirements, and environmental, health, and safety legislation. It is part of the Manufacturing Operations group within Pharmaceutical Development and Manufacturing (PDM) and is based at Gilead's Foster City campus. The position collaborates with Technical Development, Quality, Regulatory, Analytical, Supply Chain, and Product & Portfolio Strategy teams to support technology transfer and validation, commercialization, launch, routine supply, and proactive management of changes throughout product lifecycles. It also manages contract manufacturing organizations (CMOs), resolves technical and compliance issues, supports continuous improvement and sustainability of supply, and contributes to regulatory filings and product strategy.

Requirements

At least 8 years of progressively responsible experience in a pharmaceutical or biotechnology organization and a BA or BS degree in science or engineering. An MS or MBA may substitute for 2 years of relevant experience, or a Ph.D. may substitute for 4 years.
Strong computer, organizational, and project management skills.
Experience or working understanding of manufacturing principles governed by current Good Manufacturing Practices (cGMP), and working knowledge of worldwide regulatory requirements, including pharmaceutical ICH guidance.
Experience in pharmaceutical drug product manufacturing or technical operations and supply chain execution and oversight.
Experience in manufacturing and quality risk management at external manufacturing sites.
Ability to travel internationally, including overnight travel, up to 20% of the time.
Exceptional verbal, written, and interpersonal communication skills, including the ability to interact effectively with senior management at Gilead and contract manufacturing organizations.
Ability to understand and contribute to resolving complex situations.
Experience supporting regulatory inspections and audits in partnership with QA.
Advanced expertise in vendor qualification, contract negotiation, and supplier performance management.

Nice To Haves

An advanced degree in science, engineering, or business is desirable.
Understanding of the contract manufacturing organization landscape and knowledge of worldwide drug product manufacturing capabilities and limitations.
Experience in OSD drug product manufacturing and supply chain execution and oversight in the pharmaceutical industry.

Responsibilities

Execute Gilead’s supply network strategy within GEM and contribute to defining technical requirements for selecting CMOs.
Lead or represent GEM on CMO Management Teams, influence CMO performance, execute business plans, and monitor Key Performance Indicators.
Collaborate across PDM and external organizations to achieve departmental, cross-functional, and corporate goals.
Execute inter- and intra-company technical transfers, partnering with Technical Development and internal manufacturing sites to support technology transfer and validation.
Manage CMOs tactically to ensure products are manufactured according to registered processes and approved Master Production Records.
Enable timely resolution of complex manufacturing, product quality, and compliance issues, including trending, continued process verification, investigations, change management, deviations, and product complaints.
Provide on-site technical support at CDMO sites as needed.
Identify and facilitate continuous improvement initiatives to reduce costs, improve quality, increase efficiency, and ensure sustainability of supply.
Represent GEM on cross-functional PDM development or commercial teams as needed, managing product strategy throughout the product lifecycle.
Write or review qualification, validation, technical, and deviation reports; prepare regulatory filing documents and review filings, including sections from other disciplines.