Overview
Vice President, Ireland Manufacturing Operations based at the Cork facility in Carrigtwohill, Co. Cork. The VP will oversee stage commercialization, manufacturing, test and release of Gilead products for international markets. The role provides leadership to Manufacturing, Packaging, Analytical Test and Release, Engineering, Supply Chain, Drug Product Scale-up and Commercialization of commercial products at the Cork site and clinical manufacturing of drug candidates at the Cork facility. The VP is the primary legal representative as a director and chairman of GSIUC and is responsible for cross‑functional leadership as the Site Lead for the Cork Manufacturing Plant. This position is site based and requires some international travel, including to the United States. The VP will be a member of the PDM Manufacturing Leadership Team.
Responsibilities
* Provide leadership and direction to the Ireland Manufacturing Operations organization; Lead the cross-functional Ireland Manufacturing Operations Leadership team in the development of medium and long-term strategic plans and lead the management team in the execution of operational plans.
* Hire, mentor, and develop team members within the organization. Set performance goals and hold employees accountable for their performance. Lead the performance and talent management processes for the site.
* Build and maintain a site culture consistent with the Gilead values, with emphasis on quality and safety.
* Develop and manage department budget and ensure company accounts comply with statutory accounting practices.
* Accountable for fulfilling legal and fiscal responsibilities as a company director for GSIUC enshrined in company law.
* Advance commercial product portfolio by providing overall CMC oversight, direction and decision making.
* Provide strategic directions to all commercial products through interactions with each product’s PDM (CMC) team.
* Serve as a senior member of the PDM Manufacturing Leadership Team responsible for developing and establishing clinical & commercial manufacturing strategy and site operations.
* Oversee late-stage commercialization, scale up and technical transfer of development drug products to commercial manufacturing. Support drug product registration and commercial launches.
* Evaluate and implement new technologies and approaches to drive innovation in drug product development, testing, and manufacturing.
* Drive development and implementation of new systems to improve project execution and data management.
* Lead collaborations with Gilead Pharmaceutical Development and Manufacturing functions such as Quality, Technical Development, CMC Regulatory, Product Strategy, SPDM Strategy and Operations, and Global Supply Chain.
* Support regulatory filings by guiding the draft, review, and approval of CMC sections; support associated agency interactions and product-related inspections.
* Provide technical support to internal and external cGMP manufacturing operations.
* Interact with governmental bodies as company representative for legal/statutory issues.
* Interface between the company and other pharmaceutical companies, business and scientific organisations, main customers, suppliers and external media.
* Responsible for compliance with all health, safety, environmental and employment laws.
Qualifications
* BA or BSc degree in Business or Science with minimum 14 years of relevant experience; alternatively, MSc/MA or MBA with minimum 12 years of relevant experience.
* Experience leading commercial drug product manufacturing operations across multiple functions (solid oral dose manufacturing and packaging, supply chain, logistics and distribution, Formulation/Drug Product Process Development, and Analytical Operations including Quality Control).
* Experience supporting multiple regulatory filings and inspections by regulatory agencies, with emphasis on US, EU, and Japanese agencies.
* Experience developing, implementing and executing strategic plans and objectives for organizations and departments.
* Experience working with external manufacturing and testing organizations.
* In-depth understanding of ICH guidelines and GMP requirements for development and manufacturing of biologics; solid understanding of current industry trends and regulatory expectations.
* Strong leadership and communication skills; ability to collaborate, develop high-performing teams, and drive accountability and cross-functional engagement.
Gilead Core Values
* Integrity (Doing What’s Right)
* Inclusion (Encouraging Diversity)
* Teamwork (Working Together)
* Excellence (Being Your Best)
* Accountability (Taking Personal Responsibility)
EEO
Equal Employment Opportunity (EEO): It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates to recruit and employ the most qualified persons available for positions throughout the Company, on a non-discriminatory basis. All employment actions are administered without regard to protected characteristics or prohibited grounds under applicable laws.
For Current Gilead Employees And Contractors: Please apply via the Internal Career Opportunities portal in Workday.
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