As a senior executive, you will oversee the commercialization and manufacturing of Gilead products for international markets. This role is responsible for providing leadership to an organization responsible for Manufacturing, Packaging, Analytical Test and Release, Engineering, Supply Chain, Drug product Scaleup and Commercialization of commercial products at the Cork Manufacturing site and clinical manufacturing of drug candidates at the Cork facility.
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The ideal candidate will have a strong background in managing commercial drug product manufacturing operations, including solid oral dose manufacturing and packaging, supply chain, logistics, and distribution. Experience with regulatory filings and product-related inspections is also essential. Additionally, the successful candidate will have a proven track record of developing and executing strategic plans and objectives for organizations and departments.
This is a site-based role located at the facility in Carrigtwohill, Co. Cork. Some international business travel, including to the United States will be required. The VP will be a member of the PDM Manufacturing Leadership Team.
Responsibilities include:
* Providing leadership and direction to the Ireland Manufacturing Operations organization;
* Leading the cross-functional Ireland Manufacturing Operations Leadership team in the development of medium and long-term strategic plans and leads the management team in the execution of operational plans;
* Hiring, mentoring, and developing team members within the organization;
* Setting performance goals and holding employees accountable for their performance;
* Leading the performance and talent management processes for the site;
* Accountable for fulfilling legal and fiscal responsibilities as a company director for GSIUC enshrined in company law;
* Advancing commercial product portfolio by providing overall CMC oversight, direction, and decision-making;
* Providing strategic directions to all commercial products through interactions with each product's PDM (CMC) team;
* Serving as a senior member of the PDM Manufacturing Leadership Team responsible for developing and establishing clinical & commercial manufacturing strategy and site operations;
* Overseeing late-stage commercialization, scale-up, and technical transfer of development drug products to commercial manufacturing;
* Supporting drug product registration and commercial launches;
* Evaluating and implementing new technologies and approaches to drive innovation in drug product development, testing, and manufacturing;
* Driving development and implementation of new systems to improve project execution and data management;
* Leading 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;
* Supporting regulatory filings by guiding the draft, review, and approval of CMC sections; supporting associated agency interactions and product-related inspections;
* Providing technical support to internal and external cGMP manufacturing operations;
* Interacting 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.