Vice President, Ireland Manufacturing Operations

职位描述

The Vice President, Ireland Manufacturing Operations will be responsible for overseeing stage commercialization, manufacturing, test and release of Gilead products for international markets. The VP will provide 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. The VP is the primary legal representative as a director and chairman of Gilead Sciences Ireland UC and is responsible for providing cross functional leadership as the Site Lead for the Cork Manufacturing Plant.

As the leader of Ireland Manufacturing Operations, this position is accountable for advancing Gilead’s commercial product portfolio for international markets. This role is site based and located at the facility in Carrigtwohill, Co. Cork. Some international business travel, including to the United States will be required. In addition, 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 leads 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, and with an added 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 and minimum 14 years of relevant experience in related field. Alternately, an MSc/MA or MBA degree and minimum 12 years of relevant experience.

• Experience leading commercial drug product manufacturing operations consisting of representatives from multiple functions such as 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 supporting product-related inspections for regulatory agencies, with special emphasis on the US, EU, 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.

• Exceptional interaction, leadership and command skills are required.

• Leadership qualities of the successful candidate include the following: collaboration, building and developing high performing teams, accountability, cross functional engagement and influence, program management, strategic vision, executive presence.