Vice President, Ireland Manufacturing Operations
Vice President, Ireland Manufacturing Operations
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Job Description
At Gilead were creating a healthier world for all people. For more than 35 years weve tackled diseases such as HIV viral hepatitis COVID-19 and cancer working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.
Every member of Gileads team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions and were looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future you are the key driver in evolving our culture and creating an environment where every employee feels included developed and empowered to fulfil their aspirations. Join Gilead and help create possible together.
Job Description
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 Gileads 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 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 products 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.
Gilead Core Values
Integrity (Doing Whats Right)
Inclusion (Encouraging Diversity)
Teamwork (Working Together)
Excellence (Being Your Best)
Accountability (Taking Personal Responsibility)
Equal Employment Opportunity (EEO)
It is the policy of Gilead Sciences Inc. and its subsidiaries and affiliates (collectively Gilead or the Company) to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law all employment actions relating to issues such as compensation benefits transfers layoffs returns from layoffs company-sponsored training education assistance social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds which may include an individuals gender race color national origin ancestry religion creed physical or mental disability marital status sexual orientation medical condition veteran status and age unless such protection is prohibited by federal state municipal provincial local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.
For Current Gilead Employees and Contractors:
Please apply via the Internal Career Opportunities portal in Workday.
Required Experience:
Chief
Employment Type
Full-Time
