Job Title:
Operations Director, Ireland Manufacturing
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Job Description:
The Operations Director will oversee the commercialization, manufacturing, testing and release of products for international markets. This role provides leadership to a team responsible for manufacturing, packaging, analytical test and release, engineering, supply chain, drug product scaleup and commercialization of commercial products at a Cork manufacturing site and clinical manufacturing of drug candidates.
This position is accountable for advancing the commercial product portfolio for international markets. The Operations Director is the primary legal representative as a director and chairman of a company and is responsible for providing cross-functional leadership as the Site Lead for the Cork Manufacturing Plant.
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.
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Key Responsibilities:
* Provide leadership and direction to the operations organization;
* Lead the cross-functional 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 company values, 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;
* Advance the commercial product portfolio by providing overall CMC oversight, direction, and decision-making;
* Support regulatory filings by guiding the draft, review, and approval of CMC sections;
* Provide technical support to internal and external cGMP manufacturing operations;
* Interface between the company and other pharmaceutical companies, business and scientific organizations, main customers, suppliers, and external media.
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Qualifications and Experience:
A Bachelor's degree in Business or Science and minimum 14 years of relevant experience in related field. Alternatively, 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.
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.
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Gilead Core Values:
* Integrity (Doing What's Right)
* Inclusion (Encouraging Diversity)
* Teamwork (Working Together)
* Excellence (Being Your Best)
* Accountability (Taking Personal Responsibility)
* Equal Employment Opportunity (EEO)