Senior Manager of International Product Operations

This is a leadership role that oversees the commercialization, manufacturing, test and release of products for international markets.

The successful candidate will provide strategic direction to all commercial products through interactions with each product's team.

They will oversee late-stage commercialization, scale up and technical transfer of development drug products to commercial manufacturing. Support drug product registration and commercial launches.

The ideal candidate has experience leading commercial drug product manufacturing operations across multiple functions including solid oral dose manufacturing and packaging, supply chain, logistics and distribution, Formulation/Drug Product Process Development, and Analytical Operations including Quality Control.

In addition they have experience supporting multiple regulatory filings and inspections by regulatory agencies with emphasis on US, EU, and Japanese agencies.

• Provide leadership and direction to the organization; Lead the cross-functional 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 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 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 Manufacturing Leadership Team responsible for developing and establishing clinical & commercial manufacturing strategy and site operations.
• 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 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 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.

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: It is the policy of 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.

Please apply via the Internal Career Opportunities portal in Workday.