Gilead.com
Director, Global External Manufacturing, OSD
Gilead.com, California City, California, us, 93504
Overview
Director, Global External Manufacturing, OSD – leads a team to ensure uninterrupted supply of Gilead’s clinical and commercial products through execution of manufacturing campaigns within the global external contract manufacturing network, while ensuring compliance with cGMP, regulatory requirements, and environmental, health, and safety legislation. This role is part of the Manufacturing Operations group within the Pharmaceutical Development and Manufacturing organization (PDM). The preferred candidate will have experience managing, training, and mentoring staff. Key Responsibilities
Lead Global External Manufacturing to execute the network strategy; responsible for tactical manufacturing strategy, execution of the business with external manufacturing organizations, and management of supplier performance. Partner in development of department strategy aligned with corporate and PDM goals into functional/departmental objectives to realize targeted outcomes. Proactively collaborates with functions within and external to PDM to achieve corporate, cross-functional, and departmental goals. In collaboration with the Technical Development Organization, defines technical requirements and partners with Global Supply Chain in selecting CMOs; influence overall performance of the network CMOs to achieve strategic and tactical outcomes, including KPIs. Partner with Technical Development and internal Gilead manufacturing sites for technology transfer and validation of new or existing processes/products to identified CMO(s). Lead regular, tactical management of CMOs to ensure products are manufactured per registered process and approved Master Production Record. Facilitate timely resolution of complex manufacturing and compliance issues, including deviations, investigations, change control, and product trending. Foster continuous improvement of production and business processes to reduce cost, improve quality, increase efficiency, and ensure sustainability. May represent Gilead as a liaison with governmental agencies as required. Qualifications
Demonstrated track record in oral solid dosage drug product manufacturing and supply chain execution in the pharmaceutical industry. Expertise in supply risk management with knowledge of industry and system best practices. Experience with cGMP and regulatory requirements, including ICH guidance. Understanding of the contract manufacturing organization (CMO) landscape; knowledge of CMO capabilities for worldwide manufacturing is a plus. Ability to travel internationally, up to 10% of the time. Exceptional verbal and written communication, including interaction with senior management. Proven leadership to contribute to the success of PDM and Gilead. 12+ years of progressively responsible experience in a pharmaceutical/biotech organization and a BA/BS in science or engineering; advanced degree desirable. MBA can substitute 2 years, PhD can substitute 4 years. Gilead Core Values
Integrity (Doing What’s Right) Inclusion (Encouraging Diversity) Teamwork (Working Together) Excellence (Being Your Best) Accountability (Taking Personal Responsibility) Compensation and Benefits
The salary range for this position is $210,375.00 – $272,250.00. Compensation may vary based on experience and location. This position may be eligible for discretionary annual bonus, stock-based long-term incentives, paid time off, and a benefits package, including medical, dental, vision, and life insurance plans. Additional Information
For benefits information, visit the Gilead careers site. For current Gilead employees and contractors, apply via the Internal Career Opportunities portal in Workday. Gilead is an equal employment opportunity employer and maintains an inclusive work environment.
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Director, Global External Manufacturing, OSD – leads a team to ensure uninterrupted supply of Gilead’s clinical and commercial products through execution of manufacturing campaigns within the global external contract manufacturing network, while ensuring compliance with cGMP, regulatory requirements, and environmental, health, and safety legislation. This role is part of the Manufacturing Operations group within the Pharmaceutical Development and Manufacturing organization (PDM). The preferred candidate will have experience managing, training, and mentoring staff. Key Responsibilities
Lead Global External Manufacturing to execute the network strategy; responsible for tactical manufacturing strategy, execution of the business with external manufacturing organizations, and management of supplier performance. Partner in development of department strategy aligned with corporate and PDM goals into functional/departmental objectives to realize targeted outcomes. Proactively collaborates with functions within and external to PDM to achieve corporate, cross-functional, and departmental goals. In collaboration with the Technical Development Organization, defines technical requirements and partners with Global Supply Chain in selecting CMOs; influence overall performance of the network CMOs to achieve strategic and tactical outcomes, including KPIs. Partner with Technical Development and internal Gilead manufacturing sites for technology transfer and validation of new or existing processes/products to identified CMO(s). Lead regular, tactical management of CMOs to ensure products are manufactured per registered process and approved Master Production Record. Facilitate timely resolution of complex manufacturing and compliance issues, including deviations, investigations, change control, and product trending. Foster continuous improvement of production and business processes to reduce cost, improve quality, increase efficiency, and ensure sustainability. May represent Gilead as a liaison with governmental agencies as required. Qualifications
Demonstrated track record in oral solid dosage drug product manufacturing and supply chain execution in the pharmaceutical industry. Expertise in supply risk management with knowledge of industry and system best practices. Experience with cGMP and regulatory requirements, including ICH guidance. Understanding of the contract manufacturing organization (CMO) landscape; knowledge of CMO capabilities for worldwide manufacturing is a plus. Ability to travel internationally, up to 10% of the time. Exceptional verbal and written communication, including interaction with senior management. Proven leadership to contribute to the success of PDM and Gilead. 12+ years of progressively responsible experience in a pharmaceutical/biotech organization and a BA/BS in science or engineering; advanced degree desirable. MBA can substitute 2 years, PhD can substitute 4 years. Gilead Core Values
Integrity (Doing What’s Right) Inclusion (Encouraging Diversity) Teamwork (Working Together) Excellence (Being Your Best) Accountability (Taking Personal Responsibility) Compensation and Benefits
The salary range for this position is $210,375.00 – $272,250.00. Compensation may vary based on experience and location. This position may be eligible for discretionary annual bonus, stock-based long-term incentives, paid time off, and a benefits package, including medical, dental, vision, and life insurance plans. Additional Information
For benefits information, visit the Gilead careers site. For current Gilead employees and contractors, apply via the Internal Career Opportunities portal in Workday. Gilead is an equal employment opportunity employer and maintains an inclusive work environment.
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