Exec Director, MSAT

Role Summary

Exec Director, MSAT at Gilead. Lead and oversee tech transfer, validation, and MSAT functions to support rapid, compliant product introductions and ongoing manufacturing excellence. Drive strategic direction, staff development, and cross-functional collaboration to ensure GMP/GDP compliance and effective technology transfer across sites.

Responsibilities

• Provide leadership related to best Practices pertaining to tech transfer and validation
• Interface with Senior Leadership Team to provide a unified set of goals and objectives for the dept.
• Assist with onboarding of new technologies and provide oversight for new qualification programs.
• Ensure growth and development of staff to meet changing business needs.
• Conducts and serves as a lead/coordinator of investigations and corrective and preventative action (CAPA) recommendations related to tech services and validation activities.
• Interfaces with Regulatory agencies as required representing Gilead to authorities and regulatory inspectorates in matters relating to GMP.
• Leads standardization and harmonization of Standard Operating Procedures, leveraging existing Gilead Quality Systems.
• Ensure coordination and synchronization between the two groups (tech transfer and validation) for the benefit of new product introduction or projects
• Lead strategic and tactical operations of a team across the Technical Services Department. Ultimate responsibility for staff development, budgeting and cost control, and strategic planning of a Technical Services department.
• Provide direction and assistance on resolution of complex issues related to multiple drug forms.
• Develop action plans for future implementation of systems to meet long-term objectives; act as escalation point for complex/high impact technical services issues/decisions.
• May lead cross-functional PDM teams for a program with responsibility for planning and execution of program strategy through all stages of development.
• For commercial manufacturing, lead commercial projects with responsibility for process performance, CPV, optimization, and investigations.
• Direct the planning and execution of process development considering efficiency, scalability, safety, regulatory factors, and cost of goods.
• May advise senior management on process development and R&D direction.
• Determine organizational objectives and interpret company policies to meet goals; review and approve capital expenditure.
• Ensure all departments operate in accordance with SOPs meeting regulatory and GMP standards.
• Liaise with Pharmaceutical Manufacturing and Development teams on technical transfer of new products across sites; may serve as liaison to governmental agencies.
• Assist in investigations including deviations, complaints, OOS investigations, Material Review Boards, trend analysis, and change control.
• Oversee the development and implementation of commissioning and validation strategy for Gilead portfolio of products and/or across engineering and validation sub-functions.
• Manage strategic and tactical operations of the validation department; establish KPIs for GMP/GDP compliance; align validation processes with stakeholder needs.

Qualifications

• 16+ years of experience in the pharmaceutical industry and a BS or BA OR 14+ years of relevant experience and an advanced science degree (MS, MD, PharmD, PhD) or MBA.
• Prior people management and leadership experience.
• Deep knowledge and experience in validation and tech transfer in highly regulated manufacturing environments.
• Experience with Biologics Products and Sterile manufacturing.
• Biopharmaceutical or Pharmaceutical experience required.
• Must be willing to be based out of the La Verne, CA site.

Skills

• Extensive knowledge of industry best practices and trends; ability to develop and improve complex concepts and solutions to problems requiring ingenuity and innovativeness.
• Strong judgment, verbal and written communication, and interpersonal skills.
• Proven experience in managing staff and cross-functional collaboration.
• Deep knowledge of GMP principles, concepts, practices, and standards in the US and internationally.

Education

• BS/BA required; advanced degree (MS/PhD/MD/PharmD) or MBA preferred.

Additional Requirements

• Based in La Verne, CA or willing to relocate.