Director, Validation

Gilead Sciences • La Verne, CA

8d

About The Position

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve 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 world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead’s 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 we’re 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 Knowledge: Broad knowledge of GMP principles, concepts, practices and standards in the US and internationally. Able to develop and improve concepts, techniques, and standards. Develops new applications based on quality principles and theories. Able to provide solutions to highly complex problems, which require a high degree of ingenuity, creativity and innovativeness. Able to manage challenges, which are unique and provide solutions that may serve as precedent for future decisions. Interprets, executes, and recommends modifications to company-wide policies to achieve corporate goals and objectives. Comfortable interacting with regulatory agencies as needed and possess the ability to represent Gilead in public forums. Develops budgets and monitors expenditures.

Requirements

• 12+ years of relevant experience and bachelor’s degree in science or related field.
• 10+ years of relevant experience and a MS or MBA.
• Broad knowledge of GMP principles, concepts, practices and standards in the US and internationally.
• Able to develop and improve concepts, techniques, and standards.
• Develops new applications based on quality principles and theories.
• Able to provide solutions to highly complex problems, which require a high degree of ingenuity, creativity and innovativeness.
• Able to manage challenges, which are unique and provide solutions that may serve as precedent for future decisions.
• Interprets, executes, and recommends modifications to company-wide policies to achieve corporate goals and objectives.
• Comfortable interacting with regulatory agencies as needed and possess the ability to represent Gilead in public forums.
• Develops budgets and monitors expenditures.

Responsibilities

• Manages validation department, including organizing and prioritizing departmental goals and objectives, performing training, and writing performance reviews for direct reports.
• Oversees the completion of projects through the development and approval of validation schedules, project plans, master plans, validation protocols and reports for systems that may be complex in nature to support clinical and commercial manufacturing.
• Manages validation activities with Development, Manufacturing, Engineering, Quality, and other groups on projects.
• Manages the activities of assigned validation and contract personnel to ensure the quality of completed work.
• Provides technical assessment and validation approval for engineering and process changes.
• Reviews and approves protocols, reports and data tables generated by subordinates and contract personnel.
• As required, prepares regulatory submissions and presents validations to regulatory authorities during routine internal and pre-approval inspections.
• Ensures solutions are consistent with organizational objectives.
• Leads compliance audits as required.
• Interfaces with contract manufacturers to address documentation and compliance issues.
• Writes and/or implements changes to controlled documents (e.g., SOPs, Specifications, Methods, etc.) as needed.

Benefits

• This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package.
• Benefits include company-sponsored medical, dental, vision, and life insurance plans.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees