Sr. Director, Validation

Gilead Sciences • La Verne, CA

6d

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: Must have in-depth understanding and application of GMP principles, concepts, practices and standards in the US and internationally. Able to develop and improve complex concepts, techniques, and standards and new applications based on quality principles and theories. Able to develop solutions to complex problems, which require a high degree of ingenuity, creativity and innovativeness. Able to exercise judgment and independently determine and take appropriate action where precedent may not exist. Demonstrates extensive knowledge of industry best practices and trends. Excellent verbal, written, and interpersonal communication skills are required. Requires experience and ability to manage staff.

Requirements

• 12-15 years of relevant experience and bachelor’s degree in science or related field.
• Prior people management experience.
• Must have in-depth understanding and application of GMP principles, concepts, practices and standards in the US and internationally.
• Able to develop and improve complex concepts, techniques, and standards and new applications based on quality principles and theories.
• Able to develop solutions to complex problems, which require a high degree of ingenuity, creativity and innovativeness.
• Able to exercise judgment and independently determine and take appropriate action where precedent may not exist.
• Demonstrates extensive knowledge of industry best practices and trends.
• Excellent verbal, written, and interpersonal communication skills are required.
• Requires experience and ability to manage staff.

Nice To Haves

• An advanced science degree such as MS, MD, PharmD, PhD or an advanced business degree such as an MBA is desirable.
• Deep knowledge and experience in validation in highly regulated manufacturing environments is preferred.
• Biopharmaceutical or Pharmaceutical experience preferred.

Responsibilities

• Oversees the development and implementation of validation strategy for Gilead portfolio of products and/or across validation sub-functions.
• Establishes and publishes Key Performance Indicators to track GMP, GDP compliance across operations.
• Works with senior and executive management, develops plans and strategic direction for the validation function
• Collaborates cross-functionally with stakeholders to ensure that product validation processes are aligned to the needs of Gilead and its customers, ensuring that best practice, compliance and alignment with business needs.
• Serves as a lead/coordinator of investigations and corrective and preventative action (CAPA) recommendations.
• 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.

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