Assoc Director, Validation

Job Description

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

Key Responsibilities :

• Lead strategy and execution of complex sterile product qualification activities.
• Expertise in contamination control, cleaning validation and isolator systems.
• Adopt best practices for continuous qualification of sterile production facilities.
• Provides relevant CMC support for sterile products pre- and post-approval filings.
• Interface with Senior Leadership Team to provide a unified set of goals and objectives for the Validation team.
• Assist with onboarding of new technologies and provide oversight for new qualification programs.
• Work with Quality to adopt an effective quality management system and achieve the quality objectives.
• Provide leadership for Validation team and ensure growth and development of staff to meet changing business needs.
• Forecast external support requirements for continuous validation support, including implementation of new projects.
• Ensure continuing suitability and effectiveness of the quality management system and GMP compliance through participation in management review.
• Oversee the development and implementation of validation strategy for Gilead portfolio of products and / or across engineering and validation sub-functions.
• Collaborates cross-functionally and geographically with stakeholders to ensure that product distribution and validation processes are aligned to the needs of Gilead and its customers, ensuring that best practice, compliance and alignment with business needs.
• Works directly with international affiliates and distributors to ensure that regulatory inspections are managed in accordance with Gilead corporate guidelines and responses are submitted in accordance with regulatory requirements.
• Conducts and serves as a lead / coordinator of investigations and corrective and preventative action (CAPA) recommendations related to distribution 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.

Basic Qualifications :

Preferred Qualifications :

The salary range for this position is : $165,495.00 - $214,170.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. 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