Exec Director Quality

Gilead Sciences is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams. For Current Gilead Employees and Contractors: Please log onto your Internal Career Site to apply for this job. Job Description Gilead Sciences Executive Director, QA San Dimas and La Verne, CA Sites Knowledge: Demonstrates in-depth understanding and application of GMP principles, concepts, best practices and standards in the US and internationally. Is able to develop and improve complex concepts, techniques, and standards and new applications based on quality principles and theories. Demonstrates strong knowledge of aseptic processing, solid dose and general pharmaceutical manufacturing. Is able to develop solutions to complex problems, which require a high degree of ingenuity, creativity and innovativeness, and where precedent may not exist. Demonstrates extensive knowledge of industry best practices and trends. Demonstrates excellent verbal, written, and interpersonal communication skills. Is comfortable interacting with regulatory agencies as needed, and possesses the ability to represent Gilead in public forums. Demonstrates experience and ability to manage staff. Is an experienced auditor with demonstrated acumen in resolving challenging audit situations. Specific Education & Experience Requirements: 12 - 15 years of relevant experience and a Bachelor''s degree in science or related fields. 8+ years of relevant experience and an advanced science degree such as MS, MD, PharmD, PhD or an advanced business degree such as an MBA. Prior people management experience. Deep knowledge and experience in quality assurance in a highly regulated manufacturing environment. Biopharmaceutical or Pharmaceutical experience preferred. Broad experience across areas like CMO QA, Validation, Drug development experience and/or Pharmacovigilance and understanding of Parenteral, Aseptic and API operations is beneficial. Specific Job Responsibilities: Oversees the development and implementation of Quality strategy for Gilead portfolio of products and/or across quality sub-functions. Provides leadership and operational excellence to enable the Quality function to work effectively in a commercial environment, including the appropriate allocation of resources. Collaborates cross-functionally and geographically with stakeholders to ensure that product distribution processes are aligned to the needs of Gilead and its customers, ensuring best practice, compliance and alignment with business needs. Monitors and ensures compliance with new GMP and GDP regulations. Establishes and publishes Key Performance Indicators to track GMP and GDP compliance across operations. Ensures that Quality systems and practices are developed and implemented across all international affiliates and distributors engaged in any aspect of distribution. Works directly with international affiliates and distributors to ensure that regulatory inspections are managed in accordance with Gilead corporate guidelines and regulatory requirements. Leads standardization and harmonization of Standard Operating Procedures, leveraging existing Gilead Quality systems. Interfaces with regulatory agencies as required, representing Gilead to authorities and regulatory inspectorates. Leads preparations for and participates in regulatory authority inspections. Performs the QA review of externally and internally generated reports/documents as necessary. Develops an effective working relationship with all team members and external contractors. Leads/coordinates investigations, and the development and implementation of corrective and preventative action (CAPA) recommendations related to distribution activities. For jobs in the United States: As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans'' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact [Click Here to Email Your Resumé] for assistance. Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S., Canada, Australia, and Singapore employees and contractors to receive the COVID-19 vaccines as a condition of employment. "Full vaccination" is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation."‹ For more information about equal employment opportunity protections, please view the ''EEO is the Law'' poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT PAY TRANSPARENCY NONDISCRIMINATION PROVISION Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team. Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion. For Current Gilead Employees and Contractors: Please log onto your Internal Career Site to apply for this job. 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Created: 2025-11-15