Executive Director, Quality Assurance Biologics
Executive Director, Quality Assurance Biologics
United States - California - Foster City
Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
Making an impact on a global scale
Inclusion is one of the companys five core values. Thats because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.
When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible
Executive Director, Quality Assurance Biologics - Foster City, CA
- Responsible for an effective quality management system in place to achieve the quality objectives of global biologics operations.
- Responsible for strategy creation, direction, and execution of global quality biologics.
- Directs appropriate resources to effectively maintain the quality management system and leads continuous improvement efforts.
- Responsible for progressing the suitability and effectiveness of the global biologics quality management system and GMP compliance through participation in organizational quality management reviews.
- Leads biologics operations leadership team (Oceanside, CA, Foster City, CA, Morris Plains, NJ) in developing business/operational plans across multiple functions and accountable for implementation.
- Member of senior management team focusing on strategic issues across multiple functions and sites.
- Lead in the preparation and quality/compliance review of BLA/IND/IMPD regulatory submissions for US and worldwide health agencies.
- Collaborate with Process Development and Technical Manufacturing Ops teams for new biologic product introductions and provide quality leadership throughout all phases of product development.
- Primary lead with regulatory agencies as required, representing Gilead during health authority inspections
- Provides leadership direction for a multi-functional group of quality professionals, aligned with company culture that recognizes market practices and regulatory trends to achieve a uniform Quality strategy.
- Coaches, leads and mentors direct reports and builds a highly capable team through the attraction, training and development of the necessary skilled professionals to meet business needs.
- Member of leadership team networking with Gilead's senior management on matters concerning several functional areas and/or customers impacting biologic operations.
Knowledge & Skills
- Knowledgeable of the principles of GxPs, specifically to biologics.
- Demonstrates ability to quickly establish credibility with diverse audiences and be perceived as a leader.
- Demonstrates excellent verbal, written, and interpersonal communication skills, as well as excellent influencing skills.
- Demonstrates significant in-depth understanding of business objectives and how they translate into quality priorities.
- Has the experience and confidence necessary to work with senior executives, and the ability to build rapport with employees at all levels.
- Demonstrates experience and ability to manage staff.
- Able to develop solutions to complex problems, which require a high degree of ingenuity, creativity and innovativeness, and where precedent may not exist.
Education & Experience
- 15+ years of relevant experience in biopharmaceuticals, biotech or pharmaceuticals industry, and a Bachelor's degree in science or related fields.
- 10+ 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, which may include managing people managers.
- Extensive knowledge and experience in quality assurance in highly regulated manufacturing environments.
- Broad experience across areas such as CMO QA, Validation, Drug development experience and/or Pharmacovigilance and proficiency of Parenteral, Aseptic and API operations is beneficial.
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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 firstname.lastname@example.org for assistance.
For more information about equal employment opportunity protections, please view the EEO is the Law' poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
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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:
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