Senior Director, Quality Assurance

Location
San Dimas, CA, United States
Posted
Feb 13, 2021
Ref
2122792
Required Education
Bachelors Degree
Position Type
Full time
Senior Director, Quality Assurance
United States - California - San Dimas

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. Gilead's 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 company's five core values. That's 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

Working in QA at Gilead:

Quality Assurance delivers on Gilead's commitment to bring life-changing therapies to patients through the robust QA processes and systems. Our approach is agile, innovative and collaborative and our teams are genuinely committed to the rapid delivery of safe life changing therapies. As part of the broader Pharmaceutical Development & Manufacturing (PDM) team you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. You will see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through on-going development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining QA within PDM, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.

Meet the worldwide QA Team: https://qualityassurance-careers.gilead.com/

Senior Director, QA

Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will lead the Quality Systems function and collaborate cross-functionally with Manufacturing, QC, Technical Services, Supply Chain, Engineering, Regulatory CMC, to ensure a robust quality systems and maintain a high level of cGMP compliance for commercial and clinical drug product manufacturing while building teams and developing people to create an inclusive culture of quality excellence.

Key Responsibilities:
  • Manages QA personnel, including organizing and prioritizing group tasks, performing training, and writing performance reviews.
  • Performs a wide variety of activities to ensure compliance with quality systems, quality procedures, quality policies and applicable regulatory requirements, to facilitate compliance with regulatory agencies, customer and MA holder requirements.
  • Develops, implements, qualifies and maintains programs, processes and methods to ensure high quality products and compliance with cGMPs, including investigation/CAPA program management, audit program management, GMP change management, documentation control/practices, records management and continuous improvement to improve quality, reliability, productivity and efficiency.
  • Review and approve relevant sections of regulatory filings.
  • Reviews and approves annual product quality reviews and GMP training programs regarding all aspects of producing quality products.
  • May lead/coordinate investigations, and the development and implementation of corrective and preventative action (CAPA) recommendations related to GMP manufacturing activities.


Knowledge, Experience, and Skills:
  • 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.
  • Deep knowledge and experience in quality assurance in a highly regulated manufacturing environment.
  • Prior people management experience.
  • Broad experience across areas like CMO QA, Validation, Drug development experience and/or Pharmacovigilance and understanding of Parenteral, Aseptic and API operations is beneficial.
  • Biopharmaceutical or Pharmaceutical experience preferred.
  • Demonstrates an in-depth understanding and application of GMP principles, concepts, practices and standards in the US and internationally.
  • Demonstrates strong knowledge of aseptic processing, solid dose and general pharmaceutical manufacturing.
  • Demonstrates substantial knowledge of industry best practices and trends.
  • Is comfortable interacting with regulatory agencies as needed and possess the ability to represent Gilead in public forums.
  • Demonstrates acumen in resolving challenging audit situations.
  • Demonstrates excellent verbal, written, and interpersonal communication skills.


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 careers@gilead.com for assistance.

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:
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