Senior Director, Quality Assurance

Location: San Francisco, California US

Notice

This position is no longer open.

Job Number: 1669

External Description:

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
Sr. Director, Quality Assurance

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/

Gilead Sciences is looking for a Sr. Director, Quality Assurance to lead our parenteral team focused on development and commercial products/projects. We are looking for a dynamic leader to provide support for CMC project teams, ensure fulfillment of Quality Functional Site Lead role, support batch record review and product distribution of parenteral products managed by the Foster City QA team. The position will be responsible for continuous improvements in alignment with Quality's vision to continuously drive operational excellence.

Key responsibilities

  • The Sr. Director of Quality Manages QA personnel, including organizing and prioritizing group tasks, performing training, developing personnel 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 global programs, processes and methods to ensure high quality products and compliance with cGMPs, EU GMPs, Annex 1 and GLPs, along with compliance of protocols and safety regulations.
  • Approves manufacturing, environmental and laboratory operations, monitoring and quality control data for in-process and finished products.
  • Responsibilities may include the final release for all manufactured products into Europe and other countries.
    Reviews and approves annual product reviews and training programs regarding all aspects of producing quality products.
    Leads/coordinates investigations, and the development and implementation of corrective and preventative action (CAPA) recommendations related to distribution activities.
  • Oversight of CMO relationships as well as inhouse sterile manufacturing from a quality standpoint
  • Demonstrates an in-depth understanding and application of GMP principles, concepts, practices and standards in the US and internationally.
  • Demonstrates strong knowledge of medical device, 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.
  • Is an experienced auditor with demonstrated acumen in resolving challenging audit situations.
  • Demonstrates excellent verbal, written, and interpersonal communication skills.



Specific Education & Experience Requirements:

  • 10 - 12 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.




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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 careers@gilead.com for assistance.

For more information about equal employment opportunity protections, please view the 'EEO is the Law' poster.

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For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

Job Number: R0013679

Community / Marketing Title: Senior Director, Quality Assurance

Location_formattedLocationLong: San Francisco, California US

 

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