Executive Director, Quality Assurance Biologics

Location
Foster City, California
Salary
We offer a competitive salary and benefits.
Posted
May 27, 2021
Closes
Jun 26, 2021
Category
Other
Position
Director, Executive
Education
MD, MD / PHD, MS, PHD
Hours
Full Time

We want the determined, the big dreamers, the hopeful explorers, the we've-got-this-ers. Because those are the kind of people who are best able to make an impact for people with cancer. So, what’s missing? Just someone like you.

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 be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives.

 

Job Responsibilities

  • 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.

 

We offer a competitive salary and benefits package.  Apply today at Executive Director, Quality Assurance Biologics (myworkdayjobs.com)

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