Executive Director, Head of Product Quality

Gilead Sciences•Foster City, CA

4d•Onsite

About The Position

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. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of strong late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases. Working in Quality at Gilead: Quality delivers on Gilead’s commitment to bring life-changing therapies to patients through the robust Quality processes and systems. Our approach is agile, innovative and collaborative and our teams are committed to the successful delivery of safe life-changing therapies.

Requirements

In-depth understanding and application of GMP principles, concepts, best practices, and standards in the US and internationally.
Demonstrated ability to develop and improve complex concepts, techniques, and standards and new applications based on quality principles and theories.
In-depth knowledge in Global requirements/standards for product registration and life-cycle management of product quality.
Extensive knowledge and experience in technology validation/transfer of Drug Substance and Drug Product.
Demonstrated ability to develop solutions to complex problems, which require a high degree of ingenuity, creativity, and innovativeness, and where precedent may not exist.
Excellent verbal, written, and interpersonal communication skills.
Ability to interact with regulatory agencies as needed and possesses the ability to represent Gilead in public forums.
Demonstrated experience and ability to manage team of highly technical staffs.
Expert in managing resources to address competing projects and timelines.
15+ years of relevant experience and a bachelor’s degree in science or related fields; or 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 leadership experience in a complex organization a must.
Deep knowledge and experience in quality assurance in a highly regulated manufacturing environment.
Biopharmaceutical or Pharmaceutical experience a must.

Nice To Haves

Broad experience across contract organization management, quality assurance, validation, drug development and product lifecycle management preferred.
Experience with different pharmaceutical modalities, e.g., active pharmaceutical ingredients, parenteral, biologics, and medical device preferred.

Responsibilities

Execute an integrated and sustainable product quality strategy and priorities for Gilead’s clinical and commercial products based on the value proposition for Gilead (Integrity, Inclusion, Teamwork, Accountability, Excellence) and available SMEs.
Develop processes to communicate learnings and drive any related activities for Gilead’s clinical and commercial products in support of a robust compliant lifecycle for the programs.
Develop a process for exchange of lessons learned across multiple company representatives and identify opportunities for Gilead’s process improvements.
Collaborate with Quality leadership to identify solutions and processes and align with key partners on implementation of new requirements.
Implement continuous improvement initiatives to drive quality programs and ensure maximum productivity.
Ensure systems are world-class and meet the needs of all internal and external constituencies with an emphasis on process, quality, productivity, budget control, and profitability.
Develop, implement, and monitor quality programs, policies, and procedures to ensure compliance with GxP standards, corporate policies, FDA, EMA, and other regulatory body regulations and guidelines.
Set and drive compliance to department, site and global KPIs.
Evaluate all current quality systems and processes and recommend and implement appropriate enhancements and trainings to ensure the achievement of Gilead long-term objectives.
Professional organization engagement and representation; benchmarking in industry networks.
Provide guidance to the business teams on technical regulatory requirements and lead and assist where needed.
Participate on various governance committees.
Contribute to and review regulatory dossier sections and information requests (including but not limited to IND, IMPD, BLA, NDA, MAA, post-approval changes and post marketing commitments).
Conduct regular review and assessment of regulatory intelligence and communicate any concerns, trends, gaps, alerts to Quality management in a timely fashion.
Think and act globally to anticipate potential problems and risks related to regulatory compliance expectations.