Executive Director, Head of Product Quality
About The Position
Gilead Sciences is currently seeking an Executive Director level position to be the leader of the Product Quality Organization, in the Pharmaceutical Development and Manufacturing (PDM) organization. The leader of PQ is a key strategic member of the Quality Leadership Team, reporting to the Head of Global Quality. The position is key in providing guidance and direction for implementation of effective and efficient quality processes associated with product quality, end to end and leads the Product Quality Leader team, Complaints and Annual Product Review teams. The candidate must have demonstrated leadership skills and with in-depth understanding of drug development, commercialization, and lifecycle management, be able to evaluate options and trade-offs and utilize available resources to achieve the most positive impact to the business and be able to partner with leaders in Portfolio Strategy team, Manufacturing, Technical and Analytical functions, Supply Chain, Regulatory CMC, and the wider PDM Quality organization to achieve business objectives. The successful candidate must have proven track records in leading technical teams in a biotech or pharmaceutical development environment and strong knowledge of cGMP quality systems.
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.
Benefits
- company-sponsored medical, dental, vision, and life insurance plans.
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What This Job Offers
Job Type
Full-time
Career Level
Executive
