Sr Director, External Quality Testing Operations

Senior Director, External Quality Testing Operations

This role can be based in Foster City, CA or Parsippany, NJ

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 PDM Global Quality at Gilead:

Pharmaceutical Development & Manufacturing (PDM) Global Quality delivers on Gilead’s commitment to bring life-changing therapies to patients through 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.

Job Summary:

Gilead Sciences PDM External Quality is currently seeking a leader at the Senior Director level to lead a team of over 50 Quality Professionals to provide quality oversight of GMP activities at Gilead’s contract testing organization global network supporting the release, stability and characterization testing to enable clinical and commercial product submission, release and distribution.

• Being a member of the External Quality Leadership team, the successful candidate is expected to work collaboratively with internal and external networks to continually improve Gilead’s oversight model of contract testing organization global network and ensure manufactured products are safe and effective.

• The successful candidate must have demonstrated leadership skills and extensive working knowledge of managing outsourced testing operations, from site selection, qualification, scheduling, sample shipment, monitor adherence to schedule performance, as well as providing quality oversight for laboratory investigations, and ongoing monitoring of method performance, capacity and technical capability at the contract testing laboratories.

• The successful candidate must have prior leadership experience at contract testing organizations or have extensive experience overseeing contract testing organizations.

• The successful candidate must be extremely familiar with applicable regulations and requirements with outsourced operations and clarity of the role and responsibilities between market authorization holder and contract testing organizations.

• The successful candidate must possess strong communication, influencing and negotiation skills, 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 different PDM functions including Product and Portfolio Strategy, Global Manufacturing, Supply Chain, Regulatory CMC, and the wider Quality organization to achieve business objectives.

• The successful candidate must have proven track records in leading different Quality Control functions in a biotech or pharmaceutical development environment and strong knowledge of cGMP laboratory quality system and have extensive experience in managing audits, inspections and health authority interactions.

Job Functions:

• Execute an integrated and sustainable external quality control testing strategy 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 quality control testing activities for Gilead’s clinical and commercial products in support of a robust compliant method lifecycle management program.

• Develop a process for exchange of lessons learned across multiple company representatives and identify opportunities for Gilead’s process improvements.

• Collaborate with Technical and Quality leadership to identify solutions and processes and align with key partners on implementation of new requirements.

• Implement continuous improvement initiatives to drive quality control testing programs and ensure maximum productivity. Ensuring 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 control testing 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 control testing systems and processes and recommend and implement appropriate enhancements and training 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 in different internal business and technical forums as Quality’s voice for contract testing organizations’ oversight.

• 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.

• Approximately 20% travel is expected.

Knowledge, Experience and Skills:

• Expert in quality requirements pertaining to outsourced testing operations and contract testing laboratory design, operations and maintenance, with strong emphasis on data integrity.

• 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 of Global requirements/standards for product registration and life-cycle management of product quality control testing.

• 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 is needed and possesses the ability to represent Gilead in public forums.

• Demonstrated experience and ability to manage team of highly technical staff.

• Expert in managing resources to address competing projects and timelines.

Basic Qualifications:

• 12 - 15 years of relevant experience and a bachelor’s degree in science or related fields; or 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.

• Prior leadership experience in a complex organization a must.

• Expert knowledge in technical and regulatory requirements pertaining to laboratory controls and outsourced testing operations is a must.

• Biopharmaceutical or Pharmaceutical experience a must.

• Prior experience leading contract testing operations or overseeing contract testing operations is a must.

• Experience with testing operations in different pharmaceutical modalities, e.g., parenteral, biologics, oral solid dosage, and medical device preferred.