Sr Director, External Quality Testing Operations

**Senior Director, External Quality Testing Operations**This role can be based in Foster City, CA or Parsippany, NJGilead 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 Gileads 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 Gileads 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 Gileads 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:Collaborate with Technical and Quality leadership to identify solutions and processes and align with key partners on implementation of new requirements.Provide guidance to the business teams on technical regulatory requirements and lead and assist where needed.Knowledge, Experience and Skills: quality requirements 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. experience and ability to manage Basic Qualifications: 12 - 15 years of relevant experience and a bachelors 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.Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*. For additional benefits information, visit: #J-18808-Ljbffr