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Director, Quality Site Lead
Director, Quality Site LeadGilead • San Mateo, CA, US
Director, Quality Site Lead

Director, Quality Site Lead

Gilead • San Mateo, CA, US
21 hours ago
Job type
  • Full-time
Job description

Director, Quality Site Lead

Gilead's mission is to discover, develop, and deliver therapies that will improve the lives of patients with life-threatening illnesses worldwide.

We are seeking a Director, Quality Site Lead located in Foster City, CA.

Job Functions :

  • Primary Pharmaceutical Development and Manufacturing (PDM) Quality contact accountable for proactive quality oversight for assigned Strategic Gilead CXO partners / sites.
  • Assure CXOs meet Gilead's quality, regulatory and compliance standards, to ensure a sustainable delivery of quality products to patients.
  • Key member of Business Review Meetings with CXO as Quality's voice for the contract organizations' oversight. Maybe member or backup member of Joint Steering Committee.
  • Ensure contract manufacturers are compliant and ready for regulatory inspections and monitor progress during inspection. Support onsite inspections to ensure compliance and readiness, as needed.
  • Accountable for multiple external QA functions, including quality events, validation, and release / disposition.
  • Partner with internal stakeholders such as Global External Manufacturing, Global Supply Chain, Pharmaceutical Development, and Reg CMC, to identify solutions and processes and align with key partners on implementation of new requirements; proactively address.
  • Lead escalations for critical quality issues.
  • Evaluate current quality systems and processes and recommend and implement appropriate enhancements and trainings to ensure the achievement of Gilead long-term objectives.
  • Monitor CXO site trends, holding CXO accountable to established performance criteria and QAG requirements.
  • Travel to CXO site(s) to provide Quality oversight of critical manufacturing activities, as required.
  • Ensure GMP documentation is accurate and compliant with internal and external standards and requirements.
  • Provide guidance to the business teams on regulatory requirements and assist where needed.
  • Establish and foster meaningful Quality to Quality relationships between Gilead and CXOs.
  • Conduct regular review and assessment of regulatory intelligence and communicate any concerns, trends, gaps, alerts to Quality management in a timely fashion.
  • Partner with Manufacturing, Development, Global Supply Chain, Global QC and Outsourcing to deliver on the production plan.
  • Think and act globally to anticipate potential problems and risks related to regulatory compliance expectations.
  • May back up Pillar Lead, as needed.
  • Champion Quality Risk Management, identifying key risks impacting CXO performance.
  • Ensure PAI / PLI Readiness for assigned CXO sites.
  • Up to 20% travel based on strategic plan.
  • Manages a team of Quality Professionals.

Knowledge, Experience and Skills :

  • Knowledgeable in quality requirements pertaining to manufacturing, testing, packaging, labeling, facility, utility, equipment and process validation, cleanroom classification and qualification, new product introduction, multi-product facility control, contamination control strategy, technology transfer, contract operations, product release, disposition, and distribution.
  • 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.
  • Knowledgeable in Global requirement / standards for product registration and life cycle management of product quality.
  • 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.
  • Expert in prioritizing workload to address competing projects and timelines.

    • Basic Qualifications :

  • 12+ 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 experience leading, developing and managing people.
  • Knowledge in technical and regulatory requirements pertaining to manufacturing, testing, product lifecycle management, and outsourced operations a must.
  • Biopharmaceutical or Pharmaceutical experience a must.
  • Prior experience leading contract manufacturing / testing operations or overseeing contract manufacturing operations a must.
  • Significant experience with different pharmaceutical modalities, e.g., active pharmaceutical ingredients, parenteral, biologics, and medical device preferred.
  • Prior people management experience required.
  • Broad experience across several areas like CMO QA, Validation, Drug development experience, packaging / labeling and understanding of Parenteral, OSD, and Biologics.

    • People Leader Accountabilities :

    Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.

    Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.

    Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.

    The salary range for this position is : $210,375.00 - $272,250.00. 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.

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