Director, R&D Quality Inspection Management Lead

4 weeks ago

Cambridge, Cambridgeshire, United Kingdom Gilead Sciences Full time

Job Description

At Gilead Sciences, we're committed to creating a healthier world for all people. For over 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19, and cancer, working relentlessly to develop therapies that improve lives and ensure access to these therapies across the globe. Our mission requires collaboration, determination, and a relentless drive to make a difference.

Every member of our team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for passionate and ambitious individuals ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone of the employee experience at Gilead Sciences and Kite. As a People Leader now or in the future, you're the key driver in evolving our culture and creating an environment where every employee feels included, developed, and empowered to fulfill their aspirations.

Position Overview:

You'll act as a primary point-of-contact for R&D Quality inspection management and serve as an inspection readiness ambassador, supporting the drive to a continuous improvement company culture. You'll lead the development and maintenance of a comprehensive and connected framework for continually improving inspection management, supporting R&D personnel with readiness, preparation, conduct, and follow-up for GCP, GLP/GCLP, and GPV inspections by regulatory health authorities.

You'll typically represent Gilead Sciences in regulatory inspections as a lead representative and point-of-contact for regulatory agencies. You'll collaborate cross-functionally to ensure Gilead Sciences' ongoing regulatory compliance and R&D GxP quality operations in accordance with our Quality Management System (QMS) and related policies and procedures.

Key Responsibilities:

  • Manage the effective execution and oversight of R&D inspection activities and deliverables, including establishing standards and processes for defining inspection readiness, preparation, and conduct.
  • Develop and deliver inspection-specific GxP training for assigned R&D personnel.
  • Build relationships and a network of cross-functional stakeholders to promote and enhance inspection readiness.
  • Contribute to the generation and continuous improvement of Gilead Sciences' R&D inspection preparation tools.
  • Prepare and lead instructor-led training of R&D personnel in preparation for regulatory agency inspections.
  • Lead and advise on responses to regulatory agency inquiries and inspections, coordinating a united company response.
  • Analyze, consolidate, and integrate prior Gilead Sciences and external intelligence to shape R&D inspection readiness.
  • Coordinate inspection management horizon scanning, tracking, and archiving activities.
  • Contribute to metric generation and analysis across inspections to identify and respond to emerging trends and potential risks.

GxP Regulatory Compliance, Intelligence, and Change Management:

  • Support the development and execution of a compliance (GxP) intelligence change management program and operating framework.
  • Mine, analyze, evaluate, and escalate potential risks associated with emerging intelligence.
  • Evaluate SOPs, other procedures, data, and reporting of assigned R&D groups/locations to ensure ongoing regulatory compliance, R&D quality, and fit-for-purpose to both Gilead Sciences' business needs and changing regulatory requirements.
  • Play a role in preparing assigned R&D groups/locations for changes to regulations or other requirements and associated continuous improvement initiatives.

Leadership:

  • Provide collaborative matrixed leadership to project and inspection teams.
  • Typically lead and manage direct reports, hiring, developing, and retaining diverse top talent on the team.
  • Set clear and elevating goals for the team and individual direct reports, coaching them on performance, development, and career interests.

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