Senior Director, R&D Quality

Location

California

Posted

1 day ago

Salary

$221K - $314.6K / year

Seniority

Senior

Postgraduate Degree8 yrs expEnglishGoogle Cloud Platform

Job Description

Senior Director, R&D Quality

Gilead Sciences

• Design and implement the Quality Strategy for Oncology, Virology and Inflammation therapeutic areas across the development lifecycle. • Lead and direct Quality assessments across the early and late phase portfolio, conducting comprehensive evaluations that identify risks, assess overall quality health, and guide prioritization of mitigation and improvement efforts. • Lead the analysis and interpretation of Quality data for the presentation and reporting to functional and executive leadership. • Lead and supervise the management of critical and/or complex quality events as well as the assessment of serious breaches. • Ensure the development of robust, comprehensive action plans that proactively address Quality and compliance risks. • Lead Quality activities to support product submissions and responses to Health Authorities. • Establish strong partnership with key functional leaders, including Clinical Development, Clinical Operations, Regulatory Operations, Safety and Clinical Data Sciences. • Generate clear and actionable insights that strengthen the Audit and Inspection Management programs, ensuing oversight activities are focused where they matter most. • Drive implementation of Quality by Design principles in therapeutic area development programs. • Collaborate with cross function therapeutic area leadership, in particular Regulatory, Safety, Clinical Development and Clinical Operations. • Drive risk-based decision making by delivering clear, insightful rationale that reflect sound judgement and deep Quality expertise. • Participate/provide expertise in in licensing and collaboration activities as applicable. • Support management of internal inspection preparation activities and overall readiness throughout program life cycle for Gilead study teams. • Identify and drive continuous quality process improvements through assessment of audit, inspection and quality event outcomes and identification of trends from internal deviations. • Provide guidance and training on relevant GxP regulations and guidelines to cross-functional business partners. • Serve as an expert and provide guidance on and interpretation of global GCP regulations and Gilead standards for internal stakeholders. • Interface with key external Quality organizations for Gilead development partners and collaborations. • Supports overall R&D Quality goals and objectives including but not limited to resource budget and outputs, and line management oversight of the team. • Supervise, develop, train and manage internal staff. This includes fostering a commitment to quality in individuals and a culture of quality within the organization.

Job Requirements

  • Bachelor’s degree with 12+ years; Master’s degree with 10+ years; or PhD with 8+ years of R&D quality assurance compliance experience
  • Must have broad GCP audit and compliance experience
  • Clinical Quality Assurance/Compliance experience in a Bio-pharma sponsor organization required
  • Familiarity with GVP and 21 CFR Part 11 electronic systems and compliance activities is preferred
  • Track record of experience in managing therapeutic area and/or disease specific compliance programs required
  • Experience in implementing principles for Quality Risk Management (ICH Q9, ICH E6 R3) required
  • Experience leading business process improvement projects required
  • Proven effective verbal, written, interpersonal skills to include delivering presentations to executives.
  • Recognized as an expert resource on a range of compliance topics.
  • Management of junior and senior staff.
  • Proficient in Microsoft Office suite.
  • Experience with Inspection and Audit management/CAPA management programs strongly preferred.
  • Excellent organizational and project management skills.
  • Able to lead and mentor effective cross functional teams.

Benefits

  • company-sponsored medical, dental, vision, and life insurance plans
  • discretionary annual bonus
  • discretionary stock-based long-term incentives
  • paid time off

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