Senior Director, R&D Quality

🔥 0 minutes ago

🏄 California – Remote

🏄 California – Remote

💵 $221k - $314.6k / year

⏰ Full Time

🟠 Senior

👔 Director

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Gilead Sciences

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1987

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Gilead Sciences is a leading biopharmaceutical company that focuses on discovering, developing, and delivering innovative therapeutics for patients with life-threatening diseases. The company is highly recognized for its contributions in virology, particularly HIV and hepatitis, and is actively expanding its therapeutic reach into fields like oncology and inflammation. Gilead has a strong pipeline of medicines, with over 25 products available globally and 50 clinical programs. Known for its commitment to health equity, the company also actively funds HIV research and causes. Gilead's dedication to scientific innovation and health equity aims to tackle the world's most pressing health challenges, improving patient lives globally.

📋 Description

• 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.

🎯 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