Sr Director, R&D Quality

Gilead Sciences, Inc. • Foster City, CA

31d • Hybrid

About The Position

R&D Quality is seeking a Senior Director, Quality Operations Excellence Lead to join our R&D Program Quality Team. In this role you will lead and set a strategy for ensuring the execution of Quality Oversight activities for all products in development at Gilead. Through the establishment of standards and promoting best practices, you will drive optimized performance for key focus areas critical to the success of R&D Quality. Acting as trusted business partners you and your team will work closely with R&D Program Therapeutic Area Leads to oversee the consistent performance and outputs of key activities such as study oversight plans, critical quality event management, serious breach assessments, study/program/therapeutic area analytics and Quality Briefs. Reporting to the Executive Director, R&D Program Quality, you will also be a key member of the R&D Quality and Medical Governance Extended Leadership Team advancing a culture of Quality across Gilead. We seek an individual with strong leadership skills, expert drug development and GCP knowledge, and advanced understanding of the application of Quality Risk Management principles. You will be a part of a dynamic global Quality leadership team that strives to be a trusted business partner and promotes a culture of Quality in all we do.

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
• Clinical Quality Assurance/Compliance experience in a Bio-pharma sponsor organization required.
• Proven experience in managing compliance programs required.
• Experience in implementing principles for Quality Risk Management (ICH Q9, ICH E6 R3) required
• Familiarity with GVP and 21 CFR Part 11 electronic systems and compliance activities is preferred.
• 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.
• Ability to travel is approximately 20% required.

Responsibilities

• Design and implement an integrated Quality Operations Strategy for the Gilead R&D portfolio.
• Establish standards, tools & performance indicators for key activities including quarterly metrics & risk reporting for Program/Study Quality Briefs, Due Diligence, Quality Oversight Plans, critical quality event management, serious breach assessment and reporting.
• Lead the analysis and interpretation of key quality data in Program/Study Quality Briefs for the presentation and reporting to functional and executive leadership.
• Lead and oversee lessons learned activities driving continuous improvement.
• Optimize R&D Program Quality performance by implementing a flexible centralized resourcing model for high-demand activities.
• Oversee and lead critical quality event investigations and serious breach assessments.
• Act as point of contact (PoC) for due diligence activities ensuring collaboration with Regulatory and Safety leads.
• Collaborate with Oncology, Virology and Inflammation Program Leads in assessing cross therapeutic area risks.
• Act as PoC for Program Quality for key initiatives within Global R&D Quality and RSQ.
• Providing guidance and training for core quality management capabilities such as risk management, quality event management and issue escalation, and deviation and CAPA management.
• Establish strong partnership with key business stakeholders, including Clinical Development, Clinical Operations, Regulatory, Safety, and Clinical Data Sciences.
• Identify and drive continuous quality process improvements through assessment of audit, inspection and quality event outcomes and identification of trends from internal deviations.
• Serve as an expert and provide guidance on and interpretation of global GCP regulations and Gilead standards for internal stakeholders.
• Supports overall R&D Quality goals and objectives including but not limited to Quality strategy & goals.
• Supervise, develop, train and manage internal staff as needed. This includes fostering a commitment to quality in individuals and a culture of quality within the organization.
• Leads intra or interdepartmental teams such as goal and continuous improvement initiatives.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Industry: Chemical Manufacturing
• Number of Employees: 5,001-10,000 employees