Director, Quality

Responsibilities

• Lead the global product quality complaints program as the Global Process Owner (GPO) for the end-to-end complaints process.
• Ensure complaint handling is compliant, efficient, risk-based, and inspection-ready across clinical and commercial products.
• Provide strategic and operational leadership for complaint intake, triage, investigation oversight, trend monitoring, and escalation.
• Drive global harmonization of the complaints process, including procedures, training strategies, metrics, and digital systems.
• Oversee complaint categorization and assess potential safety, regulatory reporting, recall, and manufacturing implications.
• Drive robust complaint trending and signal detection to identify recurring issues and systemic quality concerns.
• Represent the function during regulatory inspections from the FDA, EMA, and other global health authorities.
• Partner with cross-functional stakeholders in Quality Assurance, Manufacturing, Patient Safety, and Regulatory Affairs.
• Lead, coach, and develop a team of quality professionals responsible for complaints management and process governance.

Requirements

• 12+ years of relevant experience with a Bachelor’s degree in science or a related field; or 10+ years of relevant experience with an advanced science degree (MS, MD, PharmD, PhD) or an MBA.
• Proven leadership experience in Quality, Regulatory, or related functions within the pharmaceutical or medical device industries.
• Extensive experience managing complaint handling systems across both pharma and medical device sectors.
• Direct experience with regulatory health authority inspections and audits.
• In-depth knowledge of GMP, cGMP, GDP, QSR, and ISO 13485.
• Strong understanding of Quality Risk Management and global requirements for product quality life-cycle management.
• Excellent verbal, written, and interpersonal communication skills with the ability to influence matrixed teams.

About the Company

Gilead Sciences is a research-based biopharmaceutical company dedicated to delivering life-saving therapies to patients in need. For over 35 years, we have tackled major diseases such as HIV, viral hepatitis, COVID-19, and cancer, working relentlessly to improve lives and ensure global access to essential medications.