Director - Product Quality Complaints

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead’s 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 the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description Director, Product Quality Complaints Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of strong late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases. Working in QA at Gilead: Quality Assurance delivers on Gilead’s commitment to bring life-changing therapies to patients through the robust QA processes and systems. Our approach is agile, innovative and collaborative and our teams are committed to the successful delivery of safe life changing therapies. Job Summary: The Director, Product Quality Complaints is responsible for leading the global product quality complaints program and serving as the Global Process Owner (GPO) for the end-to-end complaints process across the enterprise. This role ensures complaint handling processes are compliant, efficient, risk-based, inspection-ready, and consistently executed across clinical and commercial products, markets, and manufacturing networks.The incumbent provides strategic and operational leadership for complaint intake, triage, investigation oversight, trend monitoring, escalation, reporting, and associated quality system governance. As Global Process Owner, this leader is accountable for the design, standardization, performance, continuous improvement, and global harmonization of the complaints process, including related procedures, training strategy, metrics, roles/responsibilities, and enabling digital systems. This role can be based out the Gilead Foster City, CA site or our Parsippany, NJ site. This role partners closely with cross-functional stakeholders across Quality Assurance, Manufacturing , Patient Safety, Patient Access Solutions, Medical Information, and the wider PQM Quality organization to ensure timely, scientifically sound, and compliant complaint management that protects patients, customers, products, and the company. Job Functions: Lead the global quality complaints function, ensuring compliant intake, evaluation, documentation, investigation oversight, closure, and escalation of product quality complaints. Ensure complaints are managed in accordance with applicable global regulations, company quality standards, and internal procedures (e.g., 21 CFR 211.198, EU GMP Chapter 8, ICH Q10, 21 CFR 820.198, 803 (MDR), and EU MDR/IVDR vigilance requirements) Oversee complaint categorization, prioritization, and routing to ensure timely and appropriate action. Ensure product quality complaints are assessed for potential safety, regulatory reporting, recall, field action, and manufacturing investigation implications. Support regulatory reporting decisions, including Field Alert Reports (FARs), Biological Product. Drive robust complaint trending and signal detection to identify recurring issues, emerging risks, and systemic quality concerns. Serve as the Global Process Owner for the end-to-end complaints process, accountable for process design, governance, standardization, and performance across the enterprise. Establish and maintain the global complaints process framework, including policies, standards, procedures, process maps, escalation pathways, and role clarity. Define global process requirements, critical controls, and minimum expectations to ensure consistent execution across sites, regions, affiliates, and third parties. Own end-to-end process performance using defined KPIs/KQIs (e.g., cycle time, on-time closure, investigation effectiveness, recurrence, backlog, quality of records, complaint trending, and escalation metrics). Lead process reviews and governance forums to assess process health, compliance, capacity, and opportunities for continuous improvement. Maintain inspection readiness and represent the function during FDA, EMA, and other global regulatory inspections. Partner with Quality Assurance, Regulatory Affairs, Pharmacovigilance, Medical Affairs, Manufacturing, and R&D. Align complaint processes with pharmacovigilance systems where adverse events overlap. Support product quality reviews and management review processes. Analyze complaint process performance data and trends to identify bottlenecks, recurring failure modes, training gaps, and system improvement opportunities. Lead strategic improvement initiatives to strengthen the effectiveness, efficiency, and control of the complaints process. Partner with Quality Systems and IT to define business requirements and optimize digital tools/workflows supporting complaint management. Establish trending and signal detection methodologies across product lines. Use statistical tools to identify emerging quality or safety signals. Lead, coach, and develop a team of quality professionals responsible for complaints management and/or process governance. Establish clear expectations for performance, accountability, and development. Perform work that requires independent decision making and the exercise of independent judgment. Serve as the delegate for direct manager, as needed, for meeting and decision making. Knowledge, Experience and Skills: In-depth understanding and application of GMP principles, concepts, best practices, and standards in the US and internationally. Strong knowledge of cGMP, GDP, QSR, ISO 13485 and Pharmacovigilance interfaces (desirable). Demonstrated ability to develop and improve complex concepts, techniques, and standards and new applications based on quality principles. In-depth knowledge in Global requirements/standards for life-cycle management of product quality. Skilled at managing multiple projects and timelines and to facilitate meetings. In-depth understanding and execution of Quality Risk Management. Ability to track and follow up on actions. Excellent in verbal, written and interpersonal communication skills. Ability to work in a team-oriented approach to address complex issues in a scientifically sound and compliant way. Ability to lead and influence a matrix-based cross-functional team. Critical and strategic thinking skills and ability to provide pragmatic, risk-based, and phase appropriate guidance and decision-making even when quality and compliance requirements are not well-defined. Basic Qualifications: Prior Quality leadership in Quality, Regulatory, or related functions in pharma and/or medical devices. Demonstrated experience managing complaint handling systems across both sectors. 12+ years of relevant experience and a Bachelor’s degree in science or related fields; or 10+ years of relevant experience and an advanced science degree such as MS, MD, PharmD, PhD or an advanced business degree such as an MBA. Demonstrated experience and knowledge in quality assurance in a highly regulated manufacturing environment. Direct experience with regulatory health authority inspections and audits. The salary range for this position is: Bay Area: $210,375.00 - $272,250.00. Other US Locations: $191,250.00 - $247,500.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. 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*. For additional benefits information, visit: * Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans. For jobs in the United States: Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex , age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact for assistance. For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law. Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team. Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion. For Current Gilead Employees and Contractors: Please apply via the Internal Career Opportunities portal in Workday.