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.
