Assoc Director, R&D Quality (Foster City)

Associate Director, GVP Audits page is loaded

Associate Director, GVP Audits

Apply remote type Onsite - Hybrid Eligible locations United States - California - Foster City United States - New Jersey - Parsippany time type Full time posted on Posted Today job requisition id R0046703

At Gilead, were creating a healthier world for all people. For more than 35 years, weve 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 worlds biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gileads 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 were 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

The Associate Director, Good Pharmacovigilance Practice (GVP) Audits, serves as a key role within Gileads R&D Quality Organization. This role is responsible for executing internal GVP audits, supporting E-System/Digital audits, as well as, support or lead complex audits across the broader R&D, vendor, and pharmacovigilance workstreams.

This position requires close collaboration with cross-functional stakeholders, including R&D Quality Business Partners (QBPs), Inspection Management, Patient Safety, and other relevant departments. In partnership with GCP and E-System Audit groups, this role helps shape, communicate, and implement the R&D Quality Annual Audit Program.

Reporting to the Head of GVP Audits, the Associate Director contributes to the strategic development and operational execution of the GVP audit function. Responsibilities include developing and improving audit tools and procedures, ensuring the effectiveness of corrective and preventive actions (CAPAs), and providing updates through quality forums and internal communications regarding audit outcomes and CAPAs.

Beyond auditing, this role supports regulatory inspections, readiness, and partners with the R&D Quality Extended Leadership team with responsibilities for helping build and shape quality capabilities, enhance process improvements and transparency. This is a quality assurance role, helping maintain global compliance, reinforcing audit excellence, and ensuring the consistent delivery of high-quality audits, supporting Gileads mission to advance transformative therapies.

ABOUT R&D QUALITY

Gilead R&D Quality is a phenomenal place to develop your skills and expertise. Our strong pipeline of therapies will provide you opportunities to be challenged and stretched while supported and developed by our diverse and expert team. We are a committed team of highly skilled Quality professionals dedicated to helping deliver life-saving therapies for unmet needs. We bring our passion for science, discovery, and creative thinking into everything we do.

We are an inclusive and diverse community, who are supported by strong leaders that are committed to giving each of us a voice while achieving our mission. Our collaborative and supportive structure will help you develop your skills, experience, and your career. Are you ready to explore how you can play a vital role on the team and help deliver life-saving therapies to patients around the world?

PRIMARY RESPONSIBILITIES

GVP Audit Program :

• Accountable for the successful oversight and completion of a broad spectrum of GVP audit activities and deliverables across affiliates, partners, vendors and internal PV processes.
• Lead internal R&D quality audits for assigned R&D groups or locations.
• Provide subject matter expertise and support to project teams.
• Develop, drive, or support continuous improvements in R&D quality processes, systems, and standards to meet regulatory requirements and organizational goals while contributing to the overall quality mindset and culture.

GVP Audit Operations:

• Act as a primary point-of-contact to assigned R&D groups and advise on: GVP regulatory requirements, changing legislation, and relevant Gilead policies and procedures supporting audits and pharmacovigilance activities.
• Execute on the strategic audit plan. Plan, schedule, and conduct GVP audits in accordance with the audit plan.
• Prepare and deliver high quality audit reports and follow up on CAPAs to ensure timely resolution and CAPA effectiveness.
• Collaborate with R&D Quality Business Partners and stakeholder SMEs.
• Support risk assessment activities, in partnership with risk program and SMEs.
• Support the overall inspection readiness of the GVP Audit program, including preparation for and participation in inspections.
• Oversee and manage the work of contractor auditors, ensuring effective oversight and completion of assigned tasks.
• Track resources and ensure compliance with regulatory timelines and quality standards for audit deliverables.
• Support the E-Systems/Digital Audit program, as needed, ensure adherence to regulations and industry best practices, and maintain an external network to assure current understanding of industry trends.
  

Quality Management:

• Evaluate, and advise on systems, processes, documentation, and CAPAs for assigned R&D groups to ensure ongoing compliance and alignment with regulatory requirements.
• Play a key role in preparing the assigned R&D groups for inspections or external reviews including ensuring alignment with Gilead business needs and regulatory requirements.
• Stay current with evolving global PV regulations and guidance.
• Support the development of GVP Audit material/insights for quality forums and management reviews.
  

Training & Development:

• Develop and deliver on GVP training for assigned R&D groups, ensuring teams are equipped with the knowledge and skills to maintain compliance and audit excellence.
• Establish relationships with key stakeholders, including contract auditors, cross-functional leaders, and regulatory teams to facilitate training, knowledge sharing and continuous improvement initiatives.

BASIC QUALIFICATIONS:

• PharmD/PhD with 2+ years of relevant experience
  OR
• MA/MS/MBA with 8+ years of relevant experience
  OR
• BA/BS with 10+ years of relevant experience or advanced degree in life sciences/related fields with significant experience in quality compliance or related fields.

PREFERRED QUALIFICATIONS:

U.S. Education & Experience

• BA/BS or advanced degree in life sciences or related field with significant relevant experience in the biopharma industry, including significant relevant experience working in quality, compliance, pharmacovigilance, or a related field. Extensive experience leading GVP audits, in the biopharma or related industry.
• Proficiency in pharmacovigilance regulatory requirements (Global) is a must.
• Expert-level experience working with GVP processes and systems is required.
• Proficient in GxP Auditing with a successful track record of leading pharmacovigilance audits.
• Broad experience participating in cross-functional projects and teams with responsibilities related to pharmacovigilance and quality system activities.
• Significant experience leading quality, compliance or related projects in the biopharma or related industry, including leading continuous improvements such as new or updated business processes, systems and/or SOPs.
• Experience working with total quality management methodologies, such as Lean Six Sigma, is preferred.
• Certification as a Quality Auditor is preferred.
  

Knowledge & Other Preferred Requirements

• Expert knowledge of the drug development process and GVP, including global regulations (FDA, EMA, ICH) and their application to cross-functional drug development.
• Proficient in GxP Auditing with a successful track record of leading pharmacovigilance audits.
• Thorough knowledge of standards, systems, policies, and procedures that enable QMS operations and compliance within the biopharma industry, specifically those related to GVP.
• Proven effectiveness in making appropriate decisions independently for relatively complex projects or related issues, as evidenced by past decision-making track record.
• Proven abilities to assume increasing scope and complexity, as evidenced by past successes with team and project leadership, strategic cross-functional partnering, and key contributions to strategy, operational and infrastructure development.
• Advanced business knowledge and analytical skills, as evidenced by strengths in assessing complex information and understanding the quality and compliance implications on the portfolio.
• Track record of successful interaction and collaboration with other functions and with senior leadership, on key projects and deliveries supporting quality and compliance.
• Demonstrates ability to execute against the strategic and tactical objectives provided by senior leaders both within Quality and outside of the function.
• Demonstrates ability to integra]]>