Director R&D Quality - Intelligence Compliance & Quality Integration Management

Gilead Sciences, Inc.; Foster City (CA); On-site; USD 210,000 - 273,000; Full time

Job summary

A leading pharmaceutical company is seeking a qualified individual to oversee the R&D Quality Management System. This role involves driving compliance, managing risks, and ensuring effective integration of quality processes. The ideal candidate will have significant experience in regulatory requirements and quality management, contributing to continuous improvement initiatives. Join a team dedicated to creating life-changing therapies and improving global health.

Benefits

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

Bonuses

Stock Incentives

Paid Time Off

Qualifications

• 8+ years experience with PharmD/PhD or 10+ years with MA/MS/MBA.
• Experience in quality or compliance in the pharmaceutical industry.

Responsibilities

• Lead impact assessments for regulatory changes ensuring compliance.
• Support development of GxP intelligence change management program.
• Create and maintain central repository for R&D integration documentation.

Skills

Risk Management

Regulatory Compliance

Communication

Education

PharmD/PhD

MA/MS/MBA

BA/BS

Job description

Apply locations: United States - California - Foster City; United States - New Jersey - Parsippany
time type: Full time
posted on: Posted 11 Days Ago
job requisition id: R0045166

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 ensure access worldwide. 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 discovering and developing life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for passionate and ambitious people ready to make a difference.

We believe every employee deserves a great leader. People Leaders are the cornerstone of the employee experience at Gilead and Kite. As a people leader, you are key to evolving our culture and creating an environment where every employee feels included, developed, and empowered to fulfill their aspirations. Join Gilead and help create possible, together.

Job Description

Position Overview:

This role focuses on two primary accountabilities related to the health and evolution of the Gilead R&D Quality Management System (QMS):
1) Drive intelligence change management activities, including implementation of new legislation for proactive compliance.
2) Serve as R&D Quality integration lead to facilitate effective integration with Gilead’s R&D QMS and support collaboration documentation.

The role involves building and improving core capabilities related to Gilead’s QMS across GLP, GCP, GVP, including audits, inspections, vendor quality, reporting, analytics, documentation, and training. It also involves transitioning external assets into Gilead’s R&D QMS and enabling cross-company QMS interactions. You will develop and maintain systems for change management and integration frameworks, interfacing with Clinical Development, Legal, IT, and Manufacturing teams.

Responsibilities

• Support development and execution of a GxP intelligence change management program and operating framework.
• Mine, analyze, evaluate, and escalate risks associated with emerging intelligence.
• Lead impact assessments and implementation planning for regulatory changes, ensuring compliance and project delivery on time and budget.
• Evaluate SOPs, procedures, data, and reporting to ensure ongoing regulatory compliance and fit-for-purpose processes.
• Contribute to external engagement programs and knowledge hubs to monitor GxP compliance and facilitate industry representation.
• Lead continuous improvement activities on inspection management processes, analyzing data to assess gaps and opportunities for inspection readiness.
• Support inspection readiness and conduct activities as needed.
• Develop communication plans for GxP intelligence changes.
• Create tools and methods for leadership updates.

QMS and Integration Responsibilities

• Create and maintain a central repository for R&D integration documentation, tools, and procedures.
• Develop procedures and tools to support integration activities.
• Advise on quality considerations for integration projects to ensure compliance.
• Coordinate risk assessments and maintain risk registers.
• Develop templates for integration plans and reports.
• Monitor and coordinate quality deliverables for integrations.
• Develop metrics to monitor compliance and completion of activities.
• Ensure proper archiving of records and update the QMS Manual as needed.

Qualifications

Basic Qualifications:

• PharmD/PhD with 8+ years of relevant experience OR
• MA/MS/MBA with 10+ years OR
• BA/BS with 12+ years in the pharmaceutical or related industry.

Preferred Qualifications:

• Degree in life sciences or related field with significant industry experience, especially in quality or compliance.
• Experience advising on regulatory requirements, risk management, and continuous improvement.
• Strong relationship-building skills across R&D and external stakeholders.
• Experience leading external industry groups and excellent communication skills.
• Proven ability to manage large, complex projects and initiatives with measurable outcomes.

Compensation and Benefits

The salary range for this position is $210,375 - $272,250, based on experience, qualifications, and location. Benefits include medical, dental, vision, life insurance, bonuses, stock incentives, paid time off, and more. For details, visit: Gilead Benefits.

Equal Opportunity Employment

Gilead is committed to providing equal employment opportunities and fostering an inclusive environment. We prohibit discrimination based on race, color, religion, national origin, sex, age, sexual orientation, disability, and other protected characteristics. Applicants requiring accommodations can contact: [e-mail].

For more information about your rights, see the 'Know Your Rights' poster.

Additional Information

This role may require travel. Employees should apply via the internal portal if already employed at Gilead.