Associate Director, Quality – CDS Business Strategy and Operations

Gilead Sciences; Foster City (CA); On-site; USD 182,000 - 236,000; Full time

Job summary

An established industry player is seeking an Associate Director of Quality to lead quality strategy in Clinical Data Science. This pivotal role involves designing and optimizing quality capabilities, ensuring compliance with GCP and regulatory standards, and fostering a culture of continuous improvement. The ideal candidate will have extensive experience in biopharma quality assurance and a strong track record in managing compliance issues. Join a dynamic team dedicated to making a difference in healthcare and be part of a mission-driven organization that values collaboration and innovation.

Benefits

Medical Insurance

Dental Insurance

Vision Insurance

Paid Time Off

Stock-based Incentives

Qualifications

• 10+ years in biopharma quality and compliance.
• Experience with GCP and regulatory requirements.

Responsibilities

• Develop and implement quality strategy for CDS.
• Manage quality review of clinical trial documents.
• Collaborate on audit and inspection activities.

Skills

Quality Assurance

Regulatory Compliance

Risk Management

Clinical Trials

Analytical Skills

Education

BS/BA in Life Sciences

MS/MA in Life Sciences

Tools

Quality Management System (QMS)

Job description

Associate Director, Quality – CDS Business Strategy and Operations

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Associate Director, Quality – CDS Business Strategy and Operations

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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.

Summary

Job Description

The Associate Director, Quality will be responsible for designing, implementing, and optimizing quality capabilities that support the Clinical Data Science (CDS) to drive a culture of continuous improvement and raise awareness about the importance of a Quality Culture and shared accountability for the Gilead R&D Quality Management System (QMS). This role requires an in-depth knowledge of GCP and understanding of regulatory requirements applicable to the conduct of clinical trials. The Associate Director, Quality will partner with key stakeholders in Gilead R&D Quality to enhance quality across the trial portfolio to address compliance issues and conduct risk control and risk mitigation activities.

Job Responsibilities

• Lead in the development and implementation of quality strategy and associated capabilities to support the CDS objectives
• Manage quality review of clinical trial documents, workflows, and outputs within the CDS organization to ensure clinical trials are conducted in compliance with Gilead procedures, GCP and applicable global regulations
• Analyze trends to identify process gaps, improvement opportunities and areas requiring corrective/preventive actions
• Lead new quality focused initiatives focused on new learnings, findings, and observations to continuously improve CDS quality practices and methods
• Work closely with Gilead CDS study team to provide expert advice on compliance issues and risk mitigation actions
• Collaborate with the audit, inspection and CAPA management team within Gilead R&D Quality on internal audits, regulatory agency inspections, risk assessment, deviations and CAPA activities
• Liaison and coordinate with business experts and stakeholders to support resolution of audit outcomes which require further action or response. Partner closely with business units to lead, track and manage corrective actions or risk mitigation activities
• Serve as a Change Champion for Gilead QMS-related communications to the CDS organization consolidating and channeling just-in-time information and resources to prepare the organization for change
• Analyze new regulations and polices with emphasis Good Clinical Practices (GCP) and partner with business experts and stakeholders to update internal documentation and practices accordingly based on areas of impact
• Foster a commitment to quality in individuals and a culture of quality across the CDS organization and with CDS related service providers
  
  

Education And Experience

• A BS/BA degree in life sciences or related field with 10+ years of relevant experience advising business functions in the biopharma industry on quality and compliance requirements, evolving regulations, risk minimization and mitigation, and vendor management OR
• A MS/MA degree in life sciences or related field with 8+ years of relevant experience advising business functions in the biopharma industry on quality and compliance requirements, evolving regulations, risk minimization and mitigation, and vendor management
  
  

Knowledge & Other Requirements

• Experience working across a broad spectrum of quality and compliance activities, including authoring and reviewing SOPs, facilitating internal audits, supporting regulatory inspections, developing and managing CAPAs and deviations, and training others on quality and compliance requirements
• Significant experience participating in cross-functional projects and teams with responsibilities related to clinical trials or other drug development activities
• Familiar with the practice of recording and monitoring quality observations through a Quality Management System (QMS)
• In-depth knowledge of regulatory requirements applicable to the conduct of clinical trials and guidelines (e.g., FDA, EMA, ICH) and related industry standards and trends
• Through knowledge of the drug development process, including all key functions involved in the various stages of drug development from early research through post-marketing
• Strong analytical skills to assess quality issues and lead the resolution in a collaborative manner across functions
• Significant experience advising business function and senior leadership team on quality & compliance requirements, evolving regulation, risk mitigation, and continuous improvement
• Strong track record of cultivating and maintaining strategic relationships and collaboration both internally and externally
  
  

The salary range for this position is: $182,070.00 - $235,620.00. 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

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

• 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 [e-mail] for assistance.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.

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YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

PAY TRANSPARENCY NONDISCRIMINATION PROVISION

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.

Seniority level

• Seniority level

  Not Applicable

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Biotechnology Research and Pharmaceutical Manufacturing

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