Associate Director, R&D Corrective Actions & Preventive Actions (CAPA) Operations Management

Description

At Gilead we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth, and retention of talent, and empower teams to align and achieve goals.

JOB DESCRIPTION

The Associate Director of R&D CAPA (Corrective and Preventive Actions) Operations Management is responsible for overseeing the R&D CAPA program and associated processes, ensuring its effectiveness and continuous improvement.

This role involves managing CAPA administration, CAPA training, setting record standards, and maintaining high-quality standard for records and data.

The successful candidate will collaborate with various business areas, lead strategic process improvement projects, support quality forums, and establish CAPA operational measures to ensure the organization’s compliance and quality objectives are met.

This role reports into the R&D Quality Issue Management function, which is responsible for driving the integration and peak performance of R&D’s Quality Management System elements of Deviation, CAPA, and Escalation across Clinical Development and Post-Marketing.

PRIMARY RESPONSIBILITIES

Lead the R&D CAPA program, ensuring adherence to regulations and industry best practices.

Develop and maintain CAPA procedures, policies, and documentation specific to R&D activities.

Establish a continuous improvement program for CAPA operations, driven through performance measures and lesson’s learned opportunities.

Implement, monitorand report CAPA performance measuresat senior leadership meetings and quality forums including connections to continuous improvement and overall return on investments.

Team Lead for CAPA Operations, includes management of both employees and contractors.

Collaborate with cross-functional teams to develop and implement effective and timelyCAPAs.

Approve all R&D originating CAPA Plans and approve all CAPA closures.

Monitor the effectiveness of implemented CAPAs through regular follow-ups.

Support business and investigation teams on quality issues / events investigations.

Interface with internal and external stakeholders, including presenting at appropriate engagements, building visibility into R&D’sCAPA strategy and overall impact on QMS performance.

Responsibleto the continued maturity of the CAPA program, including quarterly report out to senior leadership through management reviews.

Prepare for and support regulatory inspections and audits related to R&D CAPA activities / operations.

Stay informed of regulatory changes and industry trends affecting R&D quality management.

Collaborate with departments across R&D to ensure effective integration and use of CAPA system and procedures.

Support the development and training of internal staff, including fostering a commitment to quality in individuals and a culture of quality within the organization.

Develop and deliver training and learning programs related to CAPA processes and quality systems for R&D staff.

Mentor and coach R&D team members on effective CAPA management and problem-solving techniques.

BASIC QUALIFICATIONS

Bachelor’s degree in a relevant field (e.g., Biotechnology, Biochemistry, Molecular Biology, Engineering). Advanced degree preferred.

Minimum of 8-10 years of experience in the biotechnology or pharmaceutical industry, with a focus on CAPA management and Quality Systems.

Strong knowledge of GxPregulatory requirements (FDA, EMA, ICH) and industry standards.

Proven track record in lean six sigma, total quality system or similar methodologies.

Experience in leading investigations, root cause analysis, and CAPA implementation within an R&D / Manufacturing environment.

Excellent analytical, problem-solving, and decision-making skills.

Strong leadership and project management abilities.

Excellent communication and interpersonal skills.

Ability to work effectively in a fast-paced, dynamic environment.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives.

Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible

ABOUT R&D QUALITY

Gilead R&D Qualityis 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?

The salary range for this position is : $177,905.00 - $230,230.00. 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.

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As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, 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.