Senior Manager, Quality Assurance

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

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

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.

We are seeking a highly motivated individual to join us as a Senior Manager, Quality Assurance for the Gilead La Verne Batch Record Review and Release team. You will work with the team to ensure quality clinical and commercial product is released in a timely manner and in compliance with Quality and Regulatory requirements.

Responsibilities:

• Manages QA personnel, including organizing and prioritizing daily tasks, performing training, and writing performance reviews.

• Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements.

• Manages, prioritizes, and participates in batch record review and release activities, including review of manufacturing, environmental monitoring, and quality control data for in-process and finished products. Responsible for final release of manufactured products.

• Participates in introduction of new clinical/commercial products (e.g., small molecules and biologics) to the site.

• Participates in risk assessments.

• Participates in author, review, and approval of changes to standard operating procedures, specifications, forms, and other controlled documents to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs).

• Participates in site inspection readiness activities.

• Participates in internal and external audits.

• Participates in continuous improvement initiatives.

• Supports generation, and review of metrics and trending data.

• Partner with internal partners to ensure resolution of quality issues.

• Participates in review/approval of Deviations, CAPAs, and Change Management records as required.

• Works on problems that are moderately complex in scope where analysis of situations or data requires in-depth evaluation of various factors. Considerable judgement is required in resolving problems and making routine recommendations.

• Exercises judgement within defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.

Qualifications:

• Bachelors Degree and 8+ years of experience required OR

• Masters Degree and 6+ years of experience required OR

• PhD or PharmD preferred

• Experience with batch record review and release of clinical and/or commercial product preferred.

• Experience with biological product processing, formulation, operations, and/or testing preferred.

• Experience with parenteral and aseptic operations; proficiency or familiarity with Annex 1 requirements.

• Experience across broad areas of Quality Assurance and/or Quality Systems.

• Experience with interacting with regulatory agencies.

• Demonstrated ability to develop, coach and mentor employees.

• Excellent interpersonal, verbal, and written communication skills.

• Knowledge of Risk Management tools (e.g., HACCP and FMEA)

The salary range for this position is: $126,480.00 - $163,680.00. 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.

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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 ApplicantAccommodations@gilead.com for assistance.

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

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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 log onto your Internal Career Site to apply for this job.