Gilead Sciences Inc

Sr. Quality Assurance Specialist

Gilead Sciences Inc • $123K — $160K *
La Verne, CA 91750In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
1 month ago
Job Overview by Ladders

Qualifications

  • Bachelor's Degree with 6+ years of experience, Master's Degree with 4+ years, or PhD/PharmD with no experience required.
  • Proficiency in parenteral and aseptic operations; familiarity with Annex 1 requirements.
  • Broad experience in Quality Assurance and/or Quality Systems.
  • Experience interfacing with regulatory agencies.
  • Strong verbal and written communication skills.
  • Knowledge of Risk Management tools like HACCP and FMEA.

Responsibilities

  • Manage and prioritize batch record review and release activities for products.
  • Participate in the introduction of new clinical and commercial products at the site.
  • Conduct risk assessments related to quality assurance activities.
  • Author, review, and approve changes to quality documents for compliance with GMPs.
  • Engage in site inspection readiness activities and participate in internal/external audits.
  • Lead continuous improvement initiatives within the quality assurance framework.
  • Generate and review quality metrics and trending data.

Benefits

  • Company-sponsored medical, dental, and vision insurance plans.
  • Eligibility for annual discretionary bonus and stock-based incentives.
  • Paid time off to support work-life balance.
  • Opportunities for professional development and growth.
Full Job Description
Job Description

AtGileadour pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers.

We set and achieve bold ambitions in our fight against the world27s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come.As aSenior Quality Assurance Specialist at Gilead you will have the following responsibilities:

  • 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 as needed.

  • 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 scientific routine recommendations.

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

Requirements:

  • Bachelors Degree and 6+ years of experience required OR

  • Masters Degree and 4+ years of experience required OR

  • PhD or PharmDwith 0+ years of experience

  • 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.

  • Excellent interpersonal, verbal, and written communication skills.

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

Preferred Qualifications:

  • Advanced degree (Masters or PhD/PharmD) is preferred

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

  • Experience with medical devices preferred

  • Experience with biological products

People Leader Accountabilities:

  • Create Inclusion -knowingthe business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.

  • Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employeesare receivingthe feedback and insight needed to grow,developand realize their purpose.

  • Empower Teams - connect the team to the organization by aligning goals, purpose, and organizationalobjectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.

The salary range for this position is: $123,930.00 - $160,380.00. 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.

About Gilead Sciences Inc

Gilead Sciences is a research-based biopharmaceutical company that discovers, develops, and commercializes innovative medicines in areas of unmet need. With each new discovery and experimental drug candidate, they seek to improve the care of patients suffering from life-threatening diseases. Gilead's primary areas of focus include HIV/AIDS, liver disease, and serious cardiovascular and respiratory conditions.

Gilead Sciences Inc Careers

Join the vibrant team at Gilead Sciences Inc, a leader in the biopharmaceutical industry known for its innovative approach to healthcare. At Gilead, we are committed to advancing the care of patients around the globe through rigorous science and research.

Work You’ll Do

Embark on a career journey with Gilead Sciences Inc, where job opportunities abound in a variety of fields, from scientific research to marketing and sales. Our team is dedicated to fostering an environment of diversity and inclusion, where every employee can thrive.

Innovate and Lead

At Gilead, innovation is at the core of everything we do. Join us and contribute to our mission of saving lives through advanced treatments and cutting-edge medicine. Our leadership is committed to nurturing professional growth, making Gilead an ideal place for those who aim to lead and innovate in the healthcare industry.

Grow Your Career

Gilead Sciences Inc offers a wealth of career advancement opportunities. With personalized career development programs, employees are encouraged to pursue their professional interests and expand their skills. Whether through on-the-job learning, formal training, or leadership development, we provide the tools necessary for long-term career growth.

Be Part of Our Team

Our team at Gilead Sciences Inc is composed of passionate, curious, and solution-driven professionals. By joining us, you’ll collaborate with some of the brightest minds in the industry. Our culture promotes teamwork and an interdisciplinary approach to problem-solving, making our workplace dynamic and innovative.

Internship and Employment Opportunities

Start your career with Gilead through our internship programs, which offer hands-on experience in biopharmaceutical development and business operations. For seasoned professionals, our employment opportunities span across various disciplines, inviting you to bring your valuable skills to our team.

Benefits and Culture

Gilead Sciences Inc is not only a great place to work but also offers competitive benefits designed to support the health, well-being, and financial security of our employees and their families. From health insurance to retirement plans and wellness programs, we ensure our team members are taken care of.

Networking and Professional Development

We emphasize the importance of networking and professional development within the company. Regular workshops, seminars, and training sessions are held to enhance your skills and knowledge. Additionally, Gilead’s strong emphasis on internal networking allows for cross-departmental collaboration and innovation.

Join Our Hiring Events

Stay connected with Gilead by joining our hiring events and exploring open positions that match your skills and interests. We are always on the lookout for dedicated, creative, and driven team players. Prepare your resume, ace the interview, and take the first step towards a fulfilling career at Gilead Sciences Inc.

Explore Jobs at Gilead Sciences Inc

Discover the exciting career opportunities waiting for you at Gilead Sciences Inc. Visit our careers page to search for open positions, read about our company culture, and learn how you can make a difference in the global healthcare landscape.

Stay Up to Date

Keep informed with the latest company news, career tips, and industry insights—all from the people who work at Gilead Sciences Inc. Subscribe to our job alert emails and personalize your experience to receive updates that align with your career preferences. Join Gilead Sciences Inc today and be part of a team that values innovation, leadership, and a commitment to diversity and employee growth.
Learn more about Gilead Sciences Inc
Size
14,400 employees
Market Cap
$107.2 billion
Industry
Pharmaceuticals & Biotech
Net Income
$123 million
Founded
1987
5 Year Trend
-2.1%
Revenue
$24.6 billion
NASDAQ
GILD
* Ladders Estimates

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