Gilead Sciences Inc

Sr Manager, Quality Assurance

Gilead Sciences Inc • $143K — $185K *
La Verne, CA 91750In-Person
Pharmaceuticals & Biotech
8 - 10 years of experience
Today
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Job Overview by Ladders

Qualifications

  • 8+ years of experience in a GMP environment and a BS or BA, or 6+ years with an MS.
  • In-depth knowledge of GMPs and/or GLPs.
  • Strong understanding of QA principles and industry standards.
  • Excellent verbal, written, and interpersonal communication skills.
  • Familiarity with international quality systems regulations.

Responsibilities

  • Ensure compliance with quality objectives and regulatory requirements.
  • Manage QA personnel and prioritize daily tasks.
  • Write and implement changes to controlled documents as needed.
  • Maintain high-quality product standards and compliance with GMPs and GLPs.
  • Review manufacturing and quality control data for products.
  • Oversee final product release processes.
  • Coordinate investigations and CAPA recommendations for manufactured products.
  • Interface with contract manufacturers on complex product issues.

Benefits

  • Discretionary annual bonus eligibility.
  • Discretionary stock-based long-term incentives.
  • Paid time off.
  • Company-sponsored medical, dental, vision, and life insurance plans.
Full Job Description
Job Description

The Senior Manager, Quality Assurance will be supporting the expanding site manufacturing and technology transfers into the medical device combination products modalities in La Verne, CA in alignment with PDM goals, have identified the need for experience and subject matter expertise within quality to support the medical device and combination product manufacturing.

Specific Job Responsibilities:
  • Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements.
  • Manages QA personnel, including organizing and prioritizing daily tasks, performing training, and writing performance reviews.
  • Writes and/or implements changes to controlled documents (e.g., SOPs, specifications, methods, etc.) as needed to ensure defined quality objectives are met.
  • Implements and maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).
  • Reviews manufacturing, environmental monitoring and quality control data for in-process and finished products.
  • Responsible for final release of manufactured products.
  • Works extensively with operating entities to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis, to enforce requirements and meet specifications.
  • May participate in the writing of annual product reviews and the development of training programs regarding all aspects of producing quality products.
  • Serves as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products. May lead compliance audits as required.
  • Interfaces with contract manufacturers to address and resolve more complex product/process performance issues.
  • Works with Research and Development during new product start-ups, and establishes key checkpoints for new products and processes.
  • May interface with regulatory agencies as required.


Basic Qualifications:
  • 8+ years of experience in a GMP environment related field and a BS or BA.
  • 6+ years of relevant experience and a MS.


Preferred Qualifications:
  • Demonstrates in-depth knowledge of GMPs and/or GLPs.
  • Demonstrates in-depth knowledge of QA principles, concepts, industry practices, and standards.
  • Demonstrates excellent verbal, written, and interpersonal communication skills.
  • Demonstrates keen understanding of international quality systems regulations to adopt best in class systems/processes, and drive continuous improvement initiatives.
  • Demonstrates knowledge of Information Systems Technology, understanding of Computer System Validation (CSV) including current electronic records and signature requirements.
  • Knowledge of Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, performance measures and quality improvement statistical is preferred.
  • Knowledge of Risk Management tools (e.g., Hazard Analysis and Critical Control Points (HACCP) and / or Failure Mode Effects Analysis (FMEA)) is preferred.
  • Certification by ASQ (Certified Quality Auditor, Certified Quality Engineer, and Certified Quality Manager) or other industry-recognized professional organizations is preferred.


The salary range for this position is: $143,225.00 - $185,350.00. 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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