Gilead Sciences Inc

Supervisor, Quality Control

Gilead Sciences Inc • $107K — $138K *
Frederick, MD 21702In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree in Microbiology, Biology, Biochemistry, or Life Sciences with 5+ years in QC Microbiology.
  • Previous supervisory or leadership experience in laboratory settings.
  • Expertise in Environmental Monitoring, Utilities Monitoring, and aseptic processing.
  • Experience handling OOS results and CAPA investigations.
  • Strong knowledge of FDA, EMA, and cGMP regulations.

Responsibilities

  • Oversee daily QC Microbiology Laboratory operations and testing activities.
  • Ensure timely execution of microbiological testing for product release.
  • Review and approve test data and laboratory records regularly.
  • Lead and manage Environmental and Utilities Monitoring programs.
  • Monitor environmental data trends and report findings to management.
  • Supervise QC Microbiology staff and conduct performance evaluations.
  • Serve as Subject Matter Expert for investigations involving EM and UM excursions.

Benefits

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

Key Responsibilities:

Laboratory Operations & Testing
  • Oversee daily operations and testing activities within the QC Microbiology Laboratory.
  • Ensure timely and compliant execution of microbiological testing to support manufacturing and product release.
  • Perform routine review and approval of test data, laboratory records, and associated documentation.
  • Support the generation and review of Certificates of Analysis (CoAs) for product release.
Environmental Monitoring & Compliance
  • Lead and sustain the site's Environmental Monitoring (EM) and Utilities Monitoring (UM) programs.
  • Monitor environmental and utility data, identify trends, and communicate findings to management.
  • Assemble reports and provide routine updates on environmental monitoring performance and compliance.
  • Implement corrective and preventive actions when adverse trends or excursions are identified.
  • Support optimization of the aseptic gowning qualification and training program.
Leadership & Team Development
  • Supervise QC Microbiology staff and laboratory activities.
  • Conduct performance evaluations, coaching, and regular employee development discussions.
  • Maintain training programs and ensure ongoing qualification of QC Microbiology personnel.
  • Foster a culture of quality, compliance, accountability, and continuous improvement.
Investigations & Problem Solving
  • Serve as Subject Matter Expert (SME) for EM and UM investigations.
  • Lead or support investigations involving:
    • Environmental monitoring excursions
    • Utilities monitoring excursions
    • Out-of-Specification (OOS) results
    • Deviations associated with microbiological procedures
  • Identify root causes and implement effective corrective and preventive actions (CAPAs).
Quality Systems & Documentation
  • Develop, review, revise, and approve:
    • Standard Operating Procedures (SOPs)
    • Validation and qualification protocols
    • Validation and qualification reports
    • Controlled quality documentation
  • Monitor GMP systems to ensure continued compliance with internal procedures and regulatory requirements.
  • Review proposed changes to methods, procedures, systems, and regulatory submissions as needed.
Audits & Regulatory Support
  • Support internal, customer, and regulatory inspections and audits.
  • Ensure laboratory activities remain compliant with cGMP requirements and company quality standards.
  • Represent the QC Microbiology function during cross-functional, site, and global meetings.
Continuous Improvement & Communication
  • Collect and analyze departmental metrics to drive continuous improvement initiatives.
  • Provide updates and key performance indicators during daily, weekly, and management meetings.
  • Collaborate with Manufacturing, Quality Assurance, Validation, Facilities, and other functional groups to support site objectives.
  • Perform additional responsibilities and special projects as assigned.

Preferred Qualifications:
  • Bachelor's degree in Microbiology, Biology, Biochemistry, Life Sciences, or related scientific discipline with at least 5 years of experience in QC Microbiology within a pharmaceutical, biotechnology, cell therapy, or other GMP-regulated environment.
  • Previous supervisory or leadership experience managing laboratory personnel.
  • Strong experience with:
    • Environmental Monitoring (EM)
    • Utilities Monitoring (UM)
    • Aseptic processing and gowning qualification
    • OOS, deviation, and CAPA investigations
    • Product release support
  • Working knowledge of FDA, EMA, and cGMP regulations.

Knowledge, Skills & Abilities:
  • Strong understanding of microbiology laboratory operations within a cGMP environment.
  • Expertise in environmental monitoring programs, data trending, and contamination control principles.
  • Proven ability to lead investigations and perform root cause analysis.
  • Excellent leadership, coaching, and employee development skills.
  • Strong technical writing and documentation review capabilities.
  • Effective verbal and written communication skills with the ability to interact across all levels of the organization.
  • Ability to manage multiple priorities in a fast-paced manufacturing environment.
  • Demonstrated commitment to quality, compliance, and continuous improvement.


The salary range for this position is: $107,185.00 - $138,710.00. Kite 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 Current Kite Pharma Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.

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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