Kitepharma
Supervisor, Quality Control
United States - Maryland - Frederick
Sponsorship not specified$107k-$139kDetected 6 days ago
GMPFDA RegulatoryLeadershipCommunicationProblem SolvingMentoringWriting
About the role
- We're here for one reason and one reason only - to cure cancer.
- We've made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm.
- Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.
Responsibilities
- 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.
- Lead and sustain the site's Environmental Monitoring (EM) and Utilities Monitoring (UM) programs.
- Implement corrective and preventive actions when adverse trends or excursions are identified.
- Support optimization of the aseptic gowning qualification and training program.
- Maintain training programs and ensure ongoing qualification of QC Microbiology personnel.
- Lead or support investigations involving:
- Identify root causes and implement effective corrective and preventive actions (CAPAs).
- Develop, review, revise, and approve:
Nice to have
- 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
- Working knowledge of FDA, EMA, and cGMP regulations.
- Knowledge, Skills & Abilities:
Skills
- Strong understanding of microbiology laboratory operations within a cGMP environment.
- Expertise in environmental monitoring programs, data trending, and contamination control principles.
- 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.
- Demonstrated commitment to quality, compliance, and continuous improvement.
Compensation
- $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*.
- Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
Company info
- Every moment is dedicated to developing treatments and every action moves us one step closer to our goal.
- But we're not finished yet.
- We believe every employee deserves a great leader.
- People Leaders are the cornerstone to the employee experience at Gilead and Kite.
- As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations.
- Join Kite and help create more tomorrows.
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This listing is sourced directly from Kitepharma's careers page and normalized into a canonical job model.