Supervisor - Quality Control, Data Review

Full-timeOncologyBiologics
$69K - $130K/yr(estimated)
Estimated based on industry data, role level, and location. Actual compensation may vary. Required by CO/NYC/CA salary transparency laws.
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Description

Supervisor - Quality Control, Data Review

Position Summary:

  • Work Schedule: M-F 8am-5pm
  • 100% on-site

Catalent’s Core Biologics segment is a rapidly growing business within Catalent Pharma Solutions, dedicated to delivering innovative technologies and solutions that help bring more and better biologic treatments to patients. Our capabilities include the proprietary GPEx Lightning cell line engineering platform, a state-of-the-art biomanufacturing facility in Madison, WI, and a drug product development and manufacturing site in Limoges, France. By leveraging our differentiated technology portfolio, world-class manufacturing expertise, and integrated services across the Catalent network, Core Biologics is positioned for significant strategic growth.

Joining Catalent means becoming part of a talented, driven, and collaborative team. We are making substantial investments in people and capabilities, reflected in recent and planned expansions at our sites. This is a unique opportunity to contribute to a fast-growing business backed by a leading private equity firm, with strong potential for career development as we continue to scale. Our work has a direct impact on patients—delivering first-in-human therapies with speed and  quality, supporting both clinical and commercial manufacturing to reach global populations. At Catalent Madison, our teams are advancing treatments for cancer, autoimmune and infectious diseases, fibrotic and blood disorders, HIV, diabetes, cardiovascular and pulmonary conditions, and neurological diseases such as Alzheimer’s.

Catalent Pharma Solutions in Madison, WI is hiring a Supervisor - Quality Control, Data Review. The Quality Control (QC) team is responsible for testing products, raw materials, and the manufacturing environment to ensure the safety, quality, identity, purity, and potency produced by the Catalent Madison Biologics facility.

The Role:

  • Track and report performance indicators.
  • Implement action plans to address gaps and achieve department objectives.
  • Author and revise procedures and approve protocols associated with the assigned functional area.
  • Write, review, and approve deviation and investigation records (as needed)
  • Ensure employee training is executed according to defined training plans and maintains current training plans.
  • Drive continuous improvement through leading cross function teams to address process improvement, system improvement, new regulations/expectations, new business needs, training improvements, and KPI performance improvements.
  • Maintain safe and healthy work environment by establishing and enforcing organization standards and adhering to legal regulations.
  • Review and approve QC data and reports.
  • Collaborate with other departments to ensure on-time-delivery of results to support lot release, stability, etc.
  • Conduct performance reviews and engage in employee hiring process.
  • Provide technical assistance for personnel.
  • Lead team members to improve and reinforce performance of others
  • Take responsibility for direct reports’ performance by setting clear goals and expectations, tracking progress against the goals, ensuring constructive feedback, and addressing performance-related concerns and issues promptly
  • Work with, coach, and support direct reports in developing knowledge, skills, and abilities in the interest of performance improvement and employee’s career development
  • Other duties as assigned.

The Candidate:

  • Doctorate Degree in STEM discipline with minimum of 2 years related experience, OR
  • Master's Degree in STEM discipline with minimum of 4 years related experience, OR
  • Bachelor's Degree in STEM discipline with minimum of 5 years related experience, AND
  • Leadership experience 0 - 2 years.

Why you should join Catalent:

  • Defined career path and annual performance review and feedback process 
  • Diverse, inclusive culture 
  • Positive working environment focusing on continually improving processes to remain innovative
  • Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives 
  • 152 hours of PTO + 8 paid holidays
  • Generous 401K match 
  • Medical, dental and vision benefits effective day one of employment 
  • Tuition Reimbursement - Let us help you finish your degree or start a new degree!

Catalent offers rewarding opportunities to further your career!  Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. 

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

    

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE.

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OncologyMadison, WI
C

Catalent

CDMO

LocationNJ - Somerset
Employees10001-50000
Open Jobs301

Pipeline

MEDI1341Phase 1
Ademetionine IV+tabletPhase 3
MELT-300 sublingual tabletPhase 3
CreonPhase 4