Supervisor, Quality Assurance

Posted Yesterday
Be an Early Applicant
Madison, WI, USA
In-Office
Mid level
Biotech • Pharmaceutical
The Role
Lead and develop a QA team supporting CGMP pharmaceutical manufacturing. Oversee daily QA operations, document control, deviations/CAPAs, training, materials quality, KPI tracking, audits/inspection readiness, and continuous improvement to ensure FDA compliance and product quality.
Summary Generated by Built In

Supervisor, Quality Assurance

Position Summary:

  • Work Schedule: 2nd shift Monday-Friday afternoons
  • 100% on-site

Catalent Madison is a pharmaceutical manufacturing site specializing in the development and production of high-quality drug products, with a strong focus on biologics and sterile injectables. The site supports global clients by delivering compliant, reliable, and scalable manufacturing solutions.

The Quality Assurance Supervisor at Catalent Madison is responsible for ensuring full compliance with FDA regulations and internal quality systems to support the delivery of high-quality drug products. This position leads team performance, oversees daily QA operations, and drives continuous improvement across quality systems, including deviations, CAPAs, document control, materials management, and training. The Quality Assurance Supervisor partners closely with cross-functional stakeholders to maintain efficient processes, support manufacturing operations, and ensure audit and inspection readiness. Additionally, it is accountable for developing talent, managing performance, and reinforcing a compliant and high-performing quality culture.

The Role:

  • Lead, coach, and develop team members to strengthen performance and support career growth
  • Set clear goals, monitor progress, and address performance issues with timely feedback
  • Oversee daily QA operations to ensure quality standards and project timelines are met
  • Partner with stakeholders to maintain efficient processes and ensure compliant quality practices
  • Support and execute Quality Management Systems within CGMP manufacturing and QC environments
  • Track KPIs, report performance, and implement action plans to close gaps and meet objectives
  • Author, review, and approve procedures, protocols, deviations, and investigation records
  • Drive continuous improvement initiatives across systems, processes, training, and regulatory readiness
  • Manage document control processes, ensuring integrity, compliance, and system enhancements
  • Oversee materials quality and training programs, including compliance, onboarding, system management, and cross-functional support
  • Other duties as assigned

The Candidate:

  • Doctorate Degree in STEM discipline with minimum of 2 years related experience
  • Master's, Bachelor’s or Associate’s Degree in STEM discipline with minimum of 4 years related experience
  • Leadership experience 0-2 years
  • Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience

Why you should join Catalent:

  • Potential for career growth on an expanding team
  • Abundance of cross-functional exposure to other areas within the organization
  • Opportunity to work globally
  • 152 hours of paid time off annually + 8 paid holidays
  • Day one benefits! Medical, dental, vision and 401K benefits effective on your first day

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 [email protected]. 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 [email protected] for us to investigate with local authorities.

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

Skills Required

  • Doctorate in STEM with minimum 2 years related experience, or Master's/Bachelor's/Associate in STEM with minimum 4 years related experience
  • Leadership experience (0-2 years) and ability to lead, coach, and develop team members
  • Experience with Quality Management Systems, CGMP manufacturing, and FDA regulations
  • Experience managing deviations, CAPAs, document control, investigations, and KPI tracking
  • Ability to work 2nd shift, Monday-Friday (afternoons); 100% on-site
  • Experience with continuous improvement and audit/inspection readiness in pharma environments
  • Prior participation in Catalent leadership programs may substitute for external leadership experience

Catalent, Inc. Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Catalent, Inc. and has not been reviewed or approved by Catalent, Inc..

  • Leave & Time Off Breadth Paid time off is commonly described as roughly 152 hours per year plus about eight paid holidays for U.S. roles. Eligibility and exact counts vary by location, but the allotment is positioned as competitive.
  • Retirement Support A 401(k) with a company match (often described as dollar‑for‑dollar up to 6%) is part of the package. The match level is commonly referenced as a meaningful component of total rewards.
  • Inclusive Benefits Coverage Medical, dental, vision, life/disability, HSA/FSA, EAP, tuition reimbursement, adoption assistance, commuter and dependent‑care benefits, and wellness programs are offered. Some roles indicate benefits eligibility begins on the first day for direct hires.

Catalent, Inc. Insights

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The Company
HQ: Somerset, NJ
13,715 Employees
Year Founded: 2007

What We Do

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. For more information, visit www.catalent.com.

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