Job Description

Group Leader, Commercial Quality Assurance

• Shift: Monday-Friday 8am-4:30pm
• 100% on-site

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.

The Group Leader, Commercial Quality Assurance provides leadership and day‑to‑day oversight for QA activities that support commercial manufacturing operations. In this role, you will guide a team responsible for document review, batch record evaluation, product release, and ensuring all manufacturing and testing processes comply with FDA regulations, GxPs, and internal SOPs.

You will play a key role in reviewing investigations, deviations, and CAPAs; supporting root‑cause analysis; and helping drive continuous improvement across the QA function. This position also partners closely with customers and internal teams, offering quality guidance, supporting project outcomes, and helping ensure products meet established compliance and quality standards.

The role:

• Provides leadership and guidance to the Commercial quality team.
• Responsible for the oversight of Quality Support functions with manufacturing of products.
• EDMS qualified to review and approve documents.
• Responsible for generating and presenting metrics.
• Performs final batch record review, product release, and disposition.
• Reviews and tracks investigations/deviations, corrective actions & effectiveness checks. Participates in Rapid Response Meetings to evaluate Root Cause Analysis as appropriate.
• Ensures that products are manufactured, tested, and released according to applicable FDA guidelines, regulations and GXPs and internal SOP’s.
• Participates in the development and maintenance of QA programs, procedures, and controls to ensure that products conform to established standards and agency guidelines.

The candidate:

• BS/ BA in related field and 2+ years of scientific or quality assurance experience.
• Associate degree and 5+ years of related scientific or quality assurance (QA) experience
• Demonstrated ability to provide instruction, guidance, and direction to others (team leadership capability).
• Experience solving both routine and non‑routine quality issues using established procedures.
• Ability to identify, assess, and escalate aberrant data or potential quality/compliance concerns.
• Strong communication skills and the ability to lead difficult customer discussions and drive resolution.

Why you should join Catalent:

• Competitive medical benefits and 401K
• 152 hours PTO + 8 Paid Holidays
• Dynamic, fast-paced work environment
• Opportunity to work on Continuous Improvement Processes

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