Group Leader, Manufacturing Quality Assurance

Catalent•Kansas City, MO

3d•Onsite

About The Position

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.

Requirements

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.

Responsibilities

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.