Principal Specialist - Quality Assurance

Principal Specialist I - Quality Assurance (QA) Position Summary

• Work Schedule:
  
  Monday – Friday, core hours 8am-5pm
• 100% on-site (Madison, WI)

Catalent, Inc. is a leading global Contract Development and Manufacturing Organization (CDMO). Located in Madison, WI, this facility features advanced mammalian cell line engineering and biomanufacturing capabilities using single-use systems to support scalable production. This 263,000 sq. ft. Good Manufacturing Practice (GMP) facility offers integrated formulation and analytical services to address complex development challenges in Biologics.

The Principal Specialist I in QA will support the QA Systems group which has ownership over the quality systems, including deviations and Corrective and Preventive Actions (CAPAs), change controls, document control, Standard Operating Procedure (SOP) revisions, and training. You will be a key member of a multi‑site mission to deliver unparalleled service to our clients and quality drug products to the patients.

• Responsible for managing individual quality systems (QMS) such as Investigation, CAPA Management and Change Control Systems.
• Responsible for managing complex high‑level deviations and change controls, supporting Out‑of‑Specification (OOS) investigations, and collaborating with internal Catalent stakeholders to support effective execution of the quality systems.
• Maintains and enhances effectiveness of the Quality System, including developing and reporting metrics, identification, and implementation of improvement opportunities for established Quality Systems, processes, procedures, and training to support Deviation, OOS, CAPA, and Change Control processes.
• Develops and provides training to support consistent and effective execution of the Change Control, Investigation, and CAPA Management Systems.
• Provides notification to external clients on Change Controls, Deviations, or Investigations, as required. Files and maintains controlled documents.
• Drives alignment and improvement initiatives, leading cross‑functional teams, to address process improvement, system improvement, and new regulations/expectations. Provides technical assistance and training for personnel.
• Other duties as assigned.

• STEM‑related degree required:
  Associate’s minimum with 25 years experience;
  Bachelor’s with 22 years or Master’s with 17 years or PhD with 14 years of relevant experience.
• Deep technical understanding of Microsoft Office and a QMS such as Track Wise or Compliance Wire.
• Strong understanding of regulatory guidelines (cGMP, ICH, FDA, EMA, etc.) and ability to complete investigations, deviations, and change controls independently.
• Advanced understanding of pharmaceutical laboratory and/or production operations. Biologics knowledge in a CDMO environment highly preferred.
• Hands‑on experience with Risk Assessment (Hazard Analysis, Fault Tree Analysis, FMEA, etc.).
• 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.
• Physical requirements:
  
  Ability to see, hear, read, write clear English. Frequent sitting, standing, walking, reading, use of computer monitor, reaching, talking, writing. Occasional stooping, kneeling, crouching, bending, carrying, grasping. Frequent lifting up to 10 pounds and occasionally up to 50 pounds. Must comply with EHS responsibilities.

• Defined career path and annual performance review and feedback process.
• Diverse, inclusive culture.
• 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 401(k) match.
• Medical, dental and vision benefits.
• Tuition Reimbursement.

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 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, please send your request to Disabili with the job number, title and location. This option is reserved for individuals who require accommodation due to a disability.