QA Operations Leader, GMP Compliance & Process

Catalent Pharma Solutions; United States; On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

PTO + holidays

401K match

Medical, dental and vision benefits

Tuition reimbursement

Job summary

Catalent Pharma Solutions in Madison, WI is seeking a Manager - Quality Assurance (QA), Operations to lead QA operations, ensure CGMP and QMS compliance, support technology transfers, and manage product disposition and CAPA responses.

The role requires a STEM bachelor’s and 9+ years GMP QA experience with 4+ years in leadership, or a Master’s with 7+ years or a PhD with 4+ years. Lead a high-performing team and drive continuous improvement while acting as the quality interface with clients.

Qualifications

• Bachelor’s degree in STEM plus a minimum of 9 years of relevant GMP experience in QA Operations with at least 4 years in a leadership capacity.
• Master’s degree with 7+ years OR a PhD with 4+ years of relevant experience.
• Ability to ensure data integrity and full compliance with SOPs, cGMP, ICH, FDA, EMA requirements across multiple disciplines.

Responsibilities

• Lead, coach, and develop QA Operations team with clear goals and performance feedback.
• Ensure CGMP and QMS compliance across manufacturing and quality control operations.
• Oversee change control, audit readiness, and CAPA development/implementation.
• Serve as primary Quality interface with clients and maintain strong quality relationships.
• Ensure adequate Quality resources to support GMP operations, technology transfers, and batch execution.
• Champion continuous improvement initiatives and lead cross‑functional quality trainings.
• Other duties as assigned

Skills

Leadership

People management

Quality systems

Regulatory knowledge

Communication skills

Education

Bachelor's degree in STEM

Master’s degree

PhD

Job description

Catalent Pharma Solutions in Madison, WI is seeking a Manager - Quality Assurance (QA), Operations to lead QA operations, ensure CGMP and QMS compliance, support technology transfers, and manage product disposition and CAPA responses.

The role requires a STEM bachelor’s and 9+ years GMP QA experience with 4+ years in leadership, or a Master’s with 7+ years or a PhD with 4+ years. Lead a high-performing team and drive continuous improvement while acting as the quality interface with clients.