QA Operations Manager - GMP & Compliance

Regulatory Jobs; Madison (WI); On-site; USD 130,000 - 170,000; Full time

Benefits offered by this job

PTO + holidays

401K match

Medical, dental & vision

Tuition reimbursement

Job summary

Catalent, a global CDMO, is seeking a Manager - QA Operations to lead manufacturing QA activities in Madison, WI. The role oversees CGMP compliance, process transfers, batch disposition, and CAPA programs, while ensuring data integrity across QA and manufacturing functions.

The ideal candidate brings a STEM degree with extensive GMP QA leadership experience, strong regulatory knowledge, and excellent communication with customers and cross-functional teams.

Qualifications

• Bachelor’s degree in STEM required with 9+ years of GMP QA Operations experience
• Leadership experience: 4+ years in a leadership capacity or equivalent
• Ability to ensure data integrity and comply with SOPs, CGMP, ICH, FDA, and EMA requirements

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
• Act as primary Quality interface with clients and manage communication and relationships
• Oversee change control, audits, CAPAs, and audit responses
• Recruit and develop a high-performing Quality team aligned with site objectives
• Drive continuous improvement initiatives and cross-functional training

Skills

Leadership

QA Operations

GMP

Process Improvement

Regulatory Knowledge

Data Interpretation

Education

Bachelor's degree in STEM

Master's degree

PhD

Tools

QMS systems

CGMP knowledge

Job description

Catalent, a global CDMO, is seeking a Manager - QA Operations to lead manufacturing QA activities in Madison, WI. The role oversees CGMP compliance, process transfers, batch disposition, and CAPA programs, while ensuring data integrity across QA and manufacturing functions.

The ideal candidate brings a STEM degree with extensive GMP QA leadership experience, strong regulatory knowledge, and excellent communication with customers and cross-functional teams.