Lead Biomanufacturing Compliance Investigator

Catalent Pharma Solutions; Madison (WI); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Defined career path

Diverse, inclusive culture

Career growth opportunities

Competitive PTO and holidays

Medical, dental, vision benefits

Job summary

Catalent in Madison, WI is seeking a Lead - Biomanufacturing Compliance - Investigator, Deviations to manage deviation records and cGMP documents onsite. You will collaborate with manufacturing and quality systems, support audits, and drive inspection readiness and continuous improvement initiatives.

The role emphasizes SOP development, CAPA activities, and regulatory compliance within a GMP manufacturing environment.

Qualifications

• Experience writing deviations and with Root Cause Analysis and CAPA implementation.
• Ability to apply cGMP principles to ensure compliant, high-quality execution.
• Experience with SOPs and related documentation.

Responsibilities

• Author and revise deviation records and cGMP documents.
• Lead inspections readiness activities and teams.
• Provide support to audits and CAPA status.
• Write and revise Standard Operating Procedures.
• Collaborate with manufacturing and quality systems groups.

Skills

Deviation writing

Root Cause Analysis

Corrective Actions

Preventive Actions

SOP writing

Audit readiness

Quality systems knowledge

Education

High School Diploma or GED

Associate degree in STEM

Bachelor’s degree in STEM

MS/PhD in technical discipline

Tools

TrackWise

ComplianceWire

JD Edwards

Unicorn

Microsoft Office

Job description

Catalent in Madison, WI is seeking a Lead - Biomanufacturing Compliance - Investigator, Deviations to manage deviation records and cGMP documents onsite. You will collaborate with manufacturing and quality systems, support audits, and drive inspection readiness and continuous improvement initiatives.

The role emphasizes SOP development, CAPA activities, and regulatory compliance within a GMP manufacturing environment.