Lead Biomanufacturing Compliance Investigator

Catalent; Madison (WI); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical, dental, and vision benefits

Tuition Reimbursement

8 paid holidays

Job summary

Catalent’s Madison, Wisconsin site seeks a Lead - Biomanufacturing Compliance - Investigator, Deviations. You will author and revise deviation records and related cGMP documents, collaborating with Manufacturing and Quality to ensure timely, compliant completion. You will support audits and drive corrective actions while promoting a strong compliance culture.

Shift: Mon–Friday, core hours 9am–4pm. Location: Madison, WI. 100% onsite.

Qualifications

• 7+ years of related experience with a STEM degree
• Experience in writing deviations and with Root Cause Analysis and CAPAs
• Proficiency with quality systems and cGMP principles
• Experience supporting internal and client audits, and SOP writing

Responsibilities

• Author and revise deviation records, CAPAs, and related cGMP documents
• Collaborate with manufacturing and quality systems to ensure compliance
• Lead inspections readiness activities and teams
• Track and report status of open investigations
• Support audits and client inquiries regarding deviations and corrective actions
• Develop and revise Standard Operating Procedures to close gaps
• Participate in biomanufacturing compliance meetings

Skills

Deviation writing

Root cause analysis

cGMP knowledge

Audits support

Documentation writing

Education

Bachelor's degree in STEM

MS/PhD in technical discipline

Tools

TrackWise

ComplianceWire

JD Edwards

Unicorn

Job description

Catalent’s Madison, Wisconsin site seeks a Lead - Biomanufacturing Compliance - Investigator, Deviations. You will author and revise deviation records and related cGMP documents, collaborating with Manufacturing and Quality to ensure timely, compliant completion. You will support audits and drive corrective actions while promoting a strong compliance culture.

Shift: Mon–Friday, core hours 9am–4pm. Location: Madison, WI. 100% onsite.