Senior IPQA & Validation Lead | GMP Compliance

Glenmarkpharma; Monroe (NC); On-site; USD 140,000 - 190,000; Full time

Job summary

Glenmarkpharma in Monroe, NC seeks a Manager of IPQA/QA-Validation to lead the IPQA team and drive validation/qualification programs for instruments, equipment and facilities. This role ensures GMP compliance, supports facility start-up activities, technology transfers and ongoing validation across manufacturing, maintenance and warehouse functions.

The ideal candidate has 6–8 years in QA/Design Assurance within pharma/biotech, with strong knowledge of CGMP, regulatory guidelines and CSV/QMS.

Qualifications

• 6-8 years of experience in Quality Assurance or Design Assurance in the Pharmaceutical/Biotech/medical device industry
• Experience with IPQA/QA-Validation activities and GMP/GLP systems
• Certified Lean Six Sigma Green Belt or Black Belt and/or CQE preferred

Responsibilities

• Lead IPQA/QA-Validation activities across manufacturing, QA and validation programs
• Oversee instrument, equipment and facility qualification (IQ/OQ/PQ) and validation lifecycle documentation
• Support regulatory inspections by FDA and foreign agencies
• Provide training and mentorship to staff; ensure SOPs are up to date and compliant
• Maintain visual inspection qualification program including AQL for products

Skills

CGMP

Validation & Qualification

Regulatory guidelines

US Pharmacopoeias

Internal auditing

Regulatory inspections

QMS & CSV

GMP/GLP/QDP

ICH Q8/Q10

Documentation

Education

Bachelor’s degree in Pharmaceutical Science or Engineering

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

Glenmarkpharma in Monroe, NC seeks a Manager of IPQA/QA-Validation to lead the IPQA team and drive validation/qualification programs for instruments, equipment and facilities. This role ensures GMP compliance, supports facility start-up activities, technology transfers and ongoing validation across manufacturing, maintenance and warehouse functions.

The ideal candidate has 6–8 years in QA/Design Assurance within pharma/biotech, with strong knowledge of CGMP, regulatory guidelines and CSV/QMS.