IPQA & QA Validation Lead — GMP Compliance

Glenmark Pharmaceuticals; Monroe (NC); On-site; USD 110,000 - 170,000; Full time

Job summary

Glenmark Pharmaceuticals seeks a Manager of IPQA/QA-Validation to lead the IPQA team and own validation/qualification programs across instruments, equipment, and facilities. You will provide QA oversight for shop floor activities, sampling, and hold notifications, ensuring alignment with regulatory standards.

The role includes management of validation lifecycle documentation, change controls, and collaboration with manufacturing, maintenance, and warehouse functions, with emphasis on continued

Qualifications

• Bachelor’s degree in Pharmaceutical Science or Engineering is required.
• 6–8 years of experience in Quality Assurance or Design Assurance in Pharma/Biotech/related industries.
• Advanced degrees may reduce required experience.

Responsibilities

• Lead IPQA/QA-Validation activities and oversee validation programs.
• Manage the validation system from a QA perspective.
• Oversee sampling for in-process, finished product, stability, and retention samples.

Skills

CGMP

Validations & Qualifications

Regulatory guidelines

US Pharmacopoeias

Internal auditing

Regulatory inspections

QMS & CSV

Change control

GMP/GLP/QDP

Statistics (assorted methods)

Education

Bachelor’s degree in Pharmaceutical Science or Engineering

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

Glenmark Pharmaceuticals seeks a Manager of IPQA/QA-Validation to lead the IPQA team and own validation/qualification programs across instruments, equipment, and facilities. You will provide QA oversight for shop floor activities, sampling, and hold notifications, ensuring alignment with regulatory standards.

The role includes management of validation lifecycle documentation, change controls, and collaboration with manufacturing, maintenance, and warehouse functions, with emphasis on continued