FDA Compliance Manager; MUSTHAVE IQ, PQ and OQ-Validation

Job Description

Our client is a leading provider of compliance, validation, and quality assurance services supporting pharmaceutical, medical device, biotech, and regulated manufacturing clients. We help organizations meet and maintain Good Manufacturing Practice (GMP) standards to ensure safe, consistent, high-quality product output.

Position Summary

Our client is seeking an experienced Project Manager – Compliance (cGMP/Validation) to lead validation and compliance projects within regulated GMP environments. This role requires hands-on validation expertise, strong project management skills, and the ability to work directly with clients to ensure compliance with global regulatory requirements.

The ideal candidate has direct experience performing IQ, OQ, and PQ qualifications and has validated HVAC systems, refrigerators, walk-in coolers/freezers, and conducted temperature mapping studies.

Key Responsibilities

Validation & Technical Execution

• Perform and oversee IQ, OQ, and PQ validation activities.

• Conduct validation and qualification of HVAC systems, refrigerators, freezers, and walk-in environmental units.

• Lead temperature mapping studies using industry-standard tools and data loggers.

• Prepare validation protocols, risk assessments, deviation reports, and final reports.

• Ensure all validation work aligns with applicable GMP guidelines, including:

  • FDA 21 CFR Part 211 and Part 820

  • EU-GMP

  • WHO GMP

  • ICH Q7

  • IPEC Guide for Excipient Manufacturing

Project Management

• Lead validation and compliance projects from planning through execution and closeout.

• Develop project scopes, timelines, and resource plans to meet client requirements.

• Maintain strong client communication and serve as the primary point of contact.

• Track progress, identify risks, and ensure timely delivery of project milestones.

Compliance & Quality Systems

• Support internal and client GMP audits, identifying gaps and developing CAPA plans.

• Ensure compliance with applicable sections of 21 CFR Part 211 (e.g., Facilities, Equipment, Process Controls, Laboratory Controls, Records & Reports).

• Assist in developing and revising SOPs, validation templates, and controlled documentation.

• Train client personnel on validation practices and GMP expectations.

Required Qualifications

• Minimum 5 years of experience in GMP environments, validation, or quality assurance.

• Proven hands-on experience with IQ, OQ, PQ validation.

• Experience with HVAC systems, refrigerators, freezers, walk-in units, and temperature mapping.

• Strong understanding of GMP regulations and global compliance standards.

• Excellent technical writing and documentation skills.

• Ability to interpret equipment manuals, engineering drawings, and technical schematics.

• Strong analytical thinking, attention to detail, and problem-solving abilities.

Preferred Qualifications

• Experience in pharmaceutical, medical device, biotech, or excipient manufacturing.

• Previous experience conducting internal GMP audits.

• Bachelor's degree in Engineering, Life Sciences, or related discipline.

• Familiarity with data integrity requirements (ALCOA/ALCOA+).

Additional Requirements

• Ability to travel to client sites as needed.

• Ability to work independently and manage multiple projects simultaneously.

• Professional communication and presentation skills.

• High personal standards for quality, compliance, and ethical conduct.

Great Company culture

Great Company culture