QA Manager, Pharma GMP & Compliance

Granules Pharmaceuticals Inc.; Chantilly, Northern (VA, KY); Hybrid; USD 110,000 - 150,000; Full time

Job summary

Granules Pharmaceuticals Inc. in Chantilly, VA is hiring a QA Manager responsible for ensuring GMP/FDA compliance and documentation across quality system functions. You will lead QA staff, manage CAPA, audits, and regulatory submissions, while driving continuous improvement and cross-functional collaboration.

The role requires extensive experience in pharmaceutical QA, cGMP, and FDA regulations, with a focus on training, validation support, and staff development.

Qualifications

• Experience ensuring compliance with FDA regulations and cGMP expectations.
• Strong documentation practices across QA activities and audits.
• Ability to lead cross-functional teams and manage priorities.

Responsibilities

• Oversee QA operations to ensure GMP, FDA and SOP requirements are met.
• Lead QA staff and coordinate training, CAPA and audit readiness.
• Support regulatory filings and review validation documentation.
• Manage investigations, change control, and batch-release processes.
• Drive continuous improvement through quality systems and tools.
• Collaborate with leadership to develop succession and high-performance culture.
• Ensure timely product disposition and adherence to training plans.

Skills

FDA regulations

cGMP compliance

Documentation

Data analysis

Cross-functional teams

Verbal & written communication

Prioritization

MS Office

Adobe

Problem solving

Education

Bachelor's degree in life sciences

Master’s degree in life sciences or related field

Job description

Granules Pharmaceuticals Inc. in Chantilly, VA is hiring a QA Manager responsible for ensuring GMP/FDA compliance and documentation across quality system functions. You will lead QA staff, manage CAPA, audits, and regulatory submissions, while driving continuous improvement and cross-functional collaboration.

The role requires extensive experience in pharmaceutical QA, cGMP, and FDA regulations, with a focus on training, validation support, and staff development.