JobMesh

Director, Quality Assurance (Compliance)

Granules India Limited · Chantilly, Virginia, US

Description **US Based Candidates Only** Granules Pharmaceuticals, Inc. , located in Chantilly, VA was the 10th fastest growing generic pharma company in Uni...

Job description

Description: **US Based Candidates Only** Granules Pharmaceuticals, Inc., located in Chantilly, VA was the 10th fastest growing generic pharma company in United States in 2024 based on sales growth! We manufacture dosage forms with specific release capabilities including pulsatile drug release in tablet and capsule dosage form, orally disintegrating modified release tablets (XR, MR, ER), modified release suspension and controlled substances capabilities in an abuse deterrent technology platform, all supported by our API business. Granules is one of the few pharmaceutical companies to be vertically integrated from API to packaging. As a Director, QA Compliance, you will be accountable for the leadership activities and to direct all facets of Quality Compliance including, but not limited to, managing Quality Systems (incidents resolution, CAPAs, change control, complaints resolution), host FDA inspections and respond to questions arising from the inspections, oversee remediation activities for site-wide compliance improvements, external and internal audits, training with effectiveness checks, Quality metrics, data trending and evaluation with recommendations for cGMP Compliance impro...