Associate Director, Quality Assurance (Drug Substance/Drug Product)

📋 Description

• Oversee GxP quality activities across drug substance/product.
• Ensure compliance with GMP, GCP, GLP, GVP globally.
• Primary QA contact for CMOs, labs, suppliers.
• Audit and review vendor docs, batch records, release docs.
• Lead product release support for substance, product, packaging.
• Monitor quality metrics and regulatory inspections support.

🎯 Requirements

• Bachelor in a scientific field; advanced degree a plus.
• 6–8 years pharma, with 6+ in QA or related field.
• Keen understanding of GxP standards and regulatory requirements.
• Experience with small‑molecule API and non‑sterile dosage forms.
• Experience with CMOs and external vendors; GMP audits preferred.
• Strong communication, analytical, and cross‑functional collaboration.

🎁 Benefits

• Competitive base salary; annual bonus.
• Long‑term incentives; comprehensive health, dental, vision.
• Life and disability insurance; retirement plan options.
• Fully remote position within the United States.
• Impactful work across late‑stage and commercial programs.
• Collaborative environment with cross‑functional exposure.