Director, Quality Assurance – Sterile Pharma Leadership

QuVa Pharma; Bloomsbury (NJ); On-site; USD 164,000 - 226,000; Full time

Benefits offered by this job

Comprehensive health benefits

401k with company match

PTO + paid holidays

Career advancement opportunities

Job summary

Quva Pharma in Bloomsbury, New Jersey is seeking a Director of Quality Assurance to lead QA and Quality Systems for sterile compounding operations, ensuring compliance with FDA 503B and cGMP. The role oversees QA/QS staff, directing release of batches and handling Deviations, CAPAs, and change controls with robust documentation.

This onsite leadership role requires strong technical writing, regulatory knowledge, and effective cross‑functional communication to maintain product quality and

Qualifications

• Bachelor's Degree in Life Science or related field.
• Minimum 10 years prior experience in Quality Assurance / cGMP / FDA regulated industry.
• Minimum 5 years of supervisory or management experience.
• Experience with aseptic techniques and appropriate gowning techniques supporting manufacturing of sterile injectable products.

Responsibilities

• Supervises QA & QS managers by providing learning and development where appropriate.
• Ability to make Quality decisions related to maintenance of aseptic conditions within clean rooms with focus on Sterility Assurance during manufacturing operations.
• Manages the on-time release of batches.
• Manages the on-time initiation and closure of Deviations / Investigations, CAPAs, Change Controls with thorough & standardized supporting documentation.
• Maintains site documents supporting commercial manufacturing & release of sterile injectable products.
• Escalates to VP of Quality critical issues jeopardizing manufacturing & release of a safe & effective product.

Skills

Supervisory experience

Quality Assurance

cGMP knowledge

Regulatory compliance

Communication skills

Education

Bachelor's Degree in Life Science or related field

Job description

Quva Pharma in Bloomsbury, New Jersey is seeking a Director of Quality Assurance to lead QA and Quality Systems for sterile compounding operations, ensuring compliance with FDA 503B and cGMP. The role oversees QA/QS staff, directing release of batches and handling Deviations, CAPAs, and change controls with robust documentation.

This onsite leadership role requires strong technical writing, regulatory knowledge, and effective cross‑functional communication to maintain product quality and