Senior Director, QA & Compliance — Sterile Injectables

Quva; Bloomsbury (NJ); Sur place; USD 164 000 - 226 000; Plein temps

Avantages offerts par ce poste

Health benefits

401k with company match

PTO plus holidays

Annual incentive bonus

Résumé du poste

Quva is seeking a Director of Quality Assurance for our Bloomsbury, NJ site to lead QA and QS, ensure regulatory compliance, and drive continuous improvement in sterile injectable manufacturing. The role oversees aseptic operations, batch release, and deviations with a focus on quality and patient safety at the site.

The position requires extensive leadership experience in cGMP environments, collaboration with cross-functional teams, and a commitment to maintaining Quva’s quality standards

Qualifications

• Bachelor’s Degree in Life Science or related field.
• Minimum 10 years experience in Quality Assurance / cGMP / FDA regulated industry.
• Minimum 5 years of supervisory or management experience.
• Experience with aseptic techniques for sterile injectable products.

Responsabilités

• Supervises QA & QS managers and develops staff.
• Maintains aseptic conditions and sterility during manufacturing.
• Manages on-time release of batches.
• Handles Deviations/Investigations, CAPAs, Change Controls with documentation.
• Ensures SOPs and training documents are in place and effective.
• Maintains environmental monitoring program and compliance with FDA 503B and CGMP.

Connaissances

Quality Assurance

Regulatory Compliance

People Management

cGMP

Aseptic Techniques

Formation

Bachelor’s Degree in Life Science or related field

Description du poste

Quva is seeking a Director of Quality Assurance for our Bloomsbury, NJ site to lead QA and QS, ensure regulatory compliance, and drive continuous improvement in sterile injectable manufacturing. The role oversees aseptic operations, batch release, and deviations with a focus on quality and patient safety at the site.

The position requires extensive leadership experience in cGMP environments, collaboration with cross-functional teams, and a commitment to maintaining Quva’s quality standards