Director, Quality Operations - QA & Systems

Kindeva; Simi Valley (CA); On-site; USD 180,000 - 260,000; Full time

Job summary

Kindeva Drug Delivery seeks a Quality Director to lead Quality Assurance and Quality Systems at the Northridge facility. The role drives batch disposition, deviations, CAPAs, and regulatory readiness, partnering with Manufacturing, Engineering, and Supply Chain to ensure compliant, high‑quality production for transdermal and inhalation products.

The ideal candidate has 15+ years of GMP quality leadership within pharma/CDMO environments and a track record in inspections and continuous improvement

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Engineering or related discipline.
• 15+ years of GMP quality experience in pharma/biologics/medical device or CDMO environments.
• Experience leading Quality Operations or QA organizations for commercial manufacturing.
• Experience supporting regulatory inspections and customer audits with successful outcomes.

Responsibilities

• Lead QA and Quality Systems activities for commercial manufacturing, packaging, testing, and release.
• Oversee batch record review, product disposition, and investigation processes.
• Ensure compliance with FDA/EMA/ICH/ISO13485 requirements and quality agreements.
• Drive continuous improvement and right‑first‑time quality across operations.
• Develop and mentor quality staff and manage budgets and resources.

Education

Bachelor's degree in Life Sciences, Pharmacy, Engineering

Advanced degree preferred

Job description

Kindeva Drug Delivery seeks a Quality Director to lead Quality Assurance and Quality Systems at the Northridge facility. The role drives batch disposition, deviations, CAPAs, and regulatory readiness, partnering with Manufacturing, Engineering, and Supply Chain to ensure compliant, high‑quality production for transdermal and inhalation products.

The ideal candidate has 15+ years of GMP quality leadership within pharma/CDMO environments and a track record in inspections and continuous improvement