Director of Pharmaceutical Quality & Compliance

Clark & Enersen; Tustin (CA); On-site; USD 138,000 - 207,000; Full time

Job summary

ELIQUENT Life Sciences in the United States seeks a Pharmaceutical QA Director to lead quality assurance across manufacturing and drug research programs, ensuring cGMP compliance and robust systems. Based in Tustin, CA, this role drives strategy, audits, and continuous improvement to safeguard product quality and patient safety.

The director collaborates with cross‑functional teams, regulators, and external partners to prepare for inspections and implement effective CAPAs, fostering a culture of

Qualifications

• Bachelor’s degree in Pharmacy, Chemistry, Microbiology, or related scientific discipline.
• 10+ years of pharmaceutical quality assurance experience, including at least 5 years in a leadership role.
• Strong knowledge of FDA regulations, cGMP guidelines, and other regulatory requirements.
• Experience managing drug research project quality and leading regulatory inspections.

Responsibilities

• Lead the Quality Assurance department and set strategic quality direction.
• Oversee QC and QA processes including microbiology and process QA.
• Manage drug research project quality across development phases.
• Coordinate regulatory inspections and implement CAPAs.
• Collaborate with manufacturing, research, regulatory teams to improve quality systems.

Skills

Leadership

Quality Assurance

Regulatory knowledge

FDA regulations

Audits & inspections

Education

Bachelor’s in Pharmacy, Chemistry or Microbiology

Job description

ELIQUENT Life Sciences in the United States seeks a Pharmaceutical QA Director to lead quality assurance across manufacturing and drug research programs, ensuring cGMP compliance and robust systems. Based in Tustin, CA, this role drives strategy, audits, and continuous improvement to safeguard product quality and patient safety.

The director collaborates with cross‑functional teams, regulators, and external partners to prepare for inspections and implement effective CAPAs, fostering a culture of