Director of Pharmaceutical Quality & Compliance

Eliquent Life Sciences, Inc; Tustin (CA); On-site; USD 180,000 - 260,000; Full time

Job summary

ELIQUENT Life Sciences, Inc. is actively seeking a Pharmaceutical QA Director to drive quality, compliance, and continuous improvement across manufacturing and drug research activities. You will lead the QA department, ensure adherence to cGMP, and serve as the primary liaison with regulatory agencies.

The role emphasizes cross-functional leadership, risk-based decision making, and ongoing audits to safeguard product quality and patient safety.

Qualifications

• Bachelor’s degree in Pharmacy, Chemistry, Microbiology, or related scientific discipline.
• 10+ years in pharmaceutical quality assurance, including 5+ years in a leadership role.
• Leadership in QA, QC, microbiology QA, and process QA within a pharmaceutical manufacturing environment.
• Strong knowledge of FDA regulations, cGMP guidelines, and regulatory requirements.
• Experience managing drug research quality and regulatory inspections.

Responsibilities

• Lead and manage the Quality Assurance department, providing strategic direction and fostering a culture of quality and compliance.
• Oversee quality control and quality assurance processes, including microbiology and process quality assurance activities, to ensure adherence to cGMP and other regulatory standards.
• Manage and support drug research project quality requirements, ensuring that all phases of development comply with internal and external quality standards.
• Coordinate and prepare for regulatory inspections and audits, addressing any findings with effective corrective and preventive actions.
• Collaborate with manufacturing, research, and regulatory teams to develop and implement quality systems, policies, and procedures that support continuous improvement.

Skills

Leadership

Quality assurance

Microbiology QA

Process QA

FDA/cGMP knowledge

Regulatory inspections

Education

Bachelor’s degree in Pharmacy, Chemistry, Microbiology, or related science

Advanced degree (MS/PhD) preferred

Tools

eQMS

Regulatory databases

Job description

ELIQUENT Life Sciences, Inc. is actively seeking a Pharmaceutical QA Director to drive quality, compliance, and continuous improvement across manufacturing and drug research activities. You will lead the QA department, ensure adherence to cGMP, and serve as the primary liaison with regulatory agencies.

The role emphasizes cross-functional leadership, risk-based decision making, and ongoing audits to safeguard product quality and patient safety.