Pharmaceutical QA Director
$208,000–$312,000 year
On-siteTustin, California, United States
Job Summary
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.
Required Qualifications
- Bachelor's degree in Pharmacy, Chemistry, Microbiology, or a related scientific discipline
- Minimum of 10 years of experience in pharmaceutical quality assurance
- At least 5 years in a leadership role
- Demonstrated expertise in departmental leadership
- Quality control expertise
- Microbiology quality assurance expertise
- Process quality assurance expertise
- Experience within a pharmaceutical manufacturing environment
- Strong knowledge of FDA regulations
- Knowledge of cGMP guidelines
- Knowledge of other relevant regulatory requirements
- Proven experience managing drug research project quality
- Experience successfully leading regulatory inspections
- Departmental leadership skills
- Drug research project management skills
- Quality control and microbiology quality assurance skills
- Process quality assurance expertise
Desired Qualifications
- Advanced degree (Master's or PhD) in a relevant scientific field
- Certification in Quality Assurance (e.g., ASQ Certified Quality Auditor or Quality Manager)
- Experience with global regulatory agencies such as EMA, PMDA, or Health Canada
- Familiarity with electronic quality management systems (eQMS)
- Knowledge of data integrity principles
- Track record of implementing Lean or Six Sigma methodologies in quality assurance processes
- Regulatory knowledge
- Quality certifications
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