QA Manager
$122,500–$149,400 year
On-sitePomona, California, United States
Job Summary
Lead quality systems and compliance activities to support product delivery and regulatory readiness, ensuring adherence to cGMP, QSR, GDP, and other applicable standards. Oversee quality-related investigations, audits, customer support, and continuous improvement initiatives while managing a team of QA Associates. Liaise with customers to manage quality requests and specifications, and lead internal audits, Health Authority inspections, and customer audits. Manage investigations into batch discrepancies and out-of-specification events, ensuring root cause analysis and corrective actions are completed. Monitor quality system performance through KPIs and publish metrics with recommendations for improvement. Provide direction to direct reports regarding priorities, trials, audits, and client visits, while achieving financial objectives through budget forecasting and variance analysis. Work in warehouse and production environments with exposure to noise, chemicals, and machinery, requiring PPE in certain areas.
Required Qualifications
- 5–7 years of experience in a regulated pharmaceutical industry, including Quality Assurance and Quality Control
- Minimum 2–3 years in a leadership role
- BSc degree in scientific discipline
- Strong knowledge of cGMP, Quality Systems, Drug Regulatory Affairs, and stability protocols
- Proven leadership and communication skills across all organizational levels
- Ability to manage competing priorities in a fast-paced environment
- Must be able to lift up to 50 pounds
- Must be available for work outside regular hours or weekends
- Demonstrated ability and concern that one be perceived as responsible, reliable and trustworthy
- Ability to work jointly with others or together especially in an intellectual endeavor
- Identifying what needs to be done and doing it before being asked or before the situation requires it
- Process of thinking about and organizing the activities required to achieve a desired goal
- Assignment of authority to another person to carry out specific activities
- Convey confidence in employee's ability to be successful
Desired Qualifications
- MS degree or MBA
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