Ensures product quality is maintained at standards set forth by the company's quality systems and as mandated by regulatory agencies. The focus areas for the Quality Control Manager include, but are not limited to: scheduling and executing inspection, testing, and documentation of all products manufactured by the company at the Mountain View facility.
- Hire, develop, train, and evaluate QC personnel.
- Supervise and oversee QC personnel in their role for safe and efficient verification, approval, release/disposition of PCT or client products/materials.
- Ensure and promote compliance with applicable CGMP and GTP regulations and company and client SOPs.
- Work with colleagues in the Allendale facility to assure alignment and continuity in laboratory practice between sites.
- Assist in investigation and root cause analysis and oversee timely closure of deviation reports and applicable batch records,
- Ensure completion and oversee review of QC logs.
- Ensure completion of all client QC requirements related to GMP cellular product and/or material.
- Maintain good client relationships.
- Oversee QC role in material disposition via deviation reporting system or client based system if applicable.
- Prioritize, schedule and manage multiple projects and resources simultaneously.
- Monitor effectiveness of quality systems, change control activities and completion both facility and client specific.
- Evaluate and investigate customer complaints and deviations; initiate and coordinate corrective and preventive actions as they relate to the quality control function or as assigned.
- Maintain tracking and trending aspects of the deviation reporting system.
- With colleagues in the Allendale facility, develop and maintain Key Performance Metrics (KPI) for laboratory testing and evaluation.
- Interface with suppliers and in-house production personnel to ensure effective corrective and preventive actions are implemented for recurring product/process discrepancies as applicable.
- Interface with operation’s management and upper management in significant deviation resolution and corrective action implementation.
- Develop, revise and implement Standard Operating Procedures as related to Quality Control activities.
- Complete projects and special tasks as assigned.
Knowledge and Experience
- BS degree in biological sciences or equivalent.
- Minimum 5 years related experience in the pharmaceutical, biologics or related industry.
- Proven ability to lead, coach, and motivate employees, clearly communicate job requirements and effectively manage performance of assigned staff with a minimum of three years in a management position.
- Understanding of current Good Manufacturing Practices (cGMPs)
- Working knowledge of routine QC laboratory procedures such as flow cytometry and CBC analysis, endotoxin testing, equipment and systems, an understanding of production processes and validation.
- Sound knowledge of aseptic processing and supporting technologies.
- At least 3 years experience with writing, reviewing and following Standard Operating Procedures.
- Analytical and technical troubleshooting skills
- Excellent organizational skills and attention to detail.
- Good verbal and written communication skills.
- Strong team-oriented interpersonal skills are essential.
- Travel may be required.