Quality Compliance Specialist

Role Summary

This Quality Compliance Specialist manages external regulatory inspections and responds to regulatory observations while leading GMP compliance projects. Location: USA - CA - Thousand Oaks - Rancho Conejo.

Responsibilities

• Manage external regulatory inspections, lead local inspection readiness efforts, oversee inspection and support rooms, escorting regulatory agents, and serve as a subject matter expect during inspections.
• Draft responses to regulatory inspection reports, collaborating with multiple departments under short deadlines to ensure accurate and appropriate responses. Editing skills are necessary.
• Guide on-time completion of corrective action commitments made to regulatory authorities.
• Coordinate efforts associated with GMP re-certification and product licensing.
• Lead projects to mitigate top GxP compliance risks, providing consultation, guidance, and serving as a plant resource for facility compliance.
• Be a point person for regulatory intelligence and changes that influence the site. Communicate relevant regulatory findings from other sites. Lead mitigation efforts and identify site gaps based on other site's findings and global documents.
• Participate in local cGMP walkthroughs and conduct quality audits to ensure compliance with cGMPs and Quality Management System requirements.
• Participate in Quality Management Review program, lead Self-Inspection program and be the site contact for Quality Incident.
• Champion and role model our Quality Culture of continuous improvement, learning organization principles and progress.
• Follow domestic and international GMP regulations and cGMPs.
• May lead continuous improvement teams (e.g. DMAIC, Lean, Kaizen), improving quality and compliance.
• Be an area department contact and back-up when Quality Compliance Manager is not present.
• Support product complaints.

Qualifications

• Minimum 5 years of experience in industry.
• Experience with quality auditing and with process improvement tools ideal.
• Knowledge of global cGMP regulations and quality systems requirements for pharmaceutical or biopharmaceutical operations.
• Knowledge of biologic manufacturing processes (e.g. cell culture, purification, aseptic filling), laboratory operations (analytical and microbiology), and plant critical systems.
• Knowledge of sterile product and aseptic processing.
• Decision-making, influencing, and negotiation skills.
• Effectively partner with higher levels of management across all departments and possess courage of conviction to improve site compliance.
• Adapt in a constantly evolving and fast-paced environment.

Skills

• Project management skills and the ability to create presentations to mixed audiences.
• Experience with Microsoft Office applications.

Education

• Bachelor's degree in science or engineering recommended.

Additional Requirements

• Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
• Need to remove all make-up, jewelry, contact lenses, nail polish or artificial fingernails while in the manufacturing environment.
• Work in a cold, wet environment.
• Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
• Overall physical exertion of this position is mostly sedentary, with some light physical work.
• Able to occasionally visit controlled or clean room environments requiring gowning. Will be required to follow gowning requirements and wear protective clothing overhead, face, hands, feet, and body.
• Although assignments will be made specific to working hours, flexibility is expected, with the understanding that there may be changes in work hours, duties, and responsibilities.