Quality Compliance Specialist

Takeda•Thousand Oaks, CA

2d•Onsite

About The Position

This Quality Compliance Specialist is responsible for managing external regulatory inspections and responding to regulatory observations while leading GMP compliance projects. How you will contribute: 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 important. Promote 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 the point person for regulatory intelligence and changes that affect 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.

Requirements

Bachelor's degree in science or engineering preferred.
Minimum 5 years of experience in Quality.
Experience with quality auditing and with process improvement tools ideal
Knowledge and understanding 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/aseptic processing is preferred.
Decision-making, influencing, and negotiation skills.
Partner with higher levels of management across all departments and maintain site compliance.
Project management skills and the ability to create and deliver presentations to mixed audiences.
Ability to adapt in a constantly evolving and fast-paced environment.
Experience with Microsoft Office applications.

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.
Promote 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 the point person for regulatory intelligence and changes that affect 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.