Specialist Quality Assurance, Compliance

Overview

The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join our new FDBC facility in Thousand Oaks, CA and help manufacture the next cell therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki. The Specialist QA, Compliance supports the Cellular Therapy GMP quality program. This individual is responsible for the management of the Internal Quality Audit Program and facilitates Client Audits and supports Regulatory Agency Inspections. Acts as business process owner (BPO) for the Audits and Inspections process and Risk Management Process

External US

 

Specialist QA, Compliance

 

 

The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join our new FDBC facility in Thousand Oaks, CA and help manufacture the next cell therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki.

 

The Specialist QA, Compliance supports the Cellular Therapy GMP quality program. This individual is responsible for the management of the Internal Quality Audit Program and facilitates Client Audits and supports Regulatory Agency Inspections. Acts as business process owner (BPO) for the Audits and Inspections process and Risk Management Process.

 

Specific responsibility for Audits and Inspections: establishing, implementing, monitoring and reviewing the self inspection process; developing, approving, and maintaining the self inspection schedule; ensuring lead auditors and auditors have appropriate qualifications, and facilitating and coordinating activities for external audits and inspections.

Specific responsibility for Risk Management: maintaining the Risk Management SOP and related training, owning and updating the Risk Register, Facilitating Risk Assessments and maintaining a list of qualified Risk Facilitators.

 

Reports to Associate Director of Compliance

Work Location Thousand Oaks, CA

Travel Not required

 

Primary Responsibilities:

• Business Process Owner for Audits and Inspections
• Sets the requirements for the Self Inspection Program
• Defines the Self Inspection Schedule
• Manages training for Internal Auditors
• Supports training for external inspection support staff
• Develop a pool of internal auditors
• Supports the Inspection Readiness Program
• Facilitates and coordinates Client audits; supports regulatory agency inspections
• Maintain policies, procedures for the Self Inspection and Risk Management Programs
• Monitors and reports on compliance to commitment dates
• Supports GMP inspections and Client audits and supports drafting of follow-up responses for all aspects of the business
• Risk Assessment Facilitator
• Develops a pool of Risk Facilitators
• Updates and maintains the Risk Register
• Reports on Major and Critical risks and risk mitigations
• Supports site operations on risk tool selection
• Supports other GXP functions as required

 

Qualifications

• Master of Science (M.Sc.) with 2+ years of applicable industry experience; or
• Bachelor of Science (B.Sc.) with 4+ years of applicable industry experience; or
• Associate Degree with 6+ years of applicable industry experience; or
• High school diploma with 9+ of applicable industry experience
• Experience with commercial facility pre-approval inspection (PAI) and PAI readiness planning a plus
• Experience with Risk Management a plus
• Experience with Regulatory Intelligence a plus
• Solid understanding of quality management systems and continuous process improvement principles including global cGMP requirements
• Working knowledge in the cGMP requirements pertaining to sterile drug product manufacturing operations in the United States and globally in support of global clinical and commercial production activities
• Experience in aseptic technique/operations, clean room procedures/processes, environmental monitoring pro