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.

Join us! FUJIFILM Diosynth Biotechnologies is advancing tomorrow’s medicine, impassioning employees to chase the impossible and continually expand their potential. We are a company of emboldened goal seekers – driven by an innate desire to better ourselves, our families, our workplace, our company, our community, and the world at large. 

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 programs and media simulation studies
• Experience with cGMP, manufacturing, and testing requirements as they relate to biologics, experience with cell therapy processes a plus
• Demonstrated ability to work in a multi-disciplinary setting
• Strong scientific/technical skills
• Ability to anticipate and resolve problems effectively
• Strong verbal communication and technical writing skills
• Ability to present clearly using scientific and clinical terminology
• Strong interpersonal skills and the ability to communicate effectively with people in diverse settings
• Sound organizational skills
• Possesses sense of urgency; identifies challenges and problems and takes the initiative to identify solutions
• Project management skills and focus on delivery of results
• Role model for company core values of trust, delighting our customers, Gemba, and Genki

Salary and Benefits:

• $104,000 to $130,000 per year, depending on experience
• Medical, Dental and Vision
• Life Insurance
• 401k
• Paid Time Off

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBCHR@fujifilm.com).