FUJIFILM

Director, Quality Systems and Compliance

Job Locations US-CA-Thousand Oaks
Posted Date 2 months ago(6/24/2022 11:53 AM)
Requisition ID
2022-20528
Category
Information Technology
Company (Portal Searching)
FUJIFILM Diosynth Biotechnologies

Overview

Join FUJIFILM Diosynth Biotechnologies in our new facility location - Thousand Oaks, California! The Director, Quality Systems and Compliance report directly to the Director, Quality at the FUJIFILM Diosynth Biotechnologies California (FDBC) location. The job holder will be responsible for Quality Systems and Compliance. They will lead the Quality Systems and Compliance Team.

External US

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 FDB 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 Director, Quality Systems and Compliance will lead a Quality Systems and Compliance Team ensuring implementation of a phased appropriate program. This individual will simultaneously lead implementation of a quality system structure and will be a quality expert for compliance and compliance related activities at the site. The Director, Quality Systems and Compliance will also support cross functional teams for inspection readiness, due diligence activities, and quality system processes.  

 

Reports to                 Director, Quality

Work Location          Thousand Oaks, CA 

Travel                        May be required (up to 25%)

 

Primary Responsibilities:

  • Responsible for Quality Systems and Compliance including Deviation, CAPA, Change Control, Risk Management, Training, Document Management, Regulatory and Management Responsibilities.
  • Define the Quality Systems and Compliance strategy to support business requirements.
  • Lead a Quality Systems and Compliance team.
  • Support GMP system, and process improvement initiatives. Lead continuous process improvement within Quality, by providing directives, and representation on project work-streams as required.
  • Responsible for training of Quality Systems and Compliance team members.
  • Maintain policies, standards and procedures for the Quality Systems and Compliance functions.
  • Oversee development of metrics and Management Review.
  • Supports Quality management contact with the FDA, EMA, and other regulatory authorities worldwide, as well as partners regarding quality issues including field alerts, recalls, or regulatory actions.
  • Supports GMP inspections and audits from both regulatory authorities and partners and supports drafting of follow-up responses for all aspects of the business.
  • Supports other GXP functions as required.

Qualifications

  • Bachelor’s Degree in Natural Sciences preferred.
  • 10+ years direct experience, or related experience in Quality or Quality Management Systems.
  • 8+ years of experience in pre-pivotal, pivotal, and GMP commercial drug quality operations. 2 years of experience supporting clinical phase cGMP Quality operations is a plus.
  • 5+ years’ experience managing teams.
  • Solid understanding of quality management systems and continuous process improvement principles including global cGMP requirements and other relevant regulations and guidance to assure quality products.
  • Expertise 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.
  • Experience with commercial facility pre-approval inspection (PAI) and PAI readiness planning is a plus.
  • Demonstrated ability to work in a multi-disciplinary setting, acting as a facilitator to drive fulfillment of strategic goals.
  • Background in continuous improvement and implementation of quality metrics.
  • Certification/training in applicable quality management disciplines preferred.
  • 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 and different settings.
  • Sound organizational skills.
  • Possesses sense of urgency; identifies challenges and problems and takes the initiative to identify solutions.
  • Motivates team members, fosters and nurtures teamwork.
  • Project management skills and focus on delivery of results.
  • Role model for company core values of trust, delighting our customers, Gemba, and Genki.

Join us!  FDB 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.

 

FDBC is an equal opportunity employer to all, regardless of age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, religious creed, sex (includes pregnancy, childbirth, breastfeeding, and related medical conditions), and sexual orientation and any other status protected by state or federal law.

 

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.

 

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