Senior Specialist, Supplier Quality

Join FUJIFILM Diosynth Biotechnologies in our new facility location - Thousand Oaks, California! The Senior Specialist, Supplier Quality will report directly to the Director of Supplier Quality at the FUJIFILM Diosynth Biotechnologies California (FDBC) location. The job holder will be responsible for the training of internal and supplier audit team members. They will prepare, conduct, and report results of audits.

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 Senior Specialist, Supplier Quality supports the Cellular Therapy GMP quality program. This individual executes activities in support of the supplier quality management program including site auditing and reporting in support of preparation for commercial product manufacturing and testing of cellular therapy products.

Reports to                Director of Supplier Quality

Work Location         Thousand Oaks, CA 

Travel                        May be required (Up to 30%)

Primary Responsibilities:

• Independently prepares, conducts, and reports results of audits of GMP service providers and suppliers of various GMP materials, and internal processes to meet quality compliance requirements.
• Responsible for training of internal and supplier audit team members.
• Creates and maintains a list of approved suppliers/service providers.
• Maintain policies, procedures, checklists, self-assessment surveys, and additional forms for the internal and supplier audit programs.
• Monitors raw material supplier quality and works directly with Supply Chain, QA, and suppliers to improve performance.
• Oversee and report on the progress of audit corrective and preventative actions and audit findings for both the internal and supplier audit programs during Quality Management Meetings.
• 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

• BS/BA preferred in natural sciences.
• 8+ years of experience in pre-pivotal, pivotal and GMP commercial drug quality operations, including 2 years of experience in GMP auditor lead role and 1 year of experience supporting clinical phase cGMP Quality operations a plus.
• 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 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.
• 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.