Sr. Manager, Manufacturing Quality Assurance

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 FDB and help create the next vaccine, cure, or gene 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 FDB call Genki.

We are seeking a highly motivated individual to join us as a Sr. Manager, Manufacturing Quality Assurance. This role is accountable for developing and leading a collaborative manufacturing quality assurance (MQA) team, supporting site operations.

This team will have direct quality oversight of FDBU manufactuing and operations, ensuring the site is in compliance with relevant quality, regulatory and corporate / site policies and procedures.

External US

MAJOR ACTIVITIES AND RESPONSIBILITIES :

• Ensure training and development of staff to support manufacturing operations, review of batch specific documentation, manufacturing deviations, change controls and CAPAs to assure compliance with license, site as well as global polices, and relevant cGMP regulatory requirements.
• Maintain and promote a quality compliant culture, ensuring the highest standards are applied within all manufacturing and operation areas at the FDBU site through implementation of quality walk-throughs and on the floor presence
• Enforce compliance with FDB and FDBU safety, quality, compliance, and regulatory standards
• Support site regulatory inspections and client audits as required
• Act as the quality partner to manufacturing, operations, and quality RPs to support assessment of manufacturing related deviations, change controls and CAPAs
• Set and manage department needs related to staffing, hours, training, development and required job functions to ensure site meets schedules, project timelines and goals.
• Manage team responsible for review of batch records, log books and related data to assure quality and regulatory compliance to support batch disposition.
• In conjunction with RPs, serve as a quality subject matter expert and decision maker for real time issue resolution within manufacturing and operations.
• Own and facilitate manufacturing triage meetings
• Establish quality oversight and process for manufacturing analytical equipment and critical alarm review / response.
• Support review, approval and closure of manufacturing related events and change controls
• Ensure collaboration of the MQA team with internal and external departments, including the FDB global network.
• Acquire and maintain up-to-date knowledge of regulatory requirements for cGMP and ensure knowledge and understand throughout the MQA team.
• Act as delegate for Quality Operations as needed
• Support site continuous improvement efforts.
• Develop, measure and report team KPIs in support of site and departmental goals
• Ownership of client programs as a responsible person as required

BACKGROUND REQUIREMENTS :

• Bachelor’s degree in related scientific field or equivalent of 10 years experience within the CDMO, biopharmaceutical industry in the manufacturing and or quality organization.
• Previous management experience within manufacturing, operations or quality required
• Demonstrated knowledge of cGMP, FDA requirements, and Quality Systems knowledge
• Previous experience in ownership and / or approval of deviations, CAPAs and change controls, and batch record review required.

FDBU works with technical data, technology and materials that are subject to U.S. export laws and regulations. This position will require access to technical data, technology and source code that is controlled under U.

S. export laws and regulations, including but not limited to the International Traffic in Arms Regulations at 22 C.F.R. Parts 120 130 and Export Administration Regulations in 15 C.

F.R. Part 730 774, as may be amended. To conform to these laws and regulations, applicants must be U.S. citizens, lawful permanent residents of the U.

S., protected individuals as defined by 8 USC 1324(b)(a)(3) (i.e., asylees and refugees) or otherwise eligible for an export authorization from the U.

S. Department of State or U.S. Department of Commerce. Offers of employment will be contingent on the Company’s ability to secure an export authorization.

FDBU is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class.

If an accommodation to the application process is needed, please e-mail

[email protected]

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.