The Sr. Director Quality Management System (QMS) content owner is accountable to ensure that content of global QMS processes are compliant and designed proactively to support business aspirations (e.g. KojoX, digitalization and use of AI) and regulatory trends. In this role, you will be fully empowered to decide on design and enhancement of core processes and to recommend solutions for future QMS initiatives to drive compliance, business and operational improvements for the company. 

FUJIFILM Diosynth Biotechnologies is an industry leading Contract Development and Manufacturing Organization (CDMO) with locations in Teesside, United Kingdom; RTP, North Carolina; Holly Springs, North Carolina; Thousand Oaks, California; Hillerød, Denmark; and College Station, Texas. We use our skills, dedication, and ambition to enable impact for the world’s most innovative biotech and biopharma companies reimagining healthcare’s potential. We work across the entire lifecycle of our customer’s products – enabling success throughout. Every cure, vaccine, biologics, and advancement we contribute to starts with our people and our passion.  

This is a global position that will support all sites. The incumbent must reside near one of our sites around the globe. Benefits and compensation will be governed by the location that you are based from and considered your home site.

Main Responsibilities and Activities:

• Establish, lead, maintain and improve the corporate network of business process owners (BPOs), quality system owners (QSOs) and site functional leads to ensure cross-site understanding and support of content of new EDMS (Veeva)
• Take on the role as global QMS content owner and ensure that quality deliverables are provided according to Veeva project implementation and future operational schedule
• In collaboration with regulatory ensure that the QMS content is current with and proactively incorporate upcoming regulatory guidelines to maintain, improve and innovate FDB strategy and state of compliance
• Responsible for keeping team engagement, timeline and budget while implementing the EDMS, QMS and Training modules of Veeva
• Ensure that key stakeholders across the organization (BPOs, QSOs, functional leads) are informed and consulted when appropriate to ensure the QMS content is understood and supported across the FDB organization
• Assume quality ownership for Veeva system.

Long term vision for this role is to form the foundation for FDB to be ahead of the industry as it pertains to use of digital solutions and artificial intelligence in shaping the QMS processes of the future.

• Ensure all needed quality processes are migrated simplified and effectively from existing QMS structure (e.g. document hierarchy, document types etc.) and systems (Master Control Trackwise, Compliance wire) to Veeva. This includes governance, timeline and budget adherence and appropriate communication to all stakeholders - 70%
• Internal audit and inspection readiness coaching and execution as needed, act as QMS expert during site inspections across the network - 10%
• Ensure participation in industry foras to keep up to date with latest trends within assigned area of responsibility 5%
• Participate in other assigned Quality tasks (e.g. conduct risk assessments, corporate audits, Generate quality assessments and reports for assigned topics, run quality foras e.g. QMRs, risk register meetings etc.) 15%
• And other job duties that may be assigned from time to time (Can include cross function collaborative and project team leadership assignment consistent with personal strategic, operational and technical leadership) - 5%

This role has accountability above sites pertaining to Quality Management System Content and is accountable for designing and driving the QMS strategy for Quality, in close collaboration with  and Regulatory. In this role stakeholders are on all sites and the role has interaction to a broad spectrum of customers as well in the co-design of data governance models. This role will have significant impact to the FDB strategy of transforming the industry and will be consulted as the role having the latest regulatory and business trends for QMS. Unprecedented delivery is also heavily impacted by the success of this role as accountable for the quality processes robustness and compliance.

Background Requirements:

• Scientific Master’ s degree (i.e. biotechnology, engineering, pharmaceutical science)
• 15+ years of leadership in Quality Management Systems and excellent understanding of business processes and how they are translated to digital solutions. Experience includes leading sites to a quality mindset that adheres to the regulations.

• Solid experience hosting inspections and audits and to comfortably be responsible for presenting

• 10+ years working in a management role (this role will manage 1-5 direct reports)

• Experience working in the Biopharmaceutical industry

• Experienced in the application of change and risk management tools and methodologies

• Experienced in human performance processes

• In depth knowledge about the EUDRALEX and FDA CFR regulations across all product stages (DS, DP, FG)
• Excellent verbal and written communication skills
• Proven ability to influence, negotiate and persuade, especially at a senior level
• Ability to present complex information in a clear and concise manner
• Ability to adjust personal style when dealing with different individuals
• Has a collaborative approach to tasks with a focus on driving good behaviours and attitudes through leadership style coaching

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 FDBUHR@fujifilm.com. 

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.