Senior Director, Quality Management Systems Content Owner

Overview

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. 

External US

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