FUJIFILM Diosynth Biotechnologies
We are a trusted CDMO partner for life. At FUJIFILM Diosynth Biotechnologies (FDB), we encourage you to discover what inspires you every day, to follow your passion and your power – what we call Genki.
About Us
We are a dynamic global company and our focus is to combine technical leadership in cell culture, microbial fermentation and gene therapies with world class cGMP manufacturing facilities to advance tomorrow’s medicines.
With sites in Billingham & Wilton UK, Hillerod Denmark, RTP and Holly Springs, North Carolina; College Station, Texas; and Thousand Oaks, California, our teams are proud to partner with innovative companies reimagining what’s possible in biopharmaceuticals. Every day at FDB is a day for improvement, each challenge is an opportunity for growth, and every moment is a chance to evolve together.
Role & Responsibilities
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. This role will manage 1 - 5 direct reports.
This includes, but is not limited to, the following elements:
- 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.
Qualifications and Experience
- 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
Why work with us?
At FDB, your passion – your Genki – is your power and we empower you to define what Genki means to you.
When you join us, we will train, develop and support you to become the best you can possibly be. We offer a structured new starter induction programme as well as on-going development training. In addition to this, we offer:
- Competitive salary plus company bonus scheme
- 35 days of holiday, plus bank holidays.
- Salary Sacrifice scheme offering, healthcare, bikes, dental etc.
- Generous pension scheme
- Free parking and electric charging points
Closing date 11th August 2024
Why Work in Billingham