Global Lead for IT Compliance & Validation

As the Global Lead for IT Compliance & Validation, you will help set the overall Computerized System Validation (CSV) strategy and delivery support methodology for the Global CSV team, in addition to ensuring appropriate validation this role will also have responsibility for vendor assurance and customer/regulatory audit coordination for the IT team. In this role, you will provide guidance and mentorship to the CSV team and the broader IT organization, and ensure a collaborative dialogue with QA/ITQ to ensure common understanding of our ITQMS and lifecycle requirements.

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. The work we do has the potential to transform people’s lives and to impact where it matters most. Each day is an opportunity to push the boundaries of your potential, so join our Global IT Team as the Lead for IT Compliance and Validation and become part of a fast-growing global company, united by Genki.

The Global leader of IT Compliance & Validation is not directly accountable for a separate budget but will contribute to the budget process and is responsible for transparency of cost and continuous optimization in their unit. The role includes responsibility for the management and development of the direct reports – in respect to quality of deliverables and cooperation. ​As a Global Leader you will be responsible for a global team of between 3-8 direct reports – potentially situated across geographic sites. The role includes taking responsibility for delivery and services with impact to business units.

You will have the opportunity to work in close relationship with other leaders cross sites and IT functional towers.

Principal Accountabilities:

• Develop global validation team and supporting global processes.
• Support the organization and computerized system validation team on compliance and regulatory requirements. Mentorship of internal resources.
• Continuous improvement of CSV delivery methodologies, internal processes and collaboration with ITQ.
• Develop vendor assurance practice.
• Verify external CSV resource requirements and deliverables.
• Coordinate IT audit responses supporting customer and regulatory agency audits and inspections.

Background and Education Requirements:

• Bachelor’s degree in engineering, computer science or similar is required
• 10+ years industry relevant experience in computer system validation
• Must also have strong knowledge of documentation standards in particular ISO and cGMP
• A proven understanding of GAMP
• A high level of understanding within production and IT Projects
• Proven team management​ experience. Ability to lead and develop/mentor a team
• Excellent communication and interpersonal skills, with the ability to effectively communicate with technical and non-technical stakeholders

Desired Experience:

• Knowledge and experience within the Pharmaceutical industry
• Overall understanding of the IT strategy and how it supports the business strategy​
• Must be able to present topics with authority to auditors

Has this shaken your interest, then please apply as soon as possible and latest by the 19th of January. This is a global position and can be based at any of our locations or remotely. We have European offices located in the United Kingdom (Teesside) and Denmark (Hillerød). Benefits and compensation will be governed by the location that you are based at and considered your home site.

As part of any recruitment process, FUJIFILM Diosynth Biotechnologies collects and processes personal data relating to job applicants. The organisation is committed to being transparent about how it collects and uses that data and to meeting its data protection obligations and may share this as part of the global recruitment process with hiring managers in Europe and the United States.

About FUJIFILM Diosynth Biotechnologies:

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.

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.

Location: FDBD Hillerod