Global Lead, IT Compliance and Validation

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.

Although a hybrid role, the incumbent must reside near one of the following site locations: Raleigh, NC area, Billingham, UK area, Copenhagen, Denmark area

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

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.

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.

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.