Global Lead, IT Compliance and Validation

3 weeks ago

Billingham County Durham, United Kingdom FUJIFILM Diosynth Biotechnologies Full time

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.

  • Global Lead, IT Compliance and Validation

    4 weeks ago

    Billingham, United Kingdom FUJIFILM Diosynth Biotechnologies Full time

    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...

  • Global Lead, It Compliance And Validation

    2 weeks ago

    Billingham, United Kingdom Fujifilm Diosynth Biotechnologies Full time

    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...

  • Global Lead, IT Compliance and Validation

    4 weeks ago

    Billingham, United Kingdom FUJIFILM Diosynth Biotechnologies Full time

    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...

  • Global Lead, IT Compliance and Validation

    4 weeks ago

    Billingham, United Kingdom FUJIFILM Diosynth Biotechnologies Full time

    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...

  • Global Lead, IT Compliance and Validation

    4 weeks ago

    Billingham, United Kingdom FUJIFILM Diosynth Biotechnologies Full time

    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...

  • Global IT Compliance and Validation Director

    1 week ago

    Billingham, Stockton-on-Tees, United Kingdom FUJIFILM Diosynth Biotechnologies Full time

    About the RoleAs a Global Lead for IT Compliance and Validation at FUJIFILM Diosynth Biotechnologies, you will be responsible for ensuring that our company's IT systems are compliant with regulatory requirements. This includes managing a team of experts who will oversee the validation process.Key Responsibilities• Develop and implement global validation...

  • Compliance and Validation Director

    4 weeks ago

    Billingham, County Durham, United Kingdom FUJIFILM Diosynth Biotechnologies Full time

    About the Opportunity:FUJIFILM Diosynth Biotechnologies is seeking a highly skilled Compliance and Validation Director to lead our IT compliance and validation team. The successful candidate will have extensive experience in computer system validation, documentation standards, and GAMP, with a proven track record of continuous improvement and effective...

  • Global IT Compliance Expert

    3 weeks ago

    Billingham, County Durham, United Kingdom FUJIFILM Diosynth Biotechnologies Full time

    About the Role:FUJIFILM Diosynth Biotechnologies is seeking a highly skilled Global IT Compliance Expert to lead our IT compliance and validation team. The successful candidate will have extensive experience in computer system validation, documentation standards, and GAMP.The ideal candidate will be responsible for developing global validation teams and...

  • IT Compliance and Validation Manager

    3 weeks ago

    Billingham, Stockton-on-Tees, United Kingdom FUJIFILM Diosynth Biotechnologies Full time

    Job SummaryWe are seeking an experienced Senior Validation Specialist to join our Global IT Team as the Lead for IT Compliance and Validation. As a key member of our organization, you will be responsible for developing and implementing robust validation processes across our global operations. The successful candidate will have a strong background in computer...

  • Global IT Compliance and Validation Lead

    3 weeks ago

    Billingham, Stockton-on-Tees, United Kingdom FUJIFILM Diosynth Biotechnologies Full time

    About FUJIFILM Diosynth Biotechnologies">We are a trusted Contract Development and Manufacturing Organization (CDMO) partner for life, committed to transforming people's lives and making a meaningful impact. Our company is united by Genki, a mindset that inspires us to push boundaries and strive for excellence.FUJIFILM Diosynth Biotechnologies is a global...

  • Senior Validation Leader

    3 weeks ago

    Billingham, County Durham, United Kingdom FUJIFILM Diosynth Biotechnologies Full time

    About FUJIFILM Diosynth Biotechnologies:We are a trusted CDMO partner for life, committed to transforming people's lives and impacting where it matters most. As a global company united by Genki, we encourage you to discover what inspires you every day and follow your passion and power.This exciting opportunity as a Senior Validation Leader will provide you...

  • Senior Validation Specialist

    3 weeks ago

    Billingham, Stockton-on-Tees, United Kingdom FUJIFILM Diosynth Biotechnologies Full time

    About the JobWe are looking for a highly motivated and experienced professional to lead our IT Compliance and Validation team. As the Senior Validation Specialist, you will be responsible for ensuring compliance with regulatory requirements, developing and implementing effective validation processes, and mentoring junior team members.The ideal candidate will...

  • Senior Compliance Officer

    7 days ago

    Durham, United Kingdom CK Group- Science, Clinical and Technical Full time

    About the RoleWe are seeking a Senior Compliance Officer to lead regulatory efforts for our global markets. The ideal candidate will have a strong background in regulated environments, particularly in personal and household care, cosmetics, and biocidal products.This role requires expertise in US and EU legislation, with a focus on product compliance and...

  • Global Compliance Specialist

    1 week ago

    Durham, Durham, United Kingdom Austin Fraser Full time

    Job Summary:">Austin Fraser is recruiting for a Global Compliance Specialist to oversee regulatory affairs across multiple markets.">About the Company:">A leading global chemical manufacturer, Austin Fraser specialises in developing and producing personal care and laundry care products.">About the Role:">The successful candidate will be responsible for...

  • Director of IT Risk Management and Validation

    1 week ago

    Billingham, Stockton-on-Tees, United Kingdom FUJIFILM Diosynth Biotechnologies Full time

    Job OverviewFUJIFILM Diosynth Biotechnologies is seeking an experienced IT professional to lead our IT Compliance and Validation team. As a Senior Manager of IT Governance and Compliance, you will be responsible for ensuring that our company's IT systems are secure and compliant with regulatory requirements.Responsibilities• Develop and implement policies...

  • PFI Compliance and Performance Lead

    3 weeks ago

    Durham, Durham, United Kingdom 300 North Limited Full time

    PFI Compliance and Performance LeadWe have an exciting opportunity for a senior professional to deliver compliance monitoring requirements while supporting performance improvement initiatives on a PFI Facilities Management contract.Key Responsibilities:• Ensure adherence to regulatory and contractual obligations through effective compliance monitoring.•...

  • Global Regulatory Lead

    2 weeks ago

    Durham, Durham, United Kingdom CK Group Full time

    ResponsibilitiesDeliver and maintain compliant regulatory applications for Biocides and Detergents while working with a third-party RP for Cosmetics.Work with the brand team to define the regulatory route to market for new products and their ongoing compliance and market attractiveness.Develop and implement regulatory strategies for New Product Development...

  • Senior Regulatory Compliance Officer

    4 weeks ago

    Durham, County Durham, United Kingdom CK Group Full time €50,000 - €60,000

    CK Group are recruiting for a Senior Regulatory Affairs Officer, to join a global chemical manufacturing company, at their facilities located near Durham, on a permanent basis. This role will offer hybrid working (3 days onsite/ 2 days WFH) Our client is a leading chemical manufacture, specialising in developing and producing personal care and laundry...

  • Technical Assessment Engineer

    2 months ago

    Billingham, County Durham, United Kingdom Risktec Solutions Ltd Full time

    Technical Assessment Engineer United Kingdom £Competitive plus pension scheme, flexible working options, and company car allowance The Role: Due to expansion in our sister company TUV Rheinland Industrial Services (TRIS), a brand new role has opened for a Technical Assessment Engineer to work with the Head of Notified Body. The Technical Assessment...

  • Quality Assurance and Compliance Lead

    3 weeks ago

    Billingham, Stockton-on-Tees, United Kingdom Exposed Solutions Full time

    Job Overview:The Exposed Solutions company is looking for a highly skilled professional to fill the role of Quality Assurance and Compliance Lead. This position requires expertise in quality assurance, security management, and environmental compliance.Responsibilities:- Implement integrated management systems- Ensure compliance with relevant standards and...