The PositionProvide subject matter expertise in IT compliance, process improvement, and IT compliance service delivery management across the site. Ensures that IT solutions are compliant with relevant regulations and standards and facilitates the seamless transition and handover of projects to service operations with key stakeholders. Ensures governance and continuous improvement as an enabler supporting product quality, patient safety, and data integrity, and contributes to the organization's goals of improving the lives of people with chronic diseases.
RelationshipsReports to Manager.
Essential Functions- Develop and maintain validation and qualification documentation
- Conduct risk assessments and impact analyses to identify potential compliance issues and develop mitigation strategies
- Provide guidance and support to project teams on validation and qualification requirements
- Continuously monitor and improve documentation and processes to ensure compliance with regulatory requirements and Novo Nordisk standards
- Facilitate the seamless transition and handover of projects to service operations with key stakeholders
- Maintain system documentation and process according to Novo Nordisk standards and in compliance with regulatory requirements
- Participate as an IT SME in audits and inspections and provide needed documentation to demonstrate validated state and proper management of IT solutions throughout the life cycle
- Collaborate with cross-functional teams to ensure that all IT solutions meet business needs, are delivered on time & within budget, are properly documented, and managed throughout their life cycle
- Ensure that all IT solutions, documentation, and processes are following regulatory requirements and Novo Nordisk standards
- Provide leadership and expertise in IT compliance, process improvement, and project coordination
- Coach and mentor personnel, and provide guidance as needed
- Participate in process group meetings and contribute to process group activities
- Follow all safety & environmental requirements in the performance of duties
- Other duties as assigned
Physical RequirementsMay move equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. May be required to be on your feet for up to a 12 hour shift. May require corrected vision to 20/20 or 20/25 based on role. May require color vision based on role. May require the ability to work in loud noise environments with hearing protections. Ability to work in an open office environment with the possibility of frequent distraction. Ability to travel up to 10% of the time. % can change on a case-by-case basis based on the role.
Qualifications- Bachelor's Degree in IT, Engineering, Science, or relevant field of study from an accredited university with a minimum of seven (7) years of experience in IT compliance and five (5) years of experience in Validation and Testing of IT Solutions required, preferably within the pharmaceutical industry
- Master's degree in IT, Engineering, Science, or relevant field of study from an accredited university preferred with a minimum of five (5) years of experience in IT compliance and three (3) years of experience in Validation & Testing of IT solutions, required; preferable within the pharmaceutical industry
- Excellent written and verbal communication skills in English
- Strong customer service skills and ability to collaborate effectively in a team environment
- Excellent problem solving, negotiation, conflict management, and interpersonal skills
- Excellent planning, organizing, decision making and deal with complexity and ambiguity
- Strong computer skills and expert-level proficiency in Microsoft Office (MS Office)
- Preferred Qualifications:
- Certified Information Systems Auditor (CISA)
- Lean Six Sigma (Green Belt or Black Belt)
- Experience serving as an SME supporting Audits and Inspections
- Experience in GxP, change management, and deviation handling
- Experience with Incident, Problem, and Change Management in IT
