The PositionProvide subject matter expertise in Computer Systems Validation, process improvement, and IT compliance service delivery management across the site. Ensure that IT solutions are implemented and released to use in compliance with relevant regulations and standards facilitating the seamless transition and handover of projects to service operations with key stakeholders. Ensure 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 Director / Senior Manager / Manager.
Essential Functions- Participate in all IT solutions validation activities including but not limited to: IT Infrastructure, IT Systems, and Computerized Equipment's supporting Laboratories, Manufacturing, and Business Areas like Facilities and Warehousing
- Ensure that IT solutions are compliant with relevant regulations and standards, e.g. 21 CFR Parts 11, EU Annex 11, and GAMP requirements among others
- Facilitate, review, approve and as required develop validation deliverables including but not limited to URS, DQ, FMEA, Risk Assessments, FAT, SAT, Protocols (IQ, IOQ, OQ, PQ), Operating and Maintenance Instruction
- 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 while working to identify efficiencies in the CSV program approach, applying lessons learned, and stay informed of industry regulatory changes as it applies to CSV
- Perform assigned Quality Systems activities including Document Management system, Change Control, Deviations, and CAPA's
- Writing and/or revising procedures applicable to CSV activities
- Work in collaboration with the Engineering group to prepare the validation, requalification, and maintenance program
- 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 a CSV SME in audits and inspections and provide needed documentation to demonstrate validated state and release to use
- Collaborate with cross-functional teams to ensure that all IT solutions meet business needs, are delivered on time & within budget, and are properly documented and released to use
- Ensure that all documentation and processes are following regulatory requirements and Novo Nordisk standards
- Provide leadership and expertise in IT CSV, 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
- Execute project activities and process improvement by incorporating cLEAN tools for visual management to track service delivery performance and communicate progress to stakeholders
- Utilize problem solving skills to handle deviations to ensure they are properly documented, investigated, and resolved in a timely manner, as well as ensuring subsequent changes are properly documented, assessed for impact, and implemented in a controlled manner
- Develop and deliver training programs for CSV and process improvement initiatives
- Communicate effectively with stakeholders at various levels of the organization to ensure that CSV issues, improvement opportunities, and service delivery meet business needs and are aligned with regulatory requirements and Novo Nordisk standards. Moreover, will also perform other duties as assigned
- Follow all safety & environmental requirements in the performance of duties
- Other accountabilities, 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 required
- Master's degree in IT, Engineering, Science, or relevant field of study from an accredited university preferred
- Minimum of seven (7) years of experience in IT compliance required, preferably within the pharmaceutical industry API and/or Finish Production Manufacturing
- Minimum of five (5) years of experience on Validation and Testing of IT Solutions required
- Certified Software Quality Engineer (CSQE) is preferred
- COBIT Certification is preferred
- Lean Six Sigma Green Belt or Black Belt is preferred
- Experience with electronic application lifecycle software, from requirements gathering to testing and deployment, preferrable HP ALM preferred
- Experience as SME participating in Audits and Inspections preferred
- Experience on GxP, change management and deviation handling preferred
- Experience with Incident, Problem, and Change Management in IT preferred
- Excellent writing and communication skills, in English required
- Excellent customer service skills and ability to collaborate effectively in a team environment required
- Excellent problem solving, negotiation, conflict management, and interpersonal skills required
- Excellent planning, organizing, decision making and deal with complexity and ambiguity required
- Strong computer skills and MS Office Expert required
