IT Validation & Compliance Lead (Onsite)

Essential Functions

• Computer Systems Validation Expert
  Involves in all IT solutions validation activities what includes but is 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 what includes but is 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.
• Service Delivery Management
  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 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 are properly documented and released to use
  Ensure that all documentation and processes are following regulatory requirements and Novo Nordisk standards

Leadership and Collaboration

• Provide leadership and expertise in IT CSV, process improvement, and project coordination
  Collaborate with cross-functional teams to ensure that IT solutions meet business needs and are delivered on time and within budget
  Coach and mentor personnel, and provide guidance as needed
  Participate in process group meetings and contribute to process group activities
  Ensure that all activities are aligned with Novo Nordisk Way Essentials and support the organization's mission to improve the lives of people with chronic diseases

Problem Solving and Training

• Handle deviations ensuring that deviations are properly documented, investigated, and resolved in a timely manner
  Plan ensuring that changes are properly documented, assessed for impact, and implemented in a controlled manner
  Develop and deliver training programs for CSV and process improvement initiatives

Qualifications

• Education and Certifications: Bachelor's degree in Information Technology or related field of study from accredited college or university with a minimum of seven (7) years of experience in IT compliance, preferably within the pharmaceutical industry API and/or Finished Production Manufacturing, required
  Master’s degree in Information Technology or related field of study from accredited college or university preferred with a minimum of five (5) years of experience in IT compliance, preferably within the pharmaceutical industry API and/or Finished Production Manufacturing, required
  COBIT Certification is preferred
  Lean Six Sigma Green Belt or Black Belt is preferred
• Experience: Five (5) years of experience in Validation & Testing of IT solutions, required
  Experience with electronic application lifecycle software, from requirements gathering to testing and deployment, preferable HP ALM, required
  Experience as SME participating in Audits and Inspections, required
  Experience on GxP, change management and deviation handling, required
  Experience with Incident, Problem, and Change Management in IT, required
• Skills: 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