IT Validation & Compliance Lead; Onsite

Position

The purpose of Lead IT Validation & Compliance position is to provide subject matter expertise in Computer Systems Validation, process improvement, and IT compliance service delivery management across the site. This position ensures 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.

It plays a critical role in ensuring 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. This is an onsite based position at our GMP bioproduction facility in West Lebanon, NH.

Reports to:

Sr. Manager, IT Operations

• Computer Systems Validation Expert
  • Involved 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 standards. Work to identify efficiencies in the CSV program approach. Work to apply 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
• CSV Service Delivery Management
  • Facilitate the seamless transition and handover of projects to service operations with key stakeholders
  • Maintain system documentation and process according to 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 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 Way Essentials and support the organization's mission to improve the lives of people with chronic diseases
• The role will spend the majority of its time on project activities and process improvement within these areas of accountability (key essential functions above), incorporating cLEAN tools for visual management to track service delivery performance and communicate progress to stakeholders;
  Problem solving, handling deviations ensuring that deviations are properly documented, investigated, and resolved in a timely manner, and planning ensuring that changes are properly documented, assessed for impact, and implemented in a controlled manner. It also develop and deliver training programs for CSV and process improvement initiatives
• Responsible for communicating effectively with stakeholders at various levels of the organization to ensure…