IT Validation & Compliance Lead (Onsite)

The 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.

Relationships

Reports to: Sr. Manager, IT Operations

Essential Functions

• 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 that CSV issues, improvement opportunities, and service delivery meet business needs and are aligned with regulatory requirements and standards. Moreover, will also perform other duties as assigned

• Other duties as assigned
• Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations and industry codes
• Incorporates the Way and 10 Essentials in all activities and interactions with others

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 Finish 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
  • Minimum of five (5) years of experience in Validation & Testing of IT solutions, required
  • 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, 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
  • 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

Physical Requirements

0-10% overnight travel required. This position may lift up to 33lbs/15kg occasionally, and/or up to 10 pounds frequently or constantly to lift, carry, push, pull or otherwise move objects. Repetition including substantial movement of wrists, hands, and or fingers. The ability to speak, listen, and understand verbal and written communication. The ability to stoop, kneel, crouch, reach, stand, and walk. The ability to push, pull, lift, finger, and grasp. Visual acuity to perform close activities such as: reading, writing, and analyzing; operating a motor vehicle or heavy equipment, and to determine the accuracy, neatness, and thoroughness of work assigned or to make general observations. The working environment includes a variety of physical conditions including noise, inside and outside conditions including temperature changes; atmospheric conditions including odors, fumes, and dust.