IT Validation & Compliance Lead (Onsite)

Novo Nordisk; West Lebanon (NH); On-site; USD 90,000 - 120,000; Full time

Job summary

Novo Nordisk in West Lebanon, NH is seeking a Lead IT Validation & Compliance expert. This on-site role is critical for ensuring compliance of IT solutions with relevant regulations, improving product quality, patient safety, and data integrity.

The ideal candidate will have a strong background in IT compliance within the pharmaceutical sector, along with proven leadership skills. Opportunities for mentorship and professional growth are available.

Qualifications

• Minimum of seven years of experience in IT compliance, preferably within the pharmaceutical industry.
• Excellent writing and communication skills in English required.
• Lean Six Sigma certification preferred.

Responsibilities

• Provide subject matter expertise in Computer Systems Validation and IT compliance.
• Ensure IT solutions comply with regulations and standards.
• Lead project activities in IT CSV and collaborate with cross-functional teams.

Skills

IT compliance

Computer Systems Validation

Quality Systems

Project management

Communication skills

Education

Bachelor's degree in Information Technology or related field

Master's degree in Information Technology or related field

Tools

HP ALM

MS Office

Job description

About The Department

Site New Hampshire, located in West Lebanon, is where Novo Nordisk’s life‑saving treatments are brought to life. Our manufacturing facility produces a global supply of our hemophilia and growth hormone product lines, as well as our next‑generation cutting‑edge medications. It’s not your average production site – it’s a tight‑knit, supportive community working together to contribute to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a patient‑focused mindset guides everything we do. We’re looking for individuals who are self‑starters with a strong work ethic to join our team. At Novo Nordisk, you will find opportunities, resources and mentorship to grow and build your career. Are you ready to realize your potential?

The Position

The purpose of the 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 on‑site 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, 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.
  • Facilitate, review, approve and develop validation deliverables, including 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.
  • Perform Quality Systems activities including Document Management system, Change Control, Deviations, and CAPAs.
  • Write and/or revise 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 processes 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 are properly documented and released to use.
• 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.
• Lead project activities and process improvement within the areas of accountability, incorporating cLEAN tools for visual management to track service delivery performance and communicate progress to stakeholders.
• Handle deviations, ensuring they are properly documented, investigated, and resolved in a timely manner.
• Plan and implement changes in a controlled manner, documenting, assessing impact, and ensuring regulatory compliance.
• 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.
• Perform other duties as assigned, in a compliant and ethical manner, in accordance with all applicable healthcare laws, regulations, and industry codes.
• Incorporate the Novo Nordisk Way and 10 Essentials in all activities and interactions with others.

Qualifications

• Education and Certifications
  • Bachelor’s degree in Information Technology or related field from an 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.
  • Master’s degree in Information Technology or related field from an accredited college or university preferred with a minimum of five (5) years of experience in IT compliance.
  • Minimum of five (5) years of experience in Validation & Testing of IT solutions.
  • 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, preferably HP ALM.
  • Experience as an SME participating in Audits and Inspections.
  • Experience with GxP, change management and deviation handling.
  • Experience with Incident, Problem, and Change Management in IT.
  • Excellent writing and communication skills in English.
  • Excellent 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 ability to deal with complexity and ambiguity.
  • Strong computer skills and proficiency in MS Office.

Physical Requirements

0‑10% overnight travel required. This position may lift up to 33 lbs (15 kg) occasionally, and/or up to 10 lbs 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 may be required. The working environment includes a variety of physical conditions including noise, temperature changes, odors, fumes, and dust.

Equal Opportunity Statement

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, we’re not chasing quick fixes – we’re creating lasting change for long‑term health. For over 100 years, we’ve been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what’s possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we’re making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1‑855‑411‑5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.