IT Validation & Compliance Lead (Onsite)

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., Computer Systems Validation ExpertInvolved 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 WarehousingEnsure that IT solutions are compliant with relevant regulations and standards, e.g. 21 CFR Parts 11, EU Annex 11, and GAMP requirements among othersFacilitate, 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 InstructionConduct risk assessments and impact analyses to identify potential compliance issues and develop mitigation strategiesProvide guidance and support to project teams on validation and qualification requirementsContinuously monitor and improve documentation and processes to ensure compliance with regulatory requirements and Novo Nordisk 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 CSVPerform assigned Quality Systems activities including Document Management system, Change Control, Deviations, and CAPA’sWriting and/or revising procedures applicable to CSV activitiesWork in collaboration with the Engineering group to prepare the validation, requalification, and maintenance program

CSV Service Delivery ManagementFacilitate the seamless transition and handover of projects to service operations with key stakeholdersMaintain system documentation and process according to Novo Nordisk standards and in compliance with regulatory requirementsParticipate as an CSV SME in audits and inspections and provide needed documentation to demonstrate validated state and release to useCollaborate with cross-functional teams to ensure that all IT solutions are properly documented and released to useEnsure that all documentation and processes are following regulatory requirements and Novo Nordisk standardsLeadership and CollaborationProvide leadership and expertise in IT CSV, process improvement, and project coordinationCollaborate with cross-functional teams to ensure that IT solutions meet business needs and are delivered on time and within budgetCoach and mentor personnel, and provide guidance as neededParticipate in process group meetings and contribute to process group activitiesEnsure that all activities are aligned with Novo Nordisk Way Essentials and support the organization’s mission to improve the lives of people with chronic diseasesThe 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 initiativesResponsible 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 Novo Nordisk standards. Moreover, will also perform other duties as assigned Other duties as assignedPerforms all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations and industry codesIncorporates the Novo Nordisk Way and 10 Essentials in all activities and interactions with others

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 of 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?, 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, requiredMaster’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, requiredMinimum of five (5) years of experience in Validation & Testing of IT solutions, requiredCOBIT Certification is preferredLean Six Sigma Green Belt or Black Belt is preferredExperience with electronic application lifecycle software, from requirements gathering to testing and deployment, preferrable HP ALM, requiredExperience as SME participating in Audits and Inspections, requiredExperience on GxP, change management and deviation handling, requiredExperience with Incident, Problem, and Change Management in IT, requiredExcellent writing and communication skills, in English, requiredExcellent customer service skills and ability to collaborate effectively in a team environment, requiredExcellent problem solving, negotiation, conflict management, and interpersonal skills, requiredExcellent planning, organizing, decision making and deal with complexity and ambiguity, requiredStrong 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.

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 a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat diabetes and other serious chronic diseases such as obesity and rare blood and endocrine disorders. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 54,400 people in 80 countries and markets its products in around 170 countries. For more information visit novonordisk.com.

Our US Research & Development hub, located in the Greater Boston area, brings together the best talent to drive life science innovation. Located in Lexington, Watertown and Cambridge, our teams reflect the full scope of R&D, from early research through late-stage clinical development. We are building for the future by creating a distinct R&D community based on collaboration, partnerships, and cutting-edge research across multiple modalities and therapeutic areas. We recognize that improving human health starts here and that patients rely on us. By combining the speed and agility of biotech with the quality, resources, and stability of a large pharmaceutical company, our US R&D hub will benefit from the best of both worlds to develop new medicines that meet the needs of patients.