What are the responsibilities and job description for the IT Validation & Compliance Lead (Onsite) position at BioSpace?
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 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?
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 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 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. 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 ManagementFacilitate 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 CollaborationProvide 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 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 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 Novo Nordisk 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 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 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.
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.
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?
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 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 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. 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 ManagementFacilitate 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 CollaborationProvide 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 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 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 Novo Nordisk 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 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 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.
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.