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 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

Supports & manages site training & technical writing teams & relevant processes. Ensures alignment of training processes to corporate & quality systems. Responsible for maintaining Standard Operational Procedures (SOPs) for the site. Coordinate with API on alignment of SOPs & use of standards. Works closely with site stakeholders on training and document needs.

This is an onsite based role Monday-Friday at our West Lebanon, NH bioproduction facility.

Relationships

Reports to: according to the organizational chart.

Essential Functions

• People development
  • Hire, train, develop, mentor and coach team members
  • Align individual performance expectations with organizational goals
  • Develop performance goals collaboratively with direct reports
  • Ensure that performance goals are clearly communicated and current
  • Provide constructive and timely feedback towards performance expectations and goals
• Lead site training program
  • Develop, coach, and build competencies of the Training team
  • In conjunction with the training partners define the strategy for translation of corporate training initiatives (i.e., Training for Competence)
  • Drive implementation of Training for Competence and training compliance at site
  • Ensure local system and process is in place to ensure adequate training for all and to align with corporate procedures
  • Work with management & package owners to drive the establishment of facility SOP landscape
  • Coach and support the use of shop floor management tools (i.e., problem solving, process mapping, value stream mapping and process confirmation)
  • Identify, plan, implement identified improvement initiatives and ensure they are deployed in a sustainable manner
  • Act as a conduit for sharing of best practices to/from other M2-US or NN teams

• Lead document control process across site
  • Design & own process for implementation of new/revised documents (to include change control, document creation, assessment of training/documentation & routing/approval process)
  • Improve local change process for revision of documents, with focus on compliance and ease of use for document owners, users & quality approvers
  • Collaborates cross-functionally with other departments & maintains stakeholder relationships
  • Supports authors in the writing process with language usage, document control process & related tools
  • Fulfills a key role in the SOP Expert Network, Process Workshops, & other document governance groups
  • Provides specialist knowledge on the writing process to ease understanding, choice of document type, structure & language usage of the operational documents
  • Manage daily activities of the technical writing team and training team, including but not limited to staff selection, process confirmation, setting expectations & employee development
• Provide training & coaching to ensure team & stakeholders possess the required skills to work efficiently & produce SOPs that comply with the standard
• Site leader in the implementation & continuous improvement of learning & knowledge systems processes
• Ensure that all activities comply with company and or regulatory procedures, practices and guidelines
• Follow all safety & environmental requirements in performance of duties
• Other duties as assigned

Physical Requirements

Ability to work in an open office environment with the possibility of frequent distraction. Ability to travel up to 10% of the time. (% can change on a case-by-case basis based on the role.)

Development of People

Supervisory. Ensure that reporting personnel have individual development plans (IDP), with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process. Ensure that the IDP forms include completed learning and aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility. Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way.

Qualifications

• Education and Certifications
  • Bachelor’s degree in Engineering, Business, Communications, or a relevant field of study from an accredited university or an equivalent combination of education & experience required
  • M.S. preferred
• Work Experience
  • Bachelor’s degree in Engineering, Business, Communications, or a relevant field of study from an accredited university with a minimum of eight (8) years of experience supporting cGMP pharmaceutical manufacturing or an equivalent combination of education & experience required
  • Master’s degree in Engineering, Business, Communications, or a relevant field of study from an accredited university with a minimum of six (6) years of experience supporting cGMP pharmaceutical manufacturing preferred
  • Minimum of four (4) years of leadership &/or direct management responsibility experience required
  • Extensive knowledge in training principles, knowledge management, and instructional systems design preferred
  • Knowledge of pharmaceutical manufacturing quality system, including knowledge of FDA requirements preferred
  • Strong project management capabilities to guide the creation of high-quality SOPs aligned with project milestones and deliverables, coupled with a solid understanding of manufacturing operations to evaluate present and future requirements preferred
  • Proven communication skills, including written, verbal, & presentation as well as computer literacy, experience with Microsoft Office Suite & the ability to use &/or update relational databases required
  • Knowledgeable in GMP processes, Quality Management System (QMS), & standard improvement systems preferred
  • Demonstrated expertise in leading process performance enhancements and effectively organizing information through the strategic application of technology preferred
  • Demonstrated ability to apply appropriate attention to detail and managing complex processes & diverse teams preferred

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

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

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.

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