The Position

This position has the responsibility for managing and overseeing the planning, implementation, maintenance and execution of support processes related to utilities (both clean and black utilities), maintenance, and metrology. This includes equipment support, process support and GMP-related activities. This covers support for utilities in both upstream and downstream production areas, and in both our manufacturing suites for production of medicine for hemophilia and growth hormone disorders. Prior experience in a GMP and FDA manufacturing environment is a plus.

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

Relationships

Number of direct reports: Approx. 8-10 direct reports.

Reports to: Associate Director, Production Support

Essential Functions

• People development
• Hire, train, develop and coach team members to enable project execution at site
• Align individual performance expectations with organizational goals
• Develop performance goals collaboratively with direct reports
• Ensure that performance goals are clearly communicated and align with organizational goals
• Provide constructive and timely feedback towards performance expectations and goals
• Ensure compliance with EH&S policies and regulations. Promotes a safe and compliant work environment
• Lead, coach, and develop team members to be engaged and informed individual contributors. Recommend and encourage continuous training and development in individual skills
• Using the 5 principles of Human Performance and lean leadership, drive a culture of HuP and cLean (Continuous Improvement). Work to identify opportunities to increase speed/efficiencies, develop and improve standards, robustness and flow, and to reduce waste (costs), process variation and error
• Work with relevant groups towards reducing/eliminating environmental impact in all process operations and department functions
• Support maintenance and good housekeeping of machinery, equipment, and facilities in accordance with current Good Manufacturing Practices, QMR and global regulations
• Support the evaluation, specification, installation, and validation of new, repaired or redesigned utilities/metrology equipment as required
• Ensure the validated state is maintained for utilities/metrology systems as well as Supply Chain/QC-owned controlled temperature units, including warehouses
• Perform internal audits on quality systems. Perform periodic inspections of the manufacturing areas to ensure adherence to procedures and departmental and divisional standards
• Provide input, support and present during regulatory inspections
• Provide oversight, guidance, and timely and accurate closure for utilities and metrology CRs, deviations, investigations and audit findings
• Manage annual expense budgets
• Support activities in other departments as requested
• Assures all activities comply with established company policies and perform all duties in compliance with global regulatory requirements, the NNUSBPI Quality Manual and SOPs
• 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 other

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:
  • Associates degree or equivalent experience
• Work Experience:
  • 7+ years total work experience in operations, maintenance, metrology or engineering environment
  • 2+ years' experience in a management role (matrix or direct)
  • cGMP/regulated pharmaceutical or biotechnology industry experience preferred
• Knowledge, Skills, and Abilities:
  • Knowledge of working in the pharmaceutical/biotech industry under global regulatory requirements
  • Must possess strong organizational, interpersonal, oral, and written skills
  • A successful record of managing personnel and projects is required
  • Ability to lead and work in teams is required
  • Must be able to focus and influence different groups, and the ability to inspire and align commitment toward a common goal

Physical Requirements

Travel up to 10% of the time including domestic and international. The ability to stoop, kneel, crouch, reach, stand, and walk. The ability to grasp and finger. The ability to speak, listen, and understand verbal and written communication. Repetition including substantial movement of wrists, hands, and or fingers. While performing this job employee work involves sitting most of the time with walking and standing required only occasionally. Lifting to 10 pounds of force occasionally. Visual acuity to perform close activities such as: reading, writing, and analyzing; 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, working in narrow aisles, and temperature changes; atmospheric conditions including odors, fumes, and dust. Local and International Travel: 0-20%.