Senior Supervisor, QA Training Systems

About the Department

At Novo Nordisk, we want to make a difference. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world.

Our Bloomington, Indiana site is a state-of-the-art facility where we have an integrated model from process and formulation to clinical and commercial biomanufacturing and drug product fill/finish and packaging. The Bloomington campus is a recognized facility where talented teams work with innovators to help develop, manufacture and supply products to patients around the world.  

What we offer you:

1. Leading pay and annual performance bonus for all positions
2. All employees enjoy generous paid time off including 14 paid holidays
3. Health Insurance, Dental Insurance, Vision Insurance – effective day one
4. Guaranteed 8% 401K contribution plus individual company match option
5. Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave
6. Free access to Novo Nordisk-marketed pharmaceutical products
7. Tuition Assistance 
8. Life & Disability Insurance
9. Employee Referral Awards

At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career.  Are you ready to realize your potential?  Join Team Novo Nordisk and help us make what matters.

The Position

The Senior Supervisor, QA Training Systems, primary function is to ensure compliance with FDA and other regulatory agency requirements as well as internal quality systems requirements. This includes systems implementation and maintenance, documentation management, site-wide systems training, internal and external auditing, project review for accuracy and compliance, and material disposition. Quality Assurance safeguards all systems, processes, and actions to ensure regulatory compliance, which is essential in providing high-quality drug products for our clients and their patients. 

Relationships

Reports to Manager.

Essential Functions

• Leads team responsible for oversight and administrative support of the site Learning Management System and instructional designers that develop eLearning and other training content.
• Collaborate with business units and stakeholders to identify and incorporate all learning, enrollment, and reporting requirements into the LMS using consistent standards.
• Set up and maintain training items, curriculums, and user groups based on feedback and approval from area management.
• Update and assign LMS course items to align with EDMS document revision approvals.
• Initiate and drive completion and documentation of site curricula review to ensure curricula and employee assignments are reviewed by area management.
• Create, maintain, and distribute LMS reports.  Provide management with metrics and updates to assist in managing compliance with all set training objectives and requirements.
• Leads Training System projects including the development and maintenance of site LMS system standards, policies, procedures, and operations manuals.
• Reviews site SOPs for Training impact in the EDMS to ensure appropriate training methodology is applied for document revisions.
• Develops instructional content ensuring training content meets LMS and SCORM requirements.
• Provides input and/or develops training materials that support the training system and/or other GMP related training.
• Provide support during internal and external audits related to Client, regulatory, pre-inspection approval, and corporate compliance.
• Owns and completes assigned Training System actions in Trackwise related to investigations and/or internal and external inspections.
• Collects, documents, and incorporates survey feedback from training programs.
• Assess the impact of training programs on employee performance and organizational goals.  Implement metrics to measure the effectiveness of training and identify areas for improvement.
• Identifies trends and opportunities for continuous improvement of the training system.
• Other duties as assigned.

Physical Requirements

• 100% work scheduled based on-site at Bloomington, Indiana facility.
• Ability to sit at a desk

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

• High School diploma or GED, required;Bachelor’s degree in STEM, preferred.
• 3 years of Quality Assurance support to cGMP pharmaceutical production or other regulated industry required.
• 5 years of GMP experience or other regulated industry, required.
• 1-3 years of management experience, required.
• Skills include competencies needed to effectively perform in the role.
  • Adaptability and continuous learning.
  • Strong analytical and problem-solving skills with keen attention to detail.
  • Excellent communication skills, with the ability to work cross-functionally with various teams.
  • Strong organizational skills and the ability to handle multiple tasks and deadlines in a fast-paced environment.
  • Desire to coach.

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.