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 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: + Leading pay and annual performance bonus for all positions + All employees enjoy generous paid time off including 14 paid holidays + Health Insurance, Dental Insurance, Vision Insurance – effective day one + Guaranteed 8% 401K contribution plus individual company match option + Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave + Free access to Novo Nordisk-marketed pharmaceutical products + Tuition Assistance + Life & Disability Insurance + 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 Principal Representative - Quality Management Systems is responsible for leading and supporting Quality Risk Management (QRM) activities for products such as combination, pharmaceutical and medical devices. This role will ensure business objectives are met to support and sustain the Quality System in compliance to Quality Risk Management regulations, guidance’s and standards. Relationships Reports to Senior Manager Essential Functions + Areas of direct responsibility include development and maintenance of QA procedures for risk management that support business objectives, functional area strategies, and the overall Quality System + Analyzes data to identify trends and assess performance on risk mitigation efforts. Develop reports and presentations for stakeholders on risk assessments and mitigation activities + Effectively communicates risk information and recommendations to relevant stakeholders within the organization. Monitors and reports on the effectiveness of risk management controls + Develops and maintains the site quality risk register and all related documentation + Responsible for facilitating Risk Management Quality Review Board and publishing meeting minutes + Identifies opportunities to improve processes and workflows to enhance quality and reduce risks + Trains and educates employees who participate in risk review activities to learn the risk management assessment process, risk management principles and best practice + Maintains and enhances effectiveness of the Quality System, including developing and reporting metrics, identification, and implementation of improvement opportunities for established Quality Systems, processes, procedures + Support Client and Regulatory inspections + Drives alignment and improvement initiatives, leading cross function teams, to address process improvement, system improvement, and new regulations/expectations + Maintains a sufficient understanding of the quality systems and operations + Assist with revision of GMP documentation such as Standard Operating Procedures + Promotes teamwork, a positive work environment and an atmosphere that enhances continuous improvement in aseptic quality and production environment + Demonstrate and promote a "Right the First Time" culture, while operating in a safe manner, elevating all safety issues and concerns appropriately and in a timely manner + Follow all SOPs, cGMPs, and remain current with all training requirements + Notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance + Other duties as assigned Physical Requirements 100% onsite at the Bloomington, Indiana site Qualifications + Bachelor's degree from an accredited university with a mininum of eight (8) years of relevant experience: Bachelor’s degree in a STEM related field, preferred + In lieu of a Bachelor’s degree with a minimum of two (2) years of experience, may consider an Associate’s Degree from an accredited university with a minimum of ten (10) years of relevant experience required; Associate’s degree in a STEM related field, preferred + In lieu of a Bachelor’s degree with a minimum of two (2) years of experience, may consider a High School Diploma with a minimum of twelve (12) years of relevant experience, required + Min of 4 years GxP experience or other regulated industry + Excellent written and verbal communication skills with the ability to share vision, direction, and data with colleagues across all levels and in a wide range of different work groups including senior leadership and regulatory agencies + Strong analytical and problem-solving abilities. Capable of making decisions using experience along with site process and procedures + Robust interpersonal skills, organizational skills, and project management skills, with the ability to balance multiple priorities and projects + Must be able to read and understand English-written job instructions and safety requirements + Prior experience working in and/or supporting aseptic operations in a cGMP environment as it relates to cleaning and sanitization, regulatory (worldwide), deviation investigation, product and process validation, environmental testing, and investigations, preferred + A strong working knowledge of quality systems and processes, preferred + Technical Requirements + Ability to use Excel, Word, and other office systems + Ability to learn and use quality management software such as TrackWise® or ComplianceWire® + Ability to understand and independently apply CGMPs to everyday work + Demonstrates understanding of the work tasks assigned + Executes procedures of moderate complexity with high quality + Intermediate understanding of pharmaceutical laboratory and/or production operations + Capable of learning unfamiliar principles or techniques with training + Ability to contribute to investigations, deviations, and change controls with initial consultation from supervisor + Ability to problem solve and execute and monitor corrective actions + Ability to interpret data and analyze trends and provide insight into potential issues and suggest solutions + Edits Standard Operating Procedures (SOPs) and reports with guidance from supervisor + Seeks best practices for daily work activities + Behavioral Requirements + Ability to see and hear and read and write clear English + Ability to communicate effectively and follow/retain detailed written and verbal instruction in an accurate, timely, safe, and professional manner with supervisor, group members, and other departments as necessary, in a professional and accurate manner + Ability to manage time effectively to complete assignments in expected time frame and independently seek out additional work when tasks are completed ahead of time + Ability to cooperate with coworkers within an organized team environment or work alone We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. We’re not your typical healthcare company. In a modern world of quick fixes, we focus on solutions to defeat serious chronic diseases and promote long-term health. Our unordinary mindset is at the heart of everything we do. We seek out new ideas and put people first as we push the boundaries of science, make healthcare more accessible, and treat, prevent, and even cure diseases that affect millions of lives. Because it takes an unordinary approach to drive real, lasting change in health. 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.