Manager, Quality Assurance

About the DepartmentAt 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 positionsAll employees enjoy generous paid time off including 14 paid holidaysHealth Insurance, Dental Insurance, Vision Insurance – effective day oneGuaranteed 8% 401K contribution plus individual company match optionFamily Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leaveFree access to Novo Nordisk-marketed pharmaceutical productsTuition Assistance Life & Disability InsuranceEmployee Referral AwardsAt 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 PositionThe Manager, QA 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.RelationshipsReports to Senior Manager or above.Essential FunctionsAccountable for daily operations to maintain Quality standards and project timelines, including execution of work, coordination with stakeholders and communication with leadershipResponsible for all activities within functional areaManage resources assigned to each functional areaEnsure employee training is executed according to defined training plans and maintain current training plansIdentify, maintain and report functional KPIs to site managementMonitor and report project milestone completion and timingDrive continuous improvement through leading cross function teams to address process improvement, system improvement, new regulations/expectations, new business needs, training improvements and KPI performance improvementsMaintain safe and healthy work environment by establishing and enforcing organization standards and adhering to legal regulationsReview and approve data and reportsConduct performance reviews and engage in employee hiring processRoutinely participate in customer team meetingsAssist in customer audits and regulatory inspectionsProvide technical assistance for personnelLead team members to improve and reinforce performance of othersTake responsibility for direct reports’ performance by setting clear goals and expectations, tracking progress against the goals, ensuring constructive feedback and addressing performance-related concerns and issues promptlyWork with, coach and support direct reports in developing knowledge, skills and abilities in the interest of performance improvement and employee’s career developmentResponsible for collaboration with internal stakeholders to review results of quality assessments, maintain effective and efficient processes and ensure appropriate test directives are established and implementedSupports execution of the Quality Management System Management Systems in CGMP manufacturing and quality controlTracks and reports performance indicatorsDevelop and implement action plans to address gaps and achieve department objectivesAuthor and revise procedures and approve protocols associated with the assigned functional areaWrite, review and approve deviationEnsures employee training is executed according to defined training plans and maintains current training plansDrives continuous improvement through leading cross function teams, to address process improvement, system improvement, new regulations/expectations, new business needs, training improvements and KPI performance improvementsMaintains safe and healthy work environment by establishing and enforcing organization standards, adhering to legal regulationsOther duties as assignedPhysical Requirements100% work scheduled based on-site at Bloomington, Indiana facility. Ability to sit at a desk.Development Of PeopleSupervisory. 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.QualificationsBachelor's Degree in related field of study from an accredited university required and a minimum of four (4) years of relevant experience requiredIn lieu of Bachelor's Degree with four (4) years of experience, may consider an Associate's Degree in related field of study from an accredited college or university with a minimum of six (6) years of relevant experience requiredIn lieu of Bachelor's Degree with four (4) years of experience, may consider a High School Diploma or equivalent with a minimum of eight (8) years of relevant experience required3 years of Quality Assurance support to cGMP pharmaceutical production or other regulated industry required5 years of GMP experience or other regulated industry required1-3 years of management experience requiredSkills include competencies needed to effectively perform in the roleAdaptability and continuous learningStrong analytical and problem-solving skills with keen attention to detailExcellent 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 environmentDesire to coachWe 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 View phone number on click.appcast.io. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.