Manager, Quality Assurance

BioSpace; Bloomington (IN); On-site; USD 120,000 - 150,000; Full time

Benefits offered by this job

Annual bonus

Paid time off

Health insurance—day one

401K with match

Parental & family leave

Product access

Tuition assistance

Life & disability insurance

Referral awards

Job summary

Nova Nordisk's Bloomington, Indiana site seeks a Manager, QA to ensure compliance with FDA and internal quality systems. The role includes systems implementation, documentation management, audits, and material disposition to deliver high-quality drug products.

The position reports to Senior Manager or above and leads a team, driving improvements, training and KPI reporting while ensuring a safe work environment and regulatory adherence.

Qualifications

• Bachelor's degree in a related field is required, with 4+ years of relevant experience.
• 3 years of Quality Assurance support to cGMP pharmaceutical production or other regulated industry.
• 5 years of GMP experience or other regulated industry experience.
• Strong analytical and problem-solving skills with keen attention to detail.

Responsibilities

• Accountable for daily operations to maintain Quality standards and project timelines.
• Identify, maintain and report functional KPIs to site management.
• Lead cross-functional teams to address process improvements and KPI performance.
• Review and approve data and reports; write and approve deviations.
• Coach and develop reporting personnel, ensuring progress against goals.

Skills

Analytical skills

Problem solving

Communication skills

Organizational skills

Coaching/mentorship

Adaptability

Education

Bachelor's Degree in related field

Associate's Degree with 6+ years experience

High School Diploma with 8+ years experience

Job description

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.

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 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.

Relationships

Reports to Senior Manager or above.

Essential Functions

• Accountable for daily operations to maintain Quality standards and project timelines, including execution of work, coordination with stakeholders and communication with leadership
• Responsible for all activities within functional area
• Manage resources assigned to each functional area
• Ensure employee training is executed according to defined training plans and maintain current training plans
• Identify, maintain and report functional KPIs to site management
• Monitor and report project milestone completion and timing
• Drive continuous improvement through leading cross function teams to address process improvement, system improvement, new regulations/expectations, new business needs, training improvements and KPI performance improvements
• Maintain safe and healthy work environment by establishing and enforcing organization standards and adhering to legal regulations
• Review and approve data and reports
• Conduct performance reviews and engage in employee hiring process
• Routinely participate in customer team meetings
• Assist in customer audits and regulatory inspections
• Provide technical assistance for personnel
• Lead team members to improve and reinforce performance of others
• Take 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 promptly
• Work with, coach and support direct reports in developing knowledge, skills and abilities in the interest of performance improvement and employee’s career development
• Responsible for collaboration with internal stakeholders to review results of quality assessments, maintain effective and efficient processes and ensure appropriate test directives are established and implemented
• Supports execution of the Quality Management System Management Systems in CGMP manufacturing and quality control
• Tracks and reports performance indicators
• Develop and implement action plans to address gaps and achieve department objectives
• Author and revise procedures and approve protocols associated with the assigned functional area
• Write, review and approve deviation
• Ensures employee training is executed according to defined training plans and maintains current training plans
• Drives continuous improvement through leading cross function teams, to address process improvement, system improvement, new regulations/expectations, new business needs, training improvements and KPI performance improvements
• Maintains safe and healthy work environment by establishing and enforcing organization standards, adhering to legal regulations
• 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

• Bachelor's Degree in related field of study from an accredited university required and a minimum of four (4) years of relevant experience required
• In 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 required
• In 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 required
• 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'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 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.