What are the responsibilities and job description for the Manager, Quality Assurance position at BioSpace?
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.
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.