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 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 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.
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
