The PositionResponsible for leading the QA Support department to ensure fulfillment of departmental targets in accordance with the Novo Nordisk Way while maintaining compliance with applicable regulations & SOPs. Leads initiatives to drive process improvements within respective department.
RelationshipsReports to Vice President, Quality Assurance.
Essential Functions- Responsible for leading the QA Support department according to PS Leadership competences, including:
- Maintaining compliance with applicable regulations & procedures
- Target setting & follow-up (performance management)
- Prioritization of tasks
- Improvement of productivity through efficient processes
- Development of employees
- Effectively lead through others as a second-line leader
- Driving high performance & employee engagement
- Contributing to the site Quality Management team by participation in strategy development
- Ensuring robust processes are in place to exceed all quality objectives & requirements
- Championing Continuous Improvement processes in the team
- Promoting positive collaboration with internal & external stakeholders
- Participation in regulatory inspections & internal audits
- Backup for Vice President of Quality
- Other accountabilities, as assigned
Physical RequirementsAbility to work in an open office environment with the possibility of frequent distraction. Ability to travel up to 10% of the time. (% can change on a case-by-case basis based on the role.)
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 Life Sciences, Engineering or related field required
- Minimum of seven (7) years of leadership (direct or indirect) experience.
- Minimum of eight (8) years of experience in the pharmaceutical industry, preferably with experience in finished production processes of devices and combination products
- Demonstrated expertise & knowledge of US, EU regulations & guidelines, & application of GMP's preferred
- Demonstrated knowledge of Pharmaceutical Quality Systems (i.e. ICH Q10) preferred
- Excellent written & oral communication skills preferred
- Exercises good judgment in decision-making preferred
- CQA, CMQ/OE, &/or CQE certification preferred
- Demonstrated knowledge of cLEAN® preferred
- Proven expertise in mentoring & development, change management, planning & organizing, managing execution, & revising work plans for complex issues addressed by cross-functional teams required
