The PositionThe Associate Vice President of Drug Product Manufacturing US Quality (DPM US Quality) will head up the Quality Assurance organization across the DPM Manufacturing sites in Bloomington Clayton and Site Durham. Direct and coordinate the activities of the DPM US Quality organization to support the production of Novo's products and devices through testing and quality assurance programs which meet or exceed business, regulatory and customer requirements in accordance with the Novo Way. Formulate, communicate and implement the corporate strategy that effectively supports the manufacture of Novo products through testing and quality assurance programs that ensure patient safety.
Relationships
The position reports to the Senior Vice President of Manufacturing Quality and is a member of the Manufacturing Quality Management team. The incumbent will be responsible for the entire organisation consisting of 5 direct reports and a total of 300 + employees.
In addition, the Associate Vice President will be a part of the DPM USManagement team.
Essential Functions- Head up DPM US Quality ensuring that the organization is a strong partner to Line of Business
- Formulate, communicate and implement the corporate and local strategies that effectively supports the manufacturing of Novo products to ensure patient safety Direct and manage quality management team which includes but is not limited to the following:
- Training and development
- Performance leadershipRecruitment/ selection
- Employee relations
- Budget
- Continuous process improvement via cLEAN methodologies
- Organizational planning and objective setting
- Policy development follows all safety and environmental requirements in the performance of duties
- Perform other duties 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's policies, procedures and Novo Way.
Qualifications- Bachelor's Degree in science, engineering, business, or related field of study from an accredited university required and a minimum of ten (10) years of experience in pharmaceutical quality, manufacturing or a related area required
- Master's Degree preferred
- Minimum of five (5) years of supervisory/management experience in pharmaceutical industry required
- Excellent written and verbal communication skills required
- Strong presentation skills required
- Excellent working knowledge of FDA regulations relevant to the business required
