Director Project QA Novo Nordisk Clayton

Job Description
Purpose
Establishment of Quality Assurance function
Direct and coordinate the activities of the Quality organization to support the project progress.
Meet or exceed business, regulatory, and customer requirements in accordance with the Novo Nordisk Way.
Formulate, communicate and implement QA strategy that effectively supports the manufacturing of API products

Stakeholder management within project and externally to NNPII, NP US, External vendors
Coordination with Project SLT, Communications and other relevant stakeholders to ensure strong project communication
Work with relevant members of SLT to ensure aligned priorities on short/medium/long range
Maintain close working relations with EHS

Accountabilities

Technical training and development within Quality Management
Performance reviews and developmental planning
Recruitment/selection
Financial responsibility
Continuous process improvement via cLEAN
Organizational planning and objective setting
Participate as member of Site Leadership Team in setting plant goals, objectives and policies
Follow all safety and environmental requirements in the performance of duties
Policy development within own area
Quality and environmental management
Other accountabilities as assigned

Technical Competencies

Education:
MS/Ph.D. within science, engineering, or business is preferred
Minimum 10 yr. leadership/management/supervisory experience in manufacturing, maintenance, or process with a preference toward pharmaceutical or other regulated industries
Knowledgeable in systems within pharmaceutical industries to include parenteral drug production.
Proven expertise in mentoring/development, change management, planning/organizing, managing execution, and revising the work plan for complex problems solved by cross functional teams

Behavioral Competencies

Builds strong working relationships, able to lead individual crews with daily activities, strong in stakeholder management, empowerment is key
Actively participates in process/team activities, supports ideas/actions of others, uses appreciative feedback style to coach others in how to "Make their idea even better"
Quickly flexes to changes in roles and responsibilities, environments and business needs with grace and ease.
Demonstrates behaviors consistent with "For me to win the Team must win" beliefs.
Demonstrate appreciative feedback style.
Understands who the customer (internal/external) is, understands the customers' requirements, and understands the processes that generate products/services that meet the customers' requirements.
Demonstrates a disciplined approach to problem solving that is based on data and facts and is consistent with Vision/Project Goals and Values
Owns the results of their individual actions, owns the results of their Team's Activities.

Physical Requirements

Requires ability to move throughout the facility in the performance of duties in proximity of process equipment and areas

Other Requirements

Ability to work hours necessary and according to customer needs

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