Associate Director, Quality Control
On-site · Clayton, North Carolina, United States
Job Summary
Lead strategic activities to drive line performance, process improvements & technical improvements within the assigned department. Ensure fulfillment of departmental targets in accordance with the Novo Nordisk Way while maintaining compliance with applicable regulations & SOPs. Manage all activities & personnel related to the establishment & operation of the laboratories supporting analysis of materials & products for the associated stakeholders. Drive a safe workplace culture, ensure processes are capable of meeting quality specifications & requirements, align process activities with lead time targets, set direction by developing transparent process objectives based on site goals, drive process performance to meet business & customer needs, drive operations standardization, equipment maintenance & compliance, coach employees to maximize value & minimize waste, provide strategic resource planning to operate processes in a cLEAN® way, coach, develop and engage direct reports, integrate quality & business ethics into all decisions, coordinate with head of department & other teams on workload issues & priorities, ensure KPIs are tracked & reported, communicate with customers and stakeholders to ensure knowledge transfer & alignment with all other relevant stakeholders, follow all safety and environmental requirements, contribute to ongoing improvements and development of staff and processes.
Required Qualifications
- Bachelor's Degree in science, engineering or related field of study from an accredited university
- minimum seven (7) years of direct leadership/management experience in a clinical or industrial/pharmaceutical laboratory
- minimum of eight (8) years working in a manufacturing environment, preferably a pharmaceutical manufacturing environment
- minimum five (5) years of analytical GMP laboratory experience
- Knowledgeable in Microbiological or chemical testing, Laboratory Equipment, Validations/Transfers, Stability programs, GMPs, or laboratory techniques
- Experience driving process improvements/design using systematic methodologies, Lean principles, Six Sigma, etc.
- Excellent written & oral communication skills & the ability to author scientific & technical reports
- Organization/Planning: Proven expertise in leading execution of a process, planning/organizing, checking results & creating the cycle plan in accordance with testing needs
- Proven expertise in mentoring & staff development, change management, planning & organizing, managing execution & revising work plans for complex issues addressed by cross functional teams
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