Associate Director, Quality Control
Full-time
Novo Nordisk Inc.
About the Department At Novo Nordisk, we want to make a difference. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on the opportunity to help improve the quality of life for millions of people around the world. In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains. Our Product Supply Aseptic Manufacturing (PS AM) facility in Clayton, NC is a 457,000 square foot aseptic "fill and finish" site that is responsible for producing innovative, injectable diabetes and obesity treatments. At PS AM, you'll join a global network of manufacturing professionals who are passionate about what they do. What we offer you:
- Leading pay and annual performance bonus for all positions
- All employees enjoy generous paid time off including 14 paid holidays
- Health Insurance, Dental Insurance, Vision Insurance - effective day one
- Guaranteed 8% 401K contribution plus individual company match option
- Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave
- Free access to Novo Nordisk-marketed pharmaceutical products
- Tuition Assistance
- Life & Disability Insurance
- Employee Referral Awards
- Drive a safe workplace culture, ensuring safety & environmental requirements are met
- Ensure processes are capable of meeting quality specifications & requirements
- Drive alignment to annual P&O processes (Evolve, One Review, Talk-to Grow, etc.)
- Focus on eliminating defects & building simplicity into processes
- 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 & collaboration across teams/departments for alignment
- Use systems & coach employees to maximize value & minimize waste
- Provide strategic resource planning to operate processes in a cLEAN® way
- Coach, develop and engage direct reports, focusing on the NNWay essentials
- Integrate quality & business ethics into all decisions
- Coordinate with head of department& other teams on workload issues & priorities
- Frequent planning to ensure resources are in place to execute the plan, to include ensuring alignment with all budget/cost, quality and deliverables
- Ensure tracking & reporting of KPIs
- Communicate with customers and stakeholders to ensure knowledge transfer & alignment with all other relevant stakeholders
- Follow all safety and environmental requirements in the performance of duties
- Other accountabilities, as assigned
- Bachelor's Degree in science, engineering or related field of study from an accredited university required, with a minimum of seven (7) years of direct leadership/management experience in a clinical or industrial/pharmaceutical laboratory and a minimum of eight (8) years working in a manufacturing environment required, preferably a pharmaceutical manufacturing environment
- Minimum five (5) years of analytical GMP laboratory experience required
- Knowledgeable in one or more of the following areas: Microbiological or chemical testing, Laboratory Equipment, Validations/Transfers, Stability programs, GMPs, or laboratory techniques required based on assigned area
- Experience driving process improvements/design using systematic methodologies, Lean principles, Six Sigma, etc., required
- Demonstrated attention to detail, proofreading & strong computer skills with a willingness to learn new IT applications required
- Demonstrated knowledge of US & ISO regulations & guidelines, & applications of cGMP's within microbial area based on assigned area required
- Demonstrated knowledge of pharmaceutical industry validation requirements including a thorough understanding of cleaning, equipment, utility, computer & process validation requirements & concepts required
- Excellent written & oral communication skills & the ability to author scientific & technical reports required
- Organization/Planning: Proven expertise in leading execution of a process, planning/organizing, checking results & creating the cycle plan in accordance with testing needs required
- Proven expertise in mentoring & staff development, change management, planning & organizing, managing execution & revising work plans for complex issues addressed by cross functional teams required
Vacancy posted 3 days ago
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