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Associate Director, Head of Quality
Job in
Ottertail, Otter Tail County, Minnesota, 56571, USA
Listed on 2026-02-18
Listing for:
Lonza
Full Time
position Listed on 2026-02-18
Job specializations:
-
Quality Assurance - QA/QC
Data Analyst
Job Description & How to Apply Below
Quality Assurance
- Oversee QA operations, including batch release, complaint handling, and cGMP compliance.
- Represent the site during customer audits and regulatory inspections.
- Collaborate with cross-functional teams to ensure quality standards in manufacturing.
- Lead QC functions covering Raw Material, Analytical, Microbiology, Biochemistry, and Environmental Monitoring.
- Ensure timely testing and release of results, including Certificates of Analysis.
- Develop and implement QC strategies aligned with business goals.
- Implement and maintain procedures in alignment with global and national cGMP regulations.
- Translate global quality standards into site-level policies and practices.
- Maintain site readiness for audits and certifications.
- Ensure all quality related customer complaints are investigated and handled in time.
- Develop insights that can be used to enhance customer satisfaction or other metrics.
- Identify when company and customer interest may not align and seeks effective solution to resolve or escalate.
- Keep the site updated with the recent applicable regulations.
- Coordinate with all functions to ensure site compliance with the latest requirement and monitor execution of the related action plan.
- Develop long-term and annual quality plans.
- Lead quality improvement projects in line with the Operational Excellence strategy.
- Drive strategic initiatives to strengthen quality systems and processes.
- Manage department budgets, staffing, and scheduling.
- Ensure adequate resources are available to meet business and regulatory demands.
- Prioritize quality initiatives to meet critical timelines.
- Build and lead a high-performing quality team across QA, QC, and Compliance.
- Implement team development, training, and succession plans.
- Foster a compliant, efficient, and collaborative team culture.
- Degree :
Master degree, - Field of Study:
Pharmacy, Chemistry, Biotechnology, Engineering - English:
Business Fluent - Highly Experienced (10+ years) in Leading Senior Quality Function.
- People management skills
- Strong communication skills (vocal/written/presentation)
- Strong execution skills (ability to plan and take activities to closure)
- Project management skills
- Strong analytical skills
Position Requirements
10+ Years
work experience
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