SK Life Science, Inc.
Join SK Life Science, Inc. as Director of Inspection Management and Quality Compliance at our Paramus, Bergen County location. This full-time leadership role drives regulatory excellence and quality assurance strategy across the organization, directly supporting the VP and Head of Global Quality.
About the Role
You'll lead our comprehensive inspection management and quality compliance programs, overseeing a dedicated quality assurance team. This position combines strategic direction with hands-on operational leadership, ensuring the highest standards of regulatory readiness and compliance excellence throughout our organization.
What You'll Do
- Develop and execute end-to-end GCP and GVP quality assurance strategies aligned with regulatory requirements and organizational objectives
- Lead, mentor, and develop a quality assurance team committed to continuous improvement and compliance excellence
- Conduct risk-based audits and quality assessments to identify compliance gaps and drive corrective actions
- Integrate quality-by-design methodologies across production and operational processes
- Manage inspection readiness programs and oversee preparation for regulatory inspections and audits
- Establish quality risk management processes, track performance metrics, and monitor compliance indicators
- Develop and maintain standard operating procedures, quality documentation systems, and compliance records
- Partner with cross-functional departments to ensure consistent application of quality standards
What We're Looking For
- 5+ years of quality compliance and inspection management experience in life sciences or pharmaceuticals
- Demonstrated expertise in GCP (Good Manufacturing Practice) and GVP (Good Vigilance Practices) frameworks
- Proven success leading quality assurance teams and building regulatory compliance programs
- Strong knowledge of FDA regulations, ICH guidelines, and international quality standards
- Excellent leadership, communication, and analytical capabilities
- Experience managing complex compliance documentation and regulatory submissions
- Bachelor's degree in a relevant field; advanced certification or graduate degree preferred
How to Apply
Apply through this listing to join SK Life Science, Inc. in Paramus, Bergen County.
To apply for this job please visit www.adzuna.com.
Working in Paramus, Bergen County
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