Quality Systems and Compliance Manager
Overview
Lead a team of five Quality Assurance professionals to drive quality and compliance initiatives across the organization. Own QMS processes ensure regulatory compliance and audit readiness. Foster continuous improvement and manage audit findings. Close quality events while maintaining compliance. Drive performance management and employee development. Partner with HR on staffing and leadership development. Differentiate by scaling quality systems and leveraging expertise.
What You'll Do11
- 1Provide leadership oversight for site quality activities and audit management
- 2Lead quality investigations and root cause analysis with 20% completion target
- 3Train and develop direct reports to maintain competency standards
- 4Drive continuous improvement initiatives for product quality and compliance
- 5Conduct performance management activities including coaching and evaluations
- 6Partner with HR on employee relations and staffing matters
- 7Maintain and enhance Quality Management System processes
- 8Ensure adherence to cGMP regulations and FDA requirements
- 9Manage internal, customer, and regulatory audits with 50% response responsibility
- 10Develop quality system effectiveness through operational efficiency improvements
- 11Implement compliance training programs for all team members
Requirements10
- 1Bachelor's degree in Biology Chemistry Pharmaceutical Sciences Engineering or related field
- 2Minimum 5 years experience in cGMP-regulated manufacturing environments
- 3Proven experience leading internal customer and regulatory audits
- 4Strong knowledge of FDA requirements and quality system standards
- 5Experience managing Quality Assurance and Quality Management Systems
- 6Demonstrated ability to foster continuous improvement culture
- 7Skilled in performance evaluation and development planning
- 8Expertise in compliance training program implementation
- 9Background in pharmaceutical or regulated industry operations
- 10Ability to work effectively in collaborative team settings
Salary Insight
Salary not disclosed in listing
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