Senior Quality Systems Manager - Regenerative Medicine

Evergen; Northern (KY); Hybrid; USD 115,000 - 135,000; Full time

Benefits offered by this job

PTO

401(k) with match

Holiday pay

Medical, dental, vision insurance

Disability coverage

Job summary

Evergen is a global CDMO focused on regenerative medicine, headquartered in Alachua, FL, with sites worldwide. The Quality Systems Manager will lead the quality program, ensuring compliance with FDA/ISO requirements and directing audit activities across multiple facilities.

The role requires 5+ years in quality/regulatory affairs and 3+ years of leadership, with strong data analysis, process improvement, and cross-functional collaboration skills. AATB CTBS is preferred and travel is minimal.

Qualifications

• Bachelor’s degree in a life sciences discipline or related field.
• 5+ years of experience in a Quality or Regulatory Affairs.
• 3+ years of leadership experience.
• 0-3 years of experience managing quality systems that require compliance with FDA Part 1271, FDA Part 820, ISO 13485 or AATB Standards.
• AATB Certified Tissue Bank Specialist (CTBS) preferred; Process Improvement Methodology certification preferred.

Responsibilities

• Oversees critical Quality Systems programs to ensure compliance with applicable regulations, standards and company objectives including: Complaint Handling and Post-Market Surveillance activities.
• Internal and third-party audits; Notified Body inspections and responses.
• Maintenance of quality registrations, licenses, accreditations, and certifications, including notifications.
• Document Management and Record Control.
• Non-conformance and Corrective Action/Preventive Action (CA/PA) processes.
• Leads cross-functional teams to support audit responses and CAPA actions.
• Develops and implements process improvement initiatives within Quality Systems.
• Supports and ensures compliance of processes and procedures within the quality management system.
• Reviews and approves quality system documentation for accuracy and consistency.
• Leads the Quality System team through recruiting, onboarding, training, and performance feedback.

Skills

Communication

QMS software

MS Office

Process improvement

Data analysis

Statistics

Education

Bachelor’s degree in life sciences

Job description

Evergen is a global CDMO focused on regenerative medicine, headquartered in Alachua, FL, with sites worldwide. The Quality Systems Manager will lead the quality program, ensuring compliance with FDA/ISO requirements and directing audit activities across multiple facilities.

The role requires 5+ years in quality/regulatory affairs and 3+ years of leadership, with strong data analysis, process improvement, and cross-functional collaboration skills. AATB CTBS is preferred and travel is minimal.