Quality Systems Manager

Evergen; Northern (KY); Híbrido; USD 115.000 - 135.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

PTO

401(k) with match

Holiday pay

Medical, dental, vision insurance

Disability coverage

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Communication

QMS software

MS Office

Process improvement

Data analysis

Statistics

Educación

Bachelor’s degree in life sciences

Descripción del empleo

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Quality Systems Manager

Full-Time Management Alachua, FL, US

Salary Range: $115,000.00 To $135,000.00 Annually

Location: Alachua, FL

Annual CIP bonus opportunity of up to $15,000.00

Evergen is a global industry-leading contract development and manufacturing organization (CDMO) in regenerative medicine. As the only regenerative medicine company that offers a differentiated portfolio of allograft and xenograft biomaterials at scale, Evergen is headquartered in Alachua, FL, and has manufacturing facilities in West Lafayette, IN; Eden Prairie and Glencoe, MN; Neunkirchen, Germany; Glasgow, UK; and Marton, New Zealand.

We are proud to be Great Place to Work® Certified in 2026, reflecting our commitment to creating an exceptional employee experience and workplace culture. Evergen currently has full-time career opportunities available across multiple locations.

• Paid Time Off (PTO)
• 401(k) with up to a 6% company match
• Holiday pay
• Medical, dental, and vision insurance
• Short-term and long-term disability coverage
• 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;
  • Maintenance of quality and regulatory registrations, licenses, accreditations, and certifications, including notifications;
  • Document Management and Record Control;
  • Non-conformance (NC) and Corrective Action/Preventive Action (CA/PA);
• Change Management
• Collects, analyzes, and reports data elements to demonstrate conformity and maintain effectiveness of the quality management system
• Supports and provides guidance to stakeholders in execution of NC, CA/PA, and audit response actions
• Manages staff members in leading and participating in third-party audits including Notified Body inspections, leads cross-functional teams to support the development of responses, and tracks response commitments within the CA/PA system
• Develops and implements process improvement initiatives within Quality Systems programs to increase efficiency and reduce complexity
• Supports company process improvement initiatives that impact Quality Systems and works collaboratively with cross-functional stakeholders to ensure compliance of processes and procedures within the quality management system
• Reviews and approves quality system documentation for accuracy, consistency and compliance
• Leads the Quality System team by recruiting, onboarding, training, developing career growth opportunities, and giving effective performance feedback
• Other duties as assigned

REQUIREMENTS:

Education

• Bachelor’s degree in a life sciences discipline or related field

Experience

• 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
• Additional experience may be considered in lieu of education requirement

Certification

• AATB Certified Tissue Bank Specialist (CTBS), preferred
• Process Improvement Methodology certification, preferred

Skills

• Excellent verbal and written communication
• Quality Management System (QMS) software
• Microsoft Office Suite, advanced Excel
• Process Improvement Methodologies
• Sampling Plans and Statistical techniques
• Data Analysis

Travel

• Minimal travel required, may occasionally travel for professional development or to support company initiatives, such as for audit support

Safety:

Physical Requirement

• Move or lift objects up to 25 pounds
• Frequent (>75%) stationary position (standing or sitting) while utilizing digital displays
• Frequent (>75% fine manipulation using hands and fingers (typing, opening, writing, clicking, paper sorting, etc.)
• Onsite: Office environment with assigned workstation
• Remote positions only: Home office environment with minimum distractions

More about Evergen:

Evergen provides customers across a diverse set of market segments with leading-edge expertise, scale, and flexibility across end-to-end services including design, development, regulatory support, verification and validation, manufacturing, and supply chain management.

Evergen is rooted in a steadfast commitment to quality, integrity, and patient safety with a focus on five key values:

• Accountable: We own our actions and decisions.
• Agile: We embrace change to stay ahead of the curve and evolve to drive innovation and growth.
• Growth Mindset: We embrace challenges as opportunities for continuous learning.
• Customer-Centric: We prioritize customers at every touch point.
• Inclusive: We thrive on the richness of our diversity and ensure every voice is heard, respected, and celebrated.

At Evergen, we are committed to fostering an inclusive workplace where we embrace the richness of our diversity and ensure that every voice is heard, respected, and celebrated. We believe that by embracing diversity and promoting inclusivity, we not only uphold our values but also strengthen our position as the CDMO of Choice in regenerative medicine solutions. We recognize that cultivating a growth mindset is essential to our success, and we are dedicated to continuous learning and improvement in our diversity, equity, and inclusion efforts. Through accountability and action, we strive to create an environment where individuals can thrive, innovate, and contribute their unique perspectives to drive our collective success.

Montagu Private Equity (“Montagu”), a leading European private equity firm, acquired Evergen in 2020 and has supported the transformation of the company to its next level of potential.