Quality Systems Lead - Regenerative Medicine

Evergen; Alachua (FL); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

PTO

401(k) with company match

Holiday pay

Medical, dental, vision insurance

Disability coverage (short & long-term

Parental leave

Job summary

Evergen, headquartered in Alachua, FL, is seeking a quality leadership professional to oversee and improve quality systems within a regulated environment. You will ensure compliance, lead audits, and drive data-driven improvements across cross-functional teams.

The role emphasizes training delivery, documentation accuracy, and records management in a fast-paced, onsite setting. A Associate’s degree plus 3+ years in QA/regulatory roles are required.

Qualifications

• 3+ years of quality assurance, regulatory affairs, or other relevant experience in a regulated industry such as tissue, medical device, or pharmaceutical.
• 2+ years of leadership experience.
• A different combination of education and experience may be considered.

Responsibilities

• Oversees and executes functions within critical Quality Systems programs to ensure compliance with applicable regulations, standards and company objectives.
• Supports quality system compliance with internal and external regulatory requirements and maintains awareness of the regulatory landscape.
• Collects, analyzes, and reports data to demonstrate conformity and maintains effectiveness of the QMS with accuracy.
• Supports process improvement initiatives that impact quality systems and collaborates with cross-functional stakeholders to ensure compliance of processes.
• Lead internal and third-party audits and provide training for responsible processes.
• Reviews and approves quality system documentation for accuracy and compliance.
• Delivers training on responsible processes and coordinates daily team activities and performance management.
• Maintains records management system including secure storage and retention.

Skills

Communication

MS Office

QMS software

Problem solving

Data analysis

Records management

Education

Associate’s Degree

Job description

Evergen, headquartered in Alachua, FL, is seeking a quality leadership professional to oversee and improve quality systems within a regulated environment. You will ensure compliance, lead audits, and drive data-driven improvements across cross-functional teams.

The role emphasizes training delivery, documentation accuracy, and records management in a fast-paced, onsite setting. A Associate’s degree plus 3+ years in QA/regulatory roles are required.