Senior Quality Systems Leader – Audits, CAPA & Compliance

Job Juncture; Gainesville (FL); On-site; USD 120,000 - 180,000; Full time

Job summary

Job Juncture is seeking a senior Quality/Regulatory leader to manage site-wide Quality Systems and drive compliance across audits, document control, NC/CAPA and post-market surveillance activities. The role requires extensive experience in regulated industries, particularly Medical Devices or Pharma, and leadership of cross-functional teams.

The ideal candidate has a Bachelor's degree in life sciences, 10+ years in a regulated field, 5+ years in Quality/Regulatory Affairs, and hands-on

Qualifications

• Bachelor's degree in life sciences or related field preferred.
• 10+ years' experience in a regulated industry, preferably Medical Devices or Pharma.
• 5+ years in Quality or Regulatory Affairs.
• 3+ years managing staff.
• Experience with FDA Part 820, Part 1271, ISO 13485, or AATB standards.
• Experienced in supporting NC/CAPA and audit responses.

Responsibilities

• Oversees site-wide Quality Systems programs and teams to drive quality activity and compliance.
• Manages audits, document control, NC/CAPA and post-market surveillance activities.

Skills

Regulatory affairs

Quality systems

Audits management

Staff leadership

NC/CAPA

FDA standards

Education

Bachelor's degree in life sciences

Job description

Job Juncture is seeking a senior Quality/Regulatory leader to manage site-wide Quality Systems and drive compliance across audits, document control, NC/CAPA and post-market surveillance activities. The role requires extensive experience in regulated industries, particularly Medical Devices or Pharma, and leadership of cross-functional teams.

The ideal candidate has a Bachelor's degree in life sciences, 10+ years in a regulated field, 5+ years in Quality/Regulatory Affairs, and hands-on