Senior Compliance & Quality Assurance Leader

Advatix, Inc; United States; Remote; USD 120,000 - 170,000; Full time

Job summary

HRforGrowth is seeking a Compliance and Quality Assurance Manager to lead the development, implementation, and continuous improvement of quality, compliance, regulatory, and audit programs across assigned operations. You will ensure ongoing ISO 9001, GMP, FDA adherence and meet customer requirements.

You will manage a team of compliance professionals and collaborate with operations, quality, safety, and executive leadership to drive risk mitigation, CAPA, training, and performance improvements.

Qualifications

• Bachelor’s degree in Quality Management, Business, Engineering, Supply Chain, Life Sciences, or related field preferred.
• Minimum of 5 years of quality, compliance, regulatory, or operational excellence experience.
• Minimum of 3 years of leadership experience managing teams.
• Demonstrated experience supporting ISO 9001 environments; GMP and FDA exposure preferred.

Responsibilities

• Lead the development, implementation, and continuous improvement of the Quality Management System (QMS).
• Manage internal, customer, ISO, FDA, security, and regulatory audits.
• Own the CAPA process across all assigned operations and ensure timely closure.
• Provide training, mentoring, and development for the compliance team.
• Prepare monthly, quarterly, and annual compliance performance reports and dashboards.

Skills

Leadership

Quality Systems

Regulatory Compliance

Audits

CAPA

Problem Solving

Project Management

Communication

Influence Stakeholders

Education

Bachelor’s degree in Quality/Related field

Tools

QMS Software

MS Excel

Audit Tools

Job description

HRforGrowth is seeking a Compliance and Quality Assurance Manager to lead the development, implementation, and continuous improvement of quality, compliance, regulatory, and audit programs across assigned operations. You will ensure ongoing ISO 9001, GMP, FDA adherence and meet customer requirements.

You will manage a team of compliance professionals and collaborate with operations, quality, safety, and executive leadership to drive risk mitigation, CAPA, training, and performance improvements.