Compliance and Quality Assurance Manager

Advatix, Inc.•,

About The Position

The Compliance and Quality Assurance Manager leads, develops, implements, and continuously improves quality, compliance, regulatory, and audit programs across assigned operations. The role ensures compliance with ISO standards, Good Manufacturing Practices (GMP), FDA requirements, customer contractual obligations, security standards, and internal policies. As the subject matter expert for quality systems and regulatory compliance, this manager provides strategic guidance to site leadership and drives operational excellence, risk mitigation, and continuous improvement. The role leads compliance professionals and partners with operations, client services, quality, safety, and executive leadership to achieve compliance objectives. The position may be based in Detroit, Maple Grove, South Bend, Chicago, or within 50 miles of one of those locations, and requires travel of 40% as needed. The manager oversees the Quality Management System (QMS), audit programs, CAPA, compliance training, client and regulatory relationships, continuous improvement initiatives, and compliance reporting and governance. They lead and develop compliance and quality personnel, prepare performance reports and dashboards, and present audit findings, trends, and risk mitigation strategies to senior leadership.

Requirements

Minimum of 5 years of experience in quality, compliance, regulatory, or operational excellence.
Minimum of 3 years of leadership experience managing teams.
Demonstrated experience supporting ISO 9001 environments.
Strong experience with GMP, FDA, customer compliance, and audit management programs.
Strong understanding of ISO standards, GMP regulations, CAPA, root cause analysis, and quality management systems.
Excellent leadership, communication, and presentation skills.
Ability to influence leaders and stakeholders at all organizational levels.
Advanced analytical and problem-solving capabilities.
Strong project management and organizational skills.
Proficiency with Microsoft Office Suite, reporting tools, and quality management systems.
Ability to manage multiple priorities in a fast-paced operational environment.
Demonstrated ability to lead teams through change and process improvement initiatives.
Ability to travel 40% as required.

Nice To Haves

Bachelor's degree in Quality Management, Business, Engineering, Supply Chain, Life Sciences, or a related field; equivalent combinations of education and experience will be considered.
Experience within logistics, supply chain, manufacturing, fulfillment, distribution, healthcare, or other regulated environments.
Certified Quality Manager (CQM).
Certified Quality Auditor (CQA).
Six Sigma Green Belt or Black Belt.
ISO 9001 Lead Auditor Certification.

Responsibilities

Lead the development, implementation, maintenance, and continuous improvement of the Quality Management System (QMS).
Ensure ongoing compliance with ISO 9001, GMP, FDA, customer, and internal quality requirements.
Establish compliance strategies, goals, metrics, and reporting mechanisms across assigned facilities.
Monitor changes to regulatory and industry standards and implement required operational changes.
Serve as the Management Representative during external regulatory and client audits.
Develop and manage annual internal audit programs.
Lead internal, customer, ISO, FDA, security, and regulatory audits.
Ensure audit findings are documented, communicated, and resolved within required timelines.
Establish audit readiness programs and maintain facilities in a constant state of compliance.
Present audit findings, trends, and corrective action plans to senior leadership.
Own the CAPA process across assigned operations; ensure root cause analyses are conducted, monitor corrective action effectiveness and closure, and implement preventive measures for recurring issues.
Track compliance KPIs and recommend process improvements based on trend analysis.
Lead, coach, and develop Compliance Supervisors, Compliance Specialists, and Quality personnel; set goals and expectations, provide training and development, conduct performance reviews, and support succession planning.
Develop and oversee compliance, GMP, quality, and regulatory training programs; maintain and document training requirements.
Partner with operational leadership to improve compliance awareness and accountability, and support onboarding and certification programs for leadership and hourly associates.
Act as the primary compliance contact for clients and regulatory agencies.
Lead compliance reviews during customer implementations and business expansions; support customer audits, business reviews, and reporting requirements.
Collaborate with clients on process improvements and corrective actions, and integrate customer-specific compliance requirements into operational processes.
Use Lean, Six Sigma, and continuous improvement methodologies to enhance compliance processes.
Analyze data and compliance trends, drive projects that reduce risk and improve audit performance and operational effectiveness, and support cross-functional quality, efficiency, and compliance initiatives.
Prepare monthly, quarterly, and annual compliance performance reports; lead Management Review meetings and executive compliance reviews; maintain dashboards and KPIs; and present business updates and risk mitigation strategies to senior leadership.
Ensure regular and punctual attendance.
Travel 40% as required to support audits, client requirements, and operational initiatives.
Perform additional duties and special projects as assigned.