HRforGrowth® is engaged as the exclusive talent acquisition partner to conduct this search on behalf of a client organization that is hiring for this role. HRforGrowth is not the employer for this position. HRforGrowth identifies, evaluates, and presents top-tier candidates through its global talent acquisition practice; all employment decisions — including final selection, offer terms, compensation, and conditions of employment — are made solely by the hiring organization.
This position can be based in Detroit, Maple Grove, South Bend, Chicago or within driving distance (50 miles) of one of our locations listed.
Compliance and Quality Assurance Manager
Key Responsibilities
The Compliance and Quality Assurance Manager is responsible for the leadership, development, implementation, and continuous improvement of all quality, compliance, regulatory, and audit programs across assigned operations. This position ensures ongoing compliance with ISO standards, Good Manufacturing Practices (GMP), FDA requirements, customer contractual obligations, security standards, and internal policies.
The Compliance and Quality Assurance Manager serves as the subject matter expert for quality systems and regulatory compliance, providing strategic guidance to site leadership while driving operational excellence, risk mitigation, and continuous improvement initiatives. This role leads a team of compliance professionals and partners closely with operations, client services, quality, safety, and executive leadership to ensure compliance objectives are achieved.
MAJOR AREAS OF PERFORMANCE
Compliance & Quality Systems Leadership 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.
Audit Management Develop and manage annual internal audit programs.
Lead all 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.
Corrective and Preventive Actions (CAPA) Own the CAPA process across all assigned operations.
Ensure root cause analyses are conducted utilizing structured problem-solving methodologies.
Monitor corrective action effectiveness and closure.
Identify recurring issues and implement preventive measures to reduce risk and improve performance.
Track compliance KPIs and recommend process improvements based on trend analysis.
Team Leadership Lead, coach, and develop Compliance Supervisors, Compliance Specialists, and Quality personnel.
Establish departmental goals and performance expectations.
Provide training, mentoring, and professional development opportunities for compliance team members.
Conduct performance reviews and succession planning activities.
Foster a culture of accountability, continuous improvement, and quality excellence.
Training & Development Develop and oversee compliance, GMP, quality, and regulatory training programs.
Ensure compliance training requirements are maintained and documented.
Partner with operational leadership to improve compliance awareness and accountability.
Support onboarding and certification programs for leadership and hourly associates.
Client & Regulatory Partnership 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 compliance reporting…