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 requirements.
- Collaborate with clients to implement process improvements and corrective actions.
- Ensure customer-specific compliance requirements are integrated into operational processes.
Continuous Improvement
- Utilize Lean, Six Sigma, and continuous improvement methodologies to enhance compliance processes.
- Analyze data and compliance trends to identify improvement opportunities.
- Drive projects that reduce risk, improve audit performance, and increase operational effectiveness.
- Support cross-functional initiatives focused on quality, efficiency, and regulatory compliance.
Reporting & Governance
- Prepare monthly, quarterly, and annual compliance performance reports.
- Lead Management Review meetings and executive compliance reviews.
- Maintain compliance dashboards and key performance indicators.
- Present business updates and risk mitigation strategies to senior leadership.
Additional Responsibilities
- 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.
QUALIFICATIONS REQUIRED:
Education
- Bachelor's degree in Quality Management, Business, Engineering, Supply Chain, Life Sciences, or related field preferred.
- Equivalent combination of education and experience will be considered.
Experience
- 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.
- Strong experience with GMP, FDA, customer compliance, and audit management programs.
- Experience within logistics, supply chain, manufacturing, fulfillment, distribution, healthcare, or regulated environments preferred.
Knowledge & Skills
- 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.
Preferred Certifications
- Certified Quality Manager (CQM)
- Certified Quality Auditor (CQA)
- Six Sigma Green Belt or Black Belt
- ISO 9001 Lead Auditor Certification
About HRforGrowth
HRforGrowth is a full-service HR and talent partner built to support companies that are scaling, transforming, or navigating change. HRFG is globally recognized for delivering quality, speed, and cost-effective talent solutions across every level of the workforce. Through its global talent acquisition practice, HRforGrowth applies world class rigor and precision to identifying exceptional professional and executive talent on behalf of its clients - from temporary staffing to permanent hourly workers through to placing C-suite executives. HRforGrowth is presenting this opportunity in its capacity as the retained search partner and does not serve as the employer of record for this position.
Equal Employment Opportunity
In its recruiting and search practices, HRforGrowth does not discriminate on the basis of race, color, religion, national origin, age, marital status, physical or mental disability, sex, sexual orientation, gender, or gender identity, and welcomes applications from all qualified individuals. HRforGrowth evaluates and presents candidates to its clients without regard to any protected characteristic.
The hiring organization for this position is expected to comply with all applicable federal, state, and local equal employment opportunity laws - including those enforced by the U.S. Equal Employment Opportunity Commission (EEOC) - in its hiring decisions, terms of employment, and workplace practices.
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