Quality Assurance & Compliance Manager

Our client, a global leader in the personal care/cosmetic manufacturing, is in growth mode and currently hiring for a QA & Compliance Manager.

They provide a world-class employee experience and the opportunity to work with best-in-class technology and equipment in a clean and safe facility.

Location
:
Onsite role in South Bend, IN (relocation assistance offered)

Shift
: ~8a-5p M-F

Salary
: $125-135K

The Quality Assurance & Compliance Manager will oversee all aspects of quality operations at a high-volume manufacturing facility. This role ensures compliance with regulatory standards, internal specifications, and customer expectations by managing quality systems, compliance programs, and continuous improvement initiatives. The position requires leadership, strategic alignment with business objectives, and the ability to foster a high-performance culture within a regulated manufacturing environment.

• Lead, mentor, and develop the QA team; align quality objectives with business goals and regulatory requirements; serve as a key member of site leadership influencing cross-functional decision-making.
• Manage investigations (NCPs, deviations, CAPA), change control, plant procedures (Level I–III), and annual product reviews. Ensure effective governance of quality systems.
• Lead internal audit program, act as site contact for external audits (customer/regulatory), ensure audits (Internal & external)/regulatory inspection readiness, prepare responses, and drive sustainable CAPA implementation.
• Maintain compliance with FDA, GMP, ISO, and other standards; monitor/report KPIs (CAPA effectiveness, audit scores, complaints, training); present updates to leadership and stakeholders.
• Oversee calibration, quality training (onboarding, cGMP, role-specific modules), and complaint handling investigations with trend analysis.
• Champion Lean, Six Sigma, and other quality methodologies; identify systemic issues and implement preventive/corrective actions to enhance efficiency.
• Support corporate initiatives related to quality and compliance.
• Collaborate with cross-functional teams to resolve product integrity issues.
• Participate in strategic projects, including systems upgrades and policy harmonization.
• Represent the facility in corporate, customer facing or external quality forums.
• Travel (up to 10–15%) for audits, training, and corporate meetings.
• Some duties may vary slightly by location.

• Bachelor's Degree in Chemistry, Engineering, Life Sciences, or related field;
  Master’s (Preferred)

• 7-9 years of progressive QA experience in regulated manufacturing (OTC, pharma, cosmetics, personal care) with 3+ years in leadership. (Preferred)
• 7-9 years FDA regulations, GMP, ISO standards, electronic QMS platforms. (Preferred)
• 7-9 years proven success leading audits, managing CAPA, and driving compliance initiatives. (Preferred)
• 7-9 years communication, analytical, leadership, and problem-solving abilities. (Preferred)

• Deep understanding of FDA, GMP, ISO, and related compliance frameworks. (High proficiency)
• Ability to oversee CAPA, deviations, audits, training, calibration, and complaint handling. (High proficiency)
• Ability to mentor, coach, and foster high-performance culture. (High proficiency)
• Skilled in preparing for, leading, and responding to external/internal audits. (High proficiency)
• Apply CI methodologies to reduce risk and enhance efficiency. (High proficiency)
• Root cause analysis, trend analysis, and data-driven decision-making. (High proficiency)
• Clear, persuasive communication across functions and with stakeholders. (High proficiency)
• Ability to prioritize, manage timelines, and deliver cross-functional quality initiatives. (High proficiency)

• Auditor certification (ASQ CQA, ISO Lead Auditor) (Preferred)