Astrix · 13 hours ago
Quality Assurance Compliance Manager
South Bend, IN
Full-time
Onsite
Senior Level
$125K/yr - $135K/yr
7+ years expAstrix is a global leader in personal care and cosmetic manufacturing, currently seeking a Quality Assurance & Compliance Manager. This role oversees all aspects of quality operations at a high-volume manufacturing facility, ensuring compliance with regulatory standards and managing quality systems.
ConsultingInformation Technology
Hiring Manager
Emily Streb
Responsibilities
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
Qualification
Required
Bachelor's Degree in Chemistry, Engineering, Life Sciences, or related field
Deep understanding of FDA, GMP, ISO, and related compliance frameworks
Ability to oversee CAPA, deviations, audits, training, calibration, and complaint handling
Ability to mentor, coach, and foster high-performance culture
Skilled in preparing for, leading, and responding to external/internal audits
Apply CI methodologies to reduce risk and enhance efficiency
Root cause analysis, trend analysis, and data-driven decision-making
Clear, persuasive communication across functions and with stakeholders
Ability to prioritize, manage timelines, and deliver cross-functional quality initiatives
Preferred
Master's Degree in Chemistry, Engineering, Life Sciences, or related field
7-9 years years of progressive QA experience in regulated manufacturing (OTC, pharma, cosmetics, personal care) with 3+ years in leadership
7-9 years FDA regulations, GMP, ISO standards, electronic QMS platforms
7-9 years proven success leading audits, managing CAPA, and driving compliance initiatives
7-9 years communication, analytical, leadership, and problem-solving abilities
Auditor certification (ASQ CQA, ISO Lead Auditor)
Benefits
Relocation assistance offered
Company
Astrix
Astrix is the unrivaled market-leader in creating & delivering innovative strategies, solutions, and people to the life science community.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Dale Curtis
Chief Executive Officer
Reid E. Simpson
Chief Financial Officer
Recent News
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