Manufacturing Quality Manager - South Bend, IN - $145k - $155k/year
Aegis Worldwide is seeking a Manufacturing Quality Manager to lead the site's quality strategy, ensuring compliance with regulatory and customer standards. The role includes managing quality teams, product monitoring, regulatory inspections, and continuous system improvements. Ideal candidates will have leadership experience in compliance management within regulated industries (cosmetic, pharmaceutical, or medical devices) and collaborate effectively with internal and external stakeholders.
Key Responsibilities:
Develop and execute the site quality strategy in partnership with the General Manager to ensure industry-leading production and quality standards.
Oversee site compliance with customer and regulatory agency requirements (FDA, Health Canada, EMA).
Lead all quality operations, including quality teams, batch release processes, nonconformance investigations, and customer complaints.
Manage Analytical, Microbiological, In-Process, and Incoming Inspection processes, as well as customer quality agreements and audits.
Ensure continuous improvement and staff training within the Quality Department.
Report KPIs and quality metrics to corporate and executive leadership.
Qualifications:
Bachelor's degree in sciences/engineering.
6+ years of experience in quality/regulatory leadership in a regulated industry (pharmaceutical, cosmetic, medical device).
Strong leadership, communication, and team-building skills with knowledge of cGMP, 21 CFR, USP standards.