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The Associate Director of Quality Compliance supports the site’s Quality Management System (QMS) and compliance programs across the Round Lake Drug Delivery network. This role provides operational leadership for audits, training, documentation, change control, and inspection readiness activities.
Job Responsibility:
Lead day‑to‑day activities within the site’s Quality Compliance programs
Coordinate readiness assessments and preparation activities for regulatory inspections and corporate audits
Lead internal audits, supplier audits, and follow‑up activities
Assist in evaluating regulatory updates and enforcement trends
Oversee controlled documentation processes
Manage training system execution
Lead change control processes
Lead or support remediation teams focused on resolving compliance gaps
Work closely with QA Ops, Engineering, Manufacturing, Facilities, Supply Chain, and Regulatory Affairs
Manage and develop Quality Compliance staff
Requirements:
Bachelor’s degree in science or engineering required
advanced degree preferred
10+ years of experience in Quality Compliance/Quality Systems
3–5 years leadership
Recent pharmaceutical manufacturing experience is required
Strong knowledge of FDA/EMA regulations, QMS elements, and audit/inspection processes
Proven ability to lead audits, manage documentation systems, and drive compliance improvements
What we offer:
Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
medical and dental coverage that start on day one
insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance