Senior Quality Director, GMP & Regulatory Compliance

Corden Pharma - A Full-Service CDMO; North Augusta (SC); On-site; USD 180,000 - 240,000; Full time

Job summary

CordenPharma South Carolina is seeking a seasoned Quality Unit Director to lead and continuously improve the site's Quality Management System, ensuring global regulatory compliance and fostering a culture of quality excellence. You will partner with functions to support business objectives, customer satisfaction, and site success.

The role requires 15+ years in pharma/biotech, with 8+ in Quality Operations within CDMOs; CFR 21 and ICH GMP guidelines familiarity; strong leadership,

Qualifications

• BS/BA in chemistry or life science; Master’s degree preferred.
• 15+ years in Pharma/Biotech with at least 8 years in Quality Operations in CDMOs.
• Familiar with CFR 21 and ICH GMP guidelines.

Responsibilities

• Develop and implement an effective Quality Management System for GMP activities across development, manufacturing, testing and release of API.
• Implement and maintain a Quality Risk Management system.
• Ensure all activities comply with cGMP, global policies, and Health & Safety rules.
• Manage customer audits and Quality Agreements.
• Oversee FDA and Health Authority inspections and inspection readiness.
• Ensure validation/qualification activities meet international standards and approve related documents.
• Hire, coach, and manage QA/QC staff; provide performance feedback.
• Release API intermediate and final API batches.
• Coordinate quality issues with other departments and customers.
• Support CAPEX and Operational Excellence initiatives.
• Draft/regulatory DMF strategies for APIs and drug products (USA, EU, etc.).
• Escalate critical events to Global Quality per procedure.
• Draft/update DMF documents annually.

Skills

Quality management

GMP knowledge

Regulatory compliance

Leadership

Project management

Communication

Education

BS/BA in chemistry or life sciences

Master’s degree preferred

Tools

MS Word

Excel

Access

Job description

CordenPharma South Carolina is seeking a seasoned Quality Unit Director to lead and continuously improve the site's Quality Management System, ensuring global regulatory compliance and fostering a culture of quality excellence. You will partner with functions to support business objectives, customer satisfaction, and site success.

The role requires 15+ years in pharma/biotech, with 8+ in Quality Operations within CDMOs; CFR 21 and ICH GMP guidelines familiarity; strong leadership,