Requirements:
- Bachelor’s degree in a related field of science, or equivalent formal training and experience
- A minimum of ten (10) years working in a Quality Manager role under cGMP
- Thorough knowledge of GMP principals, specifically 21 CFR 211 and ICH Q7
- Experience with electronic Quality Management Systems
Preferences:
- Prior Quality Managerial experience in a fast-faced regulated environment
- Experience in API Manufacturing and/or a chemical manufacturing environment
- Experience as an administrator of electronic quality management systems
- Regulatory Compliance experience
Skills:
- Excellent writing and communication skills
- Proficient with Microsoft Office software; experience building and using databases (e.g. Microsoft Access);
- Self-motivated and able to work independently when necessary, set goals, organize and follow project plans due meet pre-determined deadlines
- Thorough, detail oriented and willing to follow through on all aspects of a task required for successful completion
- Ability to thrive in a very fast-paced API contract manufacturing environment
Responsibilities:
- Proactively perform Quality Assurance functions in full compliance with current Good Manufacturing Practices (cGMP)
- Demonstrated working knowledge of 21 CFR 211 and ICH Q7. Understanding of EMA Quality standards and principles preferred
- Manage team of Quality Assurance Specialists for daily planning, maintenance and operation of the company’s quality systems, including but not limited to:
- Batch Record Review & Batch Release
- Quality Investigations (including Deviation Control)
- Material control
- Training (including job-skills and effectiveness)
- Change control
- Corrective Action / Preventative Action (including effectiveness)
- Customer Complaints
- Manage team of Document Specialists operating the site’s document control system, including:
- Documentation review and approval
- Document Change control
- Record Retention of Quality Records (Archival and retrieval)
- Contribute to the Supplier Qualification program, including documentation, correspondence and external auditing required for vendor approval and ongoing compliance
- Contribute to the internal audit program to ensure continued compliance to the Quality Program and cGMP
- Maintain system for monitoring of Quality Metrics for reporting (Local Management and Corporate)
- Contribute and provide oversight to Management Quality Review (QMR) Program