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:
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