Position: Manager/Senior Manager/Associated Director of CMC QA
Level dependent on experience
Essential Duties and Responsibilities
- Support the development, implementation, and improvement of company quality systems
- Promote a culture of quality throughout the company and, increase compliance awareness with a focus on laboratory and manufacturing operations
- Collaborate with multiple functions to perform QA oversight and ensure quality-related activities are executed efficiently
- Write, review and revise standard operating procedures
- Review, revise and approve validation protocols
- Provide training to laboratory and manufacturing staff on GLP/GMP regulations, best practices and internal requirements
- Review and approve manufacturing-related documentation, including raw material release, batch records, quality control test results and resolve discrepancies, as needed
- Write inspection reports and prepare QA statements
- Review and approve Certificates of Analysis and/or Certificates of Test
- Perform internal and external audits of suppliers; assist in the resolution of non-conformances, deviations and investigations
- Track open observations and Corrective and Preventative Actions (CAPA) to closure
- Assist with the analysis of trends and metrics to ensure continuous quality improvements
- Travel up to 20%
- Other duties as assigned
Experience/Educational Qualifications
- B.S. degree in a scientific discipline and at least three (3) years’ QA experience (5 preferred) in a GLP/GMP environment, preferably in a biotechnology company
- In-depth understanding of GLP and GMP (drugs and biologics) regulations, guidance documents, systems, processes and procedures
- Great attention to detail
- Strong interpersonal skills
- Strong prioritization, organizational and negotiating skills
- Excellent verbal and written communication skills and ability to communicate effectively with site personnel, peers and management
- Solid time management skills and ability to handle multiple tasks and deliver high-quality results within set timelines
Supervisory Responsibilities
- This position does not have supervisory responsibilities
Please send CV and Cover Letter to hr@cellics.com to apply.