Director, QA |
APPLY
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Scope of Function: Responsible for overseeing the Quality Assurance and Documentation Control. Assure quality systems and standard operating procedures are in compliance with appropriate regulations such as cGMP regulations
Specific Duties:
Education, Experience and Skills Required:
Education:
Interacts With:
Specific Duties:
- Guide Quality Assurance personnel activities
- Develop and implement Quality Management system, departmental policies and procedures and provide support and guidance to the daily operations of facilities and controls
- Appraise management of quality issues and work with them to resolves them
- Write and/or revise SOPs and Quality System Manual
- Ensure materials are handled in cGMP compliant manner
- Coordinate/perform Internal and External Audits
- Participate in client and regulatory agency audit/inspections
- Investigate root cause for failures, noncompliance, customer complaints and implement corrective and preventive action (CAPA)
- Conduct/assist/organize company-wide annual training in GMP/GDP compliance
- Attend production meetings and other meetings as required
- Prepare CMC sections of regulatory submission documents including IND and BLA
- Experience with commercial manufacturing of approved biologics is required
Education, Experience and Skills Required:
Education:
- Bachelor’s degree in Life Sciences or a related scientific field
- Minimum of seven years experience working in an FDA regulated environment for manufacturing of Biopharmaceuticals and Biologics
- Commercial manufacturing of approved biologics is required
- Experience and proficiency in technical writing are also required
Interacts With:
- Quality Control, cGMP Manufacturing, Project Management, Clients, Consultants and the Food and Drug Administration