What are the responsibilities and job description for the Quality Assurance Director position at Frontage Laboratories?
Job Description:
The Director of Quality Assurance, Pharmaceutical Manufacturing plays a critical role in the development, maintenance, and continuous improvement of quality management systems to uphold quality standards and compliance. The successful candidate will ensure seamless integration with global quality processes.
Key Responsibilities:
• Manage the quality assurance department to support GLP and GMP manufacturing of drug dosage forms for preclinical and clinical trial studies, and commercial production.
• Manage internal audits and provide biannual quality KPI analysis to CMC/CDMO management.
• Host regulatory agent inspection such as FDA, EU QP, and DEA, providing responses to ensure quality compliance.
• Develop and approve quality agreements with clients, host client audits, and provide responses, ensuring action items are completed to meet requirements.
• Develop, implement, and oversee quality systems at Frontage manufacturing facilities to ensure product reliability, quality, efficacy, and alignment with global standards.
Requirements:
• BS or advanced degree in a scientific discipline or related area.
• 10-15 years of experience in pharmaceutical/biotech industry, including manufacturing, development, and quality.
• 6-8 years of experience in quality management and leadership positions.
• Strong knowledge of US, EMA, and ICH regulations, guidance, and industry standards for CGMP (21 CFR Part 210, 211).
• Experience hosting regulatory authorities' inspections and providing responses.
The Director of Quality Assurance, Pharmaceutical Manufacturing plays a critical role in the development, maintenance, and continuous improvement of quality management systems to uphold quality standards and compliance. The successful candidate will ensure seamless integration with global quality processes.
Key Responsibilities:
• Manage the quality assurance department to support GLP and GMP manufacturing of drug dosage forms for preclinical and clinical trial studies, and commercial production.
• Manage internal audits and provide biannual quality KPI analysis to CMC/CDMO management.
• Host regulatory agent inspection such as FDA, EU QP, and DEA, providing responses to ensure quality compliance.
• Develop and approve quality agreements with clients, host client audits, and provide responses, ensuring action items are completed to meet requirements.
• Develop, implement, and oversee quality systems at Frontage manufacturing facilities to ensure product reliability, quality, efficacy, and alignment with global standards.
Requirements:
• BS or advanced degree in a scientific discipline or related area.
• 10-15 years of experience in pharmaceutical/biotech industry, including manufacturing, development, and quality.
• 6-8 years of experience in quality management and leadership positions.
• Strong knowledge of US, EMA, and ICH regulations, guidance, and industry standards for CGMP (21 CFR Part 210, 211).
• Experience hosting regulatory authorities' inspections and providing responses.
