What are the responsibilities and job description for the Director of Quality Systems position at Frontage Laboratories?
Job Summary:
The Director of Quality Assurance, Pharmaceutical Manufacturing is responsible for leading the development, maintenance, and continuous improvement of quality management systems to ensure compliance and quality standards. The successful candidate will have strong leadership and communication skills, with the ability to collaborate with cross-functional teams.
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.
• Develop and approve quality agreements with clients, host client audits, and provide responses, ensuring action items are completed to meet requirements.
• Conduct internal audits and provide biannual quality KPI analysis to CMC/CDMO management.
• 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).
The Director of Quality Assurance, Pharmaceutical Manufacturing is responsible for leading the development, maintenance, and continuous improvement of quality management systems to ensure compliance and quality standards. The successful candidate will have strong leadership and communication skills, with the ability to collaborate with cross-functional teams.
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.
• Develop and approve quality agreements with clients, host client audits, and provide responses, ensuring action items are completed to meet requirements.
• Conduct internal audits and provide biannual quality KPI analysis to CMC/CDMO management.
• 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).
