What are the responsibilities and job description for the Pharmaceutical Manufacturing Lead position at Frontage Laboratories?
About the Role:
We are seeking an experienced Director of Quality Assurance, Pharmaceutical Manufacturing to lead our quality management team. The successful candidate will be responsible for developing, maintaining, and improving quality management systems to ensure compliance and quality standards.
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.
• Conduct internal audits and provide biannual quality KPI analysis to CMC/CDMO management.
• 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.
• Collaborate with cross-functional teams to identify and mitigate risks and deficiencies.
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).
We are seeking an experienced Director of Quality Assurance, Pharmaceutical Manufacturing to lead our quality management team. The successful candidate will be responsible for developing, maintaining, and improving quality management systems to ensure compliance and quality standards.
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.
• Conduct internal audits and provide biannual quality KPI analysis to CMC/CDMO management.
• 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.
• Collaborate with cross-functional teams to identify and mitigate risks and deficiencies.
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).
