What are the responsibilities and job description for the Compliance and Risk Management position at Frontage Laboratories?
Overview:
We are looking for a highly skilled Director of Quality Assurance, Pharmaceutical Manufacturing to join our team. The successful candidate will be responsible for leading the quality management team, ensuring compliance and quality standards, and collaborating with cross-functional teams.
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 implement quality systems at Frontage manufacturing facilities to ensure product reliability, quality, efficacy, and alignment with global standards.
• Host regulatory agent inspections such as FDA, EU QP, and DEA, providing responses to ensure quality compliance.
• Develop, maintain, and continuously review and approve quality documents such as SOPs, change controls, OOS, deviations, CAPAs, MV protocols, MV reports, batch records, COA, and product release with the statement of GMP compliance.
• Provide staff annual GMP training with expertise and guidance in interpreting and implementing government and agency guidelines to ensure current GMP compliance.
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 looking for a highly skilled Director of Quality Assurance, Pharmaceutical Manufacturing to join our team. The successful candidate will be responsible for leading the quality management team, ensuring compliance and quality standards, and collaborating with cross-functional teams.
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 implement quality systems at Frontage manufacturing facilities to ensure product reliability, quality, efficacy, and alignment with global standards.
• Host regulatory agent inspections such as FDA, EU QP, and DEA, providing responses to ensure quality compliance.
• Develop, maintain, and continuously review and approve quality documents such as SOPs, change controls, OOS, deviations, CAPAs, MV protocols, MV reports, batch records, COA, and product release with the statement of GMP compliance.
• Provide staff annual GMP training with expertise and guidance in interpreting and implementing government and agency guidelines to ensure current GMP compliance.
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).
