Metric Bio
Overview
Metric Bio are supporting a global leader in the biologics CDMO space as they search for an
Associate Director Quality Assurance . This is a renowned company in the space going through a serious phase of growth. Responsibilities
Establish and manage a Quality Management System (QMS) for a new site, ensuring compliance with global GMP standards. Oversee facility, utility, and equipment qualification, including FAT support. Develop and implement QA protocols, conduct audits, and drive corrective actions. Ensure accurate, compliant documentation of QC/QA processes. Recruit, train, and lead a high-performing quality team while fostering a strong compliance culture. Collaborate with cross-functional teams (R&D, Engineering, Manufacturing, Regulatory Affairs) to align on quality goals. Manage QA budgets, resources, and capital projects related to compliance. Support regulatory inspections, internal audits, and continuous improvement initiatives. What will you bring?
Bachelor’s degree or higher in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, Engineering, or a related discipline. 7+ years of experience in the pharmaceutical/biopharmaceutical industry. 5+ years of experience in quality-focused roles with proven leadership. Strong background in QMS implementation, facility/instrument qualification, and FAT support. Experience building and leading quality teams with a track record of fostering strong compliance culture. In-depth knowledge of GMP regulations and international guidelines (FDA, EMA, ICH, Pharmacopoeias, etc.). Skilled in audits, inspections, and regulatory interactions. Strong communication, stakeholder engagement, and budget management experience. Ability to manage multiple projects simultaneously while ensuring high standards of quality. Excellent analytical, problem-solving, and decision-making abilities. Strong interpersonal skills with the ability to influence and collaborate across functions. Willingness to travel occasionally as required. Note
We look forward to your application.
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Metric Bio are supporting a global leader in the biologics CDMO space as they search for an
Associate Director Quality Assurance . This is a renowned company in the space going through a serious phase of growth. Responsibilities
Establish and manage a Quality Management System (QMS) for a new site, ensuring compliance with global GMP standards. Oversee facility, utility, and equipment qualification, including FAT support. Develop and implement QA protocols, conduct audits, and drive corrective actions. Ensure accurate, compliant documentation of QC/QA processes. Recruit, train, and lead a high-performing quality team while fostering a strong compliance culture. Collaborate with cross-functional teams (R&D, Engineering, Manufacturing, Regulatory Affairs) to align on quality goals. Manage QA budgets, resources, and capital projects related to compliance. Support regulatory inspections, internal audits, and continuous improvement initiatives. What will you bring?
Bachelor’s degree or higher in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, Engineering, or a related discipline. 7+ years of experience in the pharmaceutical/biopharmaceutical industry. 5+ years of experience in quality-focused roles with proven leadership. Strong background in QMS implementation, facility/instrument qualification, and FAT support. Experience building and leading quality teams with a track record of fostering strong compliance culture. In-depth knowledge of GMP regulations and international guidelines (FDA, EMA, ICH, Pharmacopoeias, etc.). Skilled in audits, inspections, and regulatory interactions. Strong communication, stakeholder engagement, and budget management experience. Ability to manage multiple projects simultaneously while ensuring high standards of quality. Excellent analytical, problem-solving, and decision-making abilities. Strong interpersonal skills with the ability to influence and collaborate across functions. Willingness to travel occasionally as required. Note
We look forward to your application.
#J-18808-Ljbffr