Apex Systems
Executive Director, Quality Assurance, GMP
Apex Systems, Boston, Massachusetts, us, 02298
Executive Director, Quality Assurance, GMP
Executive Director, Quality Assurance, GMP 2034727Location : Boston, MA (Hybrid)Science:
Small Molecule TherapeuticsJob Overview:
The Executive Director, Quality Assurance, GMP will oversee internal and external GMP quality and leverage extensive quality and manufacturing experience from all clinical phases into commercialization.Primary Job Responsibilities:Lead quality assurance for CMO-related activities, overseeing GMP compliance for manufacturing, testing, and release processes along with batch reviews and tech transfers.Drive collaboration between internal CMC teams and external partners, aligning quality goals from clinical to commercial phases, and ensure the implementation of compliant and effective quality practices.Prepare for quality audits and inspections by managing quality documentation and leading discussions in meetings to maintain product excellence and compliance.Promote a culture of quality within the organization, set strategic objectives, manage the quality budget, and oversee personnel development and global compliance initiatives.Primary Job Requirements:Bachelors in life sciences with 12+ years in GMP quality leadership, expertise bringing pharmaceutical products through clinical stage into production, and experience in external manufacturing model are required.Well-versed in global GxP standards, capable of managing fast-paced environments, and skilled in navigating health authority expectations.Excels in leading teams and projects, demonstrating a successful track record with suppliers and CMOs, underpinned by in-depth knowledge from drug development to market.Champions continuous quality improvement, adept at working independently, setting priorities, and driving team excellence through effective management and communication.
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Executive Director, Quality Assurance, GMP 2034727Location : Boston, MA (Hybrid)Science:
Small Molecule TherapeuticsJob Overview:
The Executive Director, Quality Assurance, GMP will oversee internal and external GMP quality and leverage extensive quality and manufacturing experience from all clinical phases into commercialization.Primary Job Responsibilities:Lead quality assurance for CMO-related activities, overseeing GMP compliance for manufacturing, testing, and release processes along with batch reviews and tech transfers.Drive collaboration between internal CMC teams and external partners, aligning quality goals from clinical to commercial phases, and ensure the implementation of compliant and effective quality practices.Prepare for quality audits and inspections by managing quality documentation and leading discussions in meetings to maintain product excellence and compliance.Promote a culture of quality within the organization, set strategic objectives, manage the quality budget, and oversee personnel development and global compliance initiatives.Primary Job Requirements:Bachelors in life sciences with 12+ years in GMP quality leadership, expertise bringing pharmaceutical products through clinical stage into production, and experience in external manufacturing model are required.Well-versed in global GxP standards, capable of managing fast-paced environments, and skilled in navigating health authority expectations.Excels in leading teams and projects, demonstrating a successful track record with suppliers and CMOs, underpinned by in-depth knowledge from drug development to market.Champions continuous quality improvement, adept at working independently, setting priorities, and driving team excellence through effective management and communication.
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