Executive Director, Site Quality Lead
confidentialSalt Lake City, UT
Executive Director, Site Quality Lead
L7
confidentialSalt Lake City, UT5 days ago
Industries
Pharmaceutical Preparation ManufacturingResearch and Development in BiotechnologyBiological Product ManufacturingExecutive Director, Site Quality LeadAbout the Company Innovative biotechnology company IndustryPharmaceuticalsTypePublic Company Founded2015Employees501-1000 Categories PharmaceuticalsBiotechnologyHealth Care Medical Conditions Clinical Care BiotechAcademic Research CollaborationManufacturingMedicineChemical Products Specialtiesbiotechnologyneurodegenerative diseaseneurodegenerationand pharmaceuticals
About the Role:
The Company is seeking an Executive Director & Site Quality Lead to join their team. The successful candidate will be a key member of the site leadership team, with a primary focus on building and leading the QA and QC teams to ensure the site is in a state of readiness for commercial product launch. This role is pivotal in fostering a culture of innovation, continuous improvement, and adherence to core values. The Executive Director will be responsible for overseeing GMP/GLP quality operations, including quality control laboratories, batch record reviews, and environmental monitoring. They will also be accountable for the site's overall compliance and inspection readiness, serving as a strategic partner in developing and maintaining site culture and long-term strategy. Applicants for this role at the company should have a BS in a scientific discipline, with an MS and professional certification in quality, compliance, and/or regulatory preferred, and at least 15 years' GMP experience in the pharmaceutical industry. A strong background in in-house manufacturing, QC testing, and CMC development is essential, with experience in large molecule or commercialization being a plus. The ideal candidate will have a current and strong working knowledge of relevant regulatory guidelines and experience in inspection management and health authority interactions. The role requires the ability to travel domestically and internationally and a proven track record in leading and developing teams. Hiring Manager TitleVice President of Quality FunctionsOperations
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Level
ManagerL7
Location
Salt Lake City, UT
Occupation
Quality Control Systems Managers
Industry
Pharmaceutical Preparation Manufacturing
Posted
5 days ago
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