Job Scope & Purpose:
Our Greater Boston-area client, with a pipeline focused in CNS and autoimmune disorders, is seeking an exceptional Quality Assurance leader. The ideal candidate will oversee all GXP QA and Quality Systems execution, from optimization and implementation of current systems and practices, to strategic planning and hands-on execution, and oversee a small QA team. Are you that leader, with the expertise that can take this group and organization to the next stage of development? If so, apply now.
Primary Job Responsibilities:
Establish and maintain phase appropriate Quality Systems
Lead Quality and Compliance oversight for all activities in manufacturing, supply chain, nonclinical and clinical
Ensure GXP compliance of internal and outsourced Quality Management practices and procedures through Supplier Management
Oversee internal Quality Systems training and day-to-day Quality function activities of internal team members, consultants and auditors
Manage GXP audit program against FDA/ICH/EMA requirements and other regulatory standards, and ensure timely resolution of any issues
Quality Management of external partners (CMOs, CROs, etc.) to ensure compliance of manufacturing and testing of company products
Lead Regulatory inspection preparation and management
Provide mentorship and leadership for the Quality team
Primary Job Requirements:
BS in applicable pharmaceutical science with at least 12 years of managerial experience in a Quality function, including strong preferred experience of leading a Quality function
Expertise in GXP practices and industry standards required
Experience in working with multiple external vendors in a virtual environment strongly preferred
Experience with development programs ranging from early stage to commercial strongly preferred
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