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We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Associate Director of GMP Quality Control, who oversees GMP compliance of manufacturing, testing and release activities for SMPA, its partners, contract testing laboratories, and suppliers of drug substances and drug products used for investigational clinical trials and/or commercial phases.
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Associate Director, GMP Quality Control. Experience working in more than one product area (e.g. solid oral dose, injectables, combination products), and therapeutic area (e.g. oncology, urology, regenerative medicine) within Quality Control a plus.
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Maintain reports of onsite and offsite quality control inspections and tests performed including work by suppliers and subcontractors. Implement and manage Quality Control Program per contract specifications and project QC Plan.
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Responsible for compliance with regulatory filings and therefore must have experience in a Quality Assurance and/or Quality Control function for marketed pharmaceutical products or clinical trial materials.
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Enhance quality control practices and optimize internal processes by contributing to the preparation, review and approval of standard procedures and electronic systems. Advanced knowledge and use of software applications, including LC chromatographic analyses, statistical applications, and quality management systems (e.g. Veeva.
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For CMOs with aseptic processing, review media fills, and environmental monitoring data as it relates to lot release, change control and facility re-starts. Review and approve Quality Events, Investigations, CAPA, Change Controls, and Complaints in eQMS.
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Contribute to product development by making recommendations for manufacturing controls, sampling and testing to ensure product quality and compliance with GMPs from development through commercialization.
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Participate, as needed, in audits of contract laboratory sites and support annual Risk Assessments as part of the Supplier Quality program. Experience in evolving GMP related quality systems, policies, and procedures to ensure compliance with evolving standards as well as improving the efficiency of related workflows.
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Quality leader and quality culture promoter within the global organization. 8+ years of experience required, with relevant experience in biotech or pharmaceutical industry with most experience in a Quality role.
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Expertise in design of method validation, transfer, and stability studies consistent with regulatory, quality, and pharmaceutical best practices (e.g., USP, ICH). Strategic and tactical in the planning and execution of quality initiatives and activities.
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Provide quality management oversight of analytical activities with domestic and international contract manufacturing organizations and testing laboratories, and with internal and external partners.
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Lead OOS, OOT, and analytical quality events in eQMS. Provides guidance to internal and external partners on Phase 1b investigations to ensure investigations are conducted according to SMPA requirements, Quality Agreements, and regulatory expectations.
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Self-motivated, flexible, and able to prioritize work and handle multiple assignments in a fast-paced environment, while maintaining a high level of quality and compliance. Create, edit, and manage Quality Agreements for contract laboratories.
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Experience desired with drug delivery devices, diagnostics, biomarker, and genetic testing. Sumitomo Pharma America (SMPA) is focused on delivering therapeutic and scientific breakthroughs in areas of critical patient need spanning psychiatry & neurology, oncology, urology, women's health, rare disease, and cell & gene therapies.
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Well versed in analytical and characterization procedures for biopharmaceuticals and small molecules including HPLC, GC, MS, electrophoresis, immunoassays, bioburden, endotoxin, moisture, assay, and dissolution testing.
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quality control jobs Title: quality control representative Company: Thermo Fisher Scientific
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