Scorpion Therapeutics
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Director, GMP Quality Assurance Biologics. The successful candidate will serve as the primary Quality Assurance representative for Disc Medicine's Biologics pipeline, providing strategic and hands-on QA oversight for late-stage clinical trials, technology and method transfer, clinical manufacturing, and batch disposition. Reports to the Executive Director, GMP Quality Assurance, Biologics. Responsibilities
Provide quality partnership and oversight of Disc Medicine's Biologics manufacturing, testing and disposition of products (Biologics) and combination products (Biologic + Device) processes. Experience with prefilled syringes (PFS) and safety device assembly is required. Support ongoing technology transfer of drug product and device manufacturing processes and analytical methods to external CDMOs, ensuring late-stage GMP requirements to support pivotal clinical trials. Ensure compliance in the Quality Management System and CDMO manufacturing and testing operations with applicable GMP regulations (FDA, EU, ICH, ISO 13485, QMSR, MDR). Experience with Japanese regulatory requirements beneficial. Collaborate with cross-functional teams to draft, review and verify documents for Health Authority CMC submissions, including verification of documents, records, protocols, reports, and data. Develop, implement and approve risk-based quality system oversight related to CDMO manufacturing and testing of combination products, including deviations, investigations, change controls and CAPA. Partner with internal stakeholders to ensure program alignment and timely delivery of quality milestones. Identify and escalate quality risks while driving effective, compliant resolutions and fostering a quality culture in a fast-paced, matrixed environment. Qualifications
Bachelor's Degree in a scientific discipline or related field. 12-15 years of progressive Quality Assurance experience, with experience in Technology Transfer, Global QMS design/implementation, and managing combination products (prefilled syringes required). Hands-on expertise with Combination Products (Device and Biologic) including developing QMS processes that guide manufacturing, QC testing, and supply chain. Proven track record in building a quality culture with experience in GMP operations, quality agreements, vendor management, investigations, change management, and inspection readiness. Experience with CMC, development programs, quality management reviews, and vendor joint steering committees. Desirable experience across clinical development of biologics (Pre-Clinical to Licensure) and direct discussions with Health Authorities. Self-driven, highly organized, with proven ability to build cross-functional relationships and communicate complex issues clearly. Ability to travel nationally and internationally (10-20%). Skills
Quality Assurance leadership GMP compliance (FDA, EU, ICH, ISO 13485, MDR) Technology Transfer and Vendor/CMC management Risk-based quality systems; deviations, investigations, CAPA Cross-functional collaboration and communication Regulatory submissions support Education
Bachelor's Degree in a scientific discipline (required). Additional Requirements
Ability to travel 10-20% nationally and internationally.
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A free trial of JobsAI can help. With over 2,000 biopharma executives loving it, we think you will too! Role Summary
Director, GMP Quality Assurance Biologics. The successful candidate will serve as the primary Quality Assurance representative for Disc Medicine's Biologics pipeline, providing strategic and hands-on QA oversight for late-stage clinical trials, technology and method transfer, clinical manufacturing, and batch disposition. Reports to the Executive Director, GMP Quality Assurance, Biologics. Responsibilities
Provide quality partnership and oversight of Disc Medicine's Biologics manufacturing, testing and disposition of products (Biologics) and combination products (Biologic + Device) processes. Experience with prefilled syringes (PFS) and safety device assembly is required. Support ongoing technology transfer of drug product and device manufacturing processes and analytical methods to external CDMOs, ensuring late-stage GMP requirements to support pivotal clinical trials. Ensure compliance in the Quality Management System and CDMO manufacturing and testing operations with applicable GMP regulations (FDA, EU, ICH, ISO 13485, QMSR, MDR). Experience with Japanese regulatory requirements beneficial. Collaborate with cross-functional teams to draft, review and verify documents for Health Authority CMC submissions, including verification of documents, records, protocols, reports, and data. Develop, implement and approve risk-based quality system oversight related to CDMO manufacturing and testing of combination products, including deviations, investigations, change controls and CAPA. Partner with internal stakeholders to ensure program alignment and timely delivery of quality milestones. Identify and escalate quality risks while driving effective, compliant resolutions and fostering a quality culture in a fast-paced, matrixed environment. Qualifications
Bachelor's Degree in a scientific discipline or related field. 12-15 years of progressive Quality Assurance experience, with experience in Technology Transfer, Global QMS design/implementation, and managing combination products (prefilled syringes required). Hands-on expertise with Combination Products (Device and Biologic) including developing QMS processes that guide manufacturing, QC testing, and supply chain. Proven track record in building a quality culture with experience in GMP operations, quality agreements, vendor management, investigations, change management, and inspection readiness. Experience with CMC, development programs, quality management reviews, and vendor joint steering committees. Desirable experience across clinical development of biologics (Pre-Clinical to Licensure) and direct discussions with Health Authorities. Self-driven, highly organized, with proven ability to build cross-functional relationships and communicate complex issues clearly. Ability to travel nationally and internationally (10-20%). Skills
Quality Assurance leadership GMP compliance (FDA, EU, ICH, ISO 13485, MDR) Technology Transfer and Vendor/CMC management Risk-based quality systems; deviations, investigations, CAPA Cross-functional collaboration and communication Regulatory submissions support Education
Bachelor's Degree in a scientific discipline (required). Additional Requirements
Ability to travel 10-20% nationally and internationally.
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