Associate Director, API Supplier Quality Management
Scorpion Therapeutics, Indiana, Pennsylvania, us, 15705
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Role Summary Associate Director, API Supplier Quality Management leads quality oversight of the precursor (API) manufacturing program supporting the production of PET and Radioligand radiopharmaceutical drug products. This role ensures the effective management and routine quality oversight of contracted manufacturers, service providers and related suppliers and vendors of materials and components. This position also provides operational support of commercial QC laboratories. The role collaborates with cross-functional teams to qualify and manage precursor materials, establish and maintain standard operating procedures and quality agreements, and develop strategies to fulfill responsibilities, continually enhance the quality system, and identify operational efficiencies.
Responsibilities Leads the qualification and quality oversight of contract manufacturers and associated suppliers and service providers Designs and enhances the risk-based precursor program and leads efforts to update established procedures in alignment with Lilly corporate quality standards Completes sponsor release and manages quality distribution activities for precursor and reference standard Reviews and approves the validation and testing method transfers for precursor and reference standard methods ensuring compliance with ICH and Lilly quality standards Collaborates with cross functional team members and external contract manufacturing partners to investigate and resolve manufacturing issues Develops, executes and maintains supplier quality agreements Coordinates audit scheduling with the global compliance team and serves as an audit team member or facilitator, as required Authors precursor section of annual product review and periodic quality management review Partners with supplier quality management to support supplier periodic reviews and change notification assessments Educates and mentors team members on quality requirements and expectations
Qualifications Minimum 5 years’ experience in pharmaceutical manufacturing or Quality Assurance. Preferred strong chemistry background in API production. Authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.
Education Bachelor’s degree - Preferred in a scientific discipline relevant to drug discovery, development, pharmacy, biology, or chemistry
Skills Strong knowledge of commercial and investigational drug product quality management Thorough knowledge of applicable regulations, such as global GMP regulations: US, EU, Japan, ICH Q7 along with IPEC, and ISO standards and the ability to interpret and apply them Experience with API manufacturing validation and analytical method validation Familiarity with writing and revising Quality Agreements Proficient in root causes analysis, review and approval of deviations/investigations, quality assessment of CAPA Plans and change controls Ability to simplify complex processes/problems and propose alternate solutions Quality oversight experience with third party/contract manufacturing Demonstrated negotiation and influence skills Demonstrated written, and interpersonal communication, and project management skills Knowledge of radiopharmaceutical manufacturing GMP’s Able to communicate effectively in both written and verbal forms to both internal and external customers
Additional Requirements Ability to travel domestically and internationally from 10-25%, as required.
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Role Summary Associate Director, API Supplier Quality Management leads quality oversight of the precursor (API) manufacturing program supporting the production of PET and Radioligand radiopharmaceutical drug products. This role ensures the effective management and routine quality oversight of contracted manufacturers, service providers and related suppliers and vendors of materials and components. This position also provides operational support of commercial QC laboratories. The role collaborates with cross-functional teams to qualify and manage precursor materials, establish and maintain standard operating procedures and quality agreements, and develop strategies to fulfill responsibilities, continually enhance the quality system, and identify operational efficiencies.
Responsibilities Leads the qualification and quality oversight of contract manufacturers and associated suppliers and service providers Designs and enhances the risk-based precursor program and leads efforts to update established procedures in alignment with Lilly corporate quality standards Completes sponsor release and manages quality distribution activities for precursor and reference standard Reviews and approves the validation and testing method transfers for precursor and reference standard methods ensuring compliance with ICH and Lilly quality standards Collaborates with cross functional team members and external contract manufacturing partners to investigate and resolve manufacturing issues Develops, executes and maintains supplier quality agreements Coordinates audit scheduling with the global compliance team and serves as an audit team member or facilitator, as required Authors precursor section of annual product review and periodic quality management review Partners with supplier quality management to support supplier periodic reviews and change notification assessments Educates and mentors team members on quality requirements and expectations
Qualifications Minimum 5 years’ experience in pharmaceutical manufacturing or Quality Assurance. Preferred strong chemistry background in API production. Authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.
Education Bachelor’s degree - Preferred in a scientific discipline relevant to drug discovery, development, pharmacy, biology, or chemistry
Skills Strong knowledge of commercial and investigational drug product quality management Thorough knowledge of applicable regulations, such as global GMP regulations: US, EU, Japan, ICH Q7 along with IPEC, and ISO standards and the ability to interpret and apply them Experience with API manufacturing validation and analytical method validation Familiarity with writing and revising Quality Agreements Proficient in root causes analysis, review and approval of deviations/investigations, quality assessment of CAPA Plans and change controls Ability to simplify complex processes/problems and propose alternate solutions Quality oversight experience with third party/contract manufacturing Demonstrated negotiation and influence skills Demonstrated written, and interpersonal communication, and project management skills Knowledge of radiopharmaceutical manufacturing GMP’s Able to communicate effectively in both written and verbal forms to both internal and external customers
Additional Requirements Ability to travel domestically and internationally from 10-25%, as required.
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