Associate Director, API Supplier Quality Management
Scorpion Therapeutics, New Philadelphia, Pennsylvania, United States, 17959
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. The role ensures effective management and routine quality oversight of contracted manufacturers, service providers and related suppliers and vendors of materials and components, and provides operational support of commercial QC laboratories.
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
Authorized to work in the United States on a full-time basis
Strong chemistry background in API production
Education
Bachelor’s degree 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 GMPs
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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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
Authorized to work in the United States on a full-time basis
Strong chemistry background in API production
Education
Bachelor’s degree 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 GMPs
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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