Senior Clinical Supplies Quality Lead

MSD; West Point (PA); Híbrido; USD 106.000 - 167.000; Jornada completa

Descripción de la vacante

MSD is seeking a Senior Specialist, Clinical Supplies Quality to support the Clinical Supply Chain for development programs, ensuring reliable clinical supply availability, quality, and regulatory compliance. The role covers US quality operations, disposition, global distribution planning, and integration activities.

You will collaborate with Global Clinical Supplies, Regulatory Affairs, Device Development, External partners, and Clinical Trial Operations to prevent supply disruption and drive

Formación

• Bachelor’s Degree in Scientific Discipline with 5+ years in pharma/GMP settings or advanced degree with 6+ years of relevant experience.
• Familiarity with batch disposition (release) activities.
• Experience reviewing and approving investigations, deviation management support, and CAPAs.
• In-depth working knowledge of cGMPs and regulatory requirements as they apply to pharma.
• Evidence of leadership with strong oral and written communication skills.
• Demonstrated teamwork and collaboration across cross-functional teams.

Responsabilidades

• Provide in-depth technical and quality expertise on clinical supply operations, medical devices/combination products, and new technologies.
• Develop and execute quality and stakeholder strategies; drive process improvements leveraging technology.
• Evaluate and disposition Clinical Supply materials to ensure conformance with policies and regulations.
• Coordinate or support investigations, deviations, and significant quality events.
• Identify trends and potential compliance gaps; lead resolution of issues affecting quality and reliability of clinical supply chain.

Conocimientos

Clinical supplies

Regulatory compliance

Stakeholder management

Continuous improvement

Leadership

R&D collaboration

Educación

Bachelor’s Degree in Scientific Discipline

Advanced Degree in related field

Herramientas

ERP/MES

Trackwise

SAP

PowerPoint

Excel

Word

Descripción del empleo

MSD is seeking a Senior Specialist, Clinical Supplies Quality to support the Clinical Supply Chain for development programs, ensuring reliable clinical supply availability, quality, and regulatory compliance. The role covers US quality operations, disposition, global distribution planning, and integration activities.

You will collaborate with Global Clinical Supplies, Regulatory Affairs, Device Development, External partners, and Clinical Trial Operations to prevent supply disruption and drive