Associate Director, Clinical Supply Quality & Strategy

MSD; Pennsylvania; Hybrid; USD 129.000 - 203.000; Vollzeit

Benefits dieser Stelle

Hybrid work model

Competitive benefits

Zusammenfassung

Merck & Co., Inc. seeks an Associate Director, Clinical Supplies Quality to provide strategic quality leadership for global development activities.

This role ensures clinical supplies are compliant, available, and fit for use across programs, coordinating with Global Development Quality, Regulatory Affairs, and external partners. The position requires strong cGMP knowledge, cross-functional collaboration, and leadership of complex quality initiatives, with a hybrid work model in Pennsylvania.

Qualifikationen

• Bachelor’s degree in scientific discipline with GMP/Pharma exposure.
• 8+ years of relevant pharma/ GMP experience or advanced degree with 6+ years of experience.
• Experience with Medical Device/Combination Products and regulatory expectations.

Aufgaben

• Provide quality oversight for Clinical Supply Chain activities across development programs.
• Lead investigations related to deviations and quality events; manage disposition.
• Identify trends and risks; drive remediation and continuous improvement across QA and supply chain.

Kenntnisse

Deviation Management

Process Implementations

Product Compliance

Project Leadership

Project Risk Assessments

Quality Oversight

Quality Risk Management

Regulatory Compliance

Stakeholder Management

Standards Compliance

Strategic Leadership

Strategy Development

Ausbildung

Bachelor’s Degree in Scientific Discipline

Advanced Degree

Jobbeschreibung

Merck & Co., Inc. seeks an Associate Director, Clinical Supplies Quality to provide strategic quality leadership for global development activities.

This role ensures clinical supplies are compliant, available, and fit for use across programs, coordinating with Global Development Quality, Regulatory Affairs, and external partners. The position requires strong cGMP knowledge, cross-functional collaboration, and leadership of complex quality initiatives, with a hybrid work model in Pennsylvania.