Senior Clinical Supplies Quality Lead (Hybrid)

Merck & Co.; West Point (PA); Hybrid; USD 106.000 - 167.000; Vollzeit

Zusammenfassung

Merck & Co. in Pennsylvania (West Point) seeks a Senior Specialist, Clinical Supplies Quality to support the clinical supply chain, ensuring availability, quality and regulatory compliance of clinical materials for development programs.

The role requires collaboration across Global Clinical Supplies, Regulatory Affairs, Device Development & Technology, and External Development & Manufacturing to prevent disruptions and drive quality improvements.

Qualifikationen

• Bachelor's Degree in Scientific Discipline with 5+ years in pharma/GMP, or advanced degree with 6+ years.
• Familiarity with batch disposition (release) activities.
• Experience reviewing investigations, deviation management support, and CAPAs.
• In-depth knowledge of cGMPs and regulatory requirements in pharma or related field.
• Evidence of leadership, with strong oral and written communication skills.
• Demonstrated teamwork skills and collaboration.

Aufgaben

• Collaborate with Global Clinical Supplies, Regulatory Affairs, Device Development & Technology, and External Development & Manufacturing.
• Navigate high visibility situations to prevent disruption of the clinical development portfolio.
• Provide technical and quality expertise on clinical supply operations and new technologies.
• Develop and execute quality strategies and improvement initiatives.
• Evaluate and disposition clinical supply materials ensuring conformity to policies and regulations.
• Coordinate investigations of deviations and quality events and drive issue resolution.
• Identify trends and proactively address compliance gaps affecting quality.

Kenntnisse

CAPA Management

Detail-Oriented

Deviation Management

Medical Devices

Process Improvements

Quality Risk Management

Six Sigma

Teamwork

Ausbildung

Bachelor's Degree in Scientific Discipline

Advanced Degree in related field

Tools

ERP/MES

Trackwise

SAP

PowerPoint

Excel

Word

Jobbeschreibung

Merck & Co. in Pennsylvania (West Point) seeks a Senior Specialist, Clinical Supplies Quality to support the clinical supply chain, ensuring availability, quality and regulatory compliance of clinical materials for development programs.

The role requires collaboration across Global Clinical Supplies, Regulatory Affairs, Device Development & Technology, and External Development & Manufacturing to prevent disruptions and drive quality improvements.