Clinical Supplies QA Lead - Hybrid, Global Development

Regulatory Toolkit; Pennsylvania; Hybrid; USD 106,000 - 167,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) plan

Paid time off

Job summary

Merck & Co., Inc. seeks a Senior Specialist, Clinical Supplies Quality for Global Development Quality to ensure reliable clinical supply availability, quality, and regulatory compliance across clinical programs.

The role partners with Global Clinical Supplies, Regulatory Affairs, Device Development, and External Manufacturing to prevent disruptions in the development portfolio. The candidate will lead quality strategies, manage deviations and CAPAs, and drive continuous improvement in a highly

Qualifications

• Bachelors in a scientific discipline with relevant pharma/GMP experience, or advanced degree with additional years in the field.
• Familiarity with batch disposition (release) activities.
• Experience reviewing investigations, deviation support, and CAPAs.
• In-depth knowledge of cGMPs and regulatory requirements in pharma or related fields.
• Strong communication, leadership, and teamwork skills.

Responsibilities

• Collaborate with Global Clinical Supplies, Global Development Quality, Regulatory Affairs, and other functions to protect the clinical supply chain.
• Develop and execute quality and stakeholder strategies, driving improvement initiatives while leveraging technology.
• Evaluate and disposition clinical supply materials in conformance with policies and regulations.
• Coordinate and/or support investigations of deviations and significant quality events.
• Identify trends and resolve significant quality issues to ensure reliable clinical supply.

Skills

Clinical supply operations

Medical Device/Combination Products

Regulatory compliance (cGMP)

Stakeholder management

Process improvement

Cross-functional leadership

Education

Bachelor's Degree in Scientific Discipline

5+ years GMP/pharma experience

Tools

ERP/MES

Trackwise

SAP

PowerPoint

Excel

Job description

Merck & Co., Inc. seeks a Senior Specialist, Clinical Supplies Quality for Global Development Quality to ensure reliable clinical supply availability, quality, and regulatory compliance across clinical programs.

The role partners with Global Clinical Supplies, Regulatory Affairs, Device Development, and External Manufacturing to prevent disruptions in the development portfolio. The candidate will lead quality strategies, manage deviations and CAPAs, and drive continuous improvement in a highly