Senior QC Operations Leader – Startup Readiness

MSD; Wilmington (DE); On-site; USD 190,000 - 260,000; Full time

Job summary

MSD in Wilmington is seeking a Quality Control Associate Director – Operational Readiness to lead the QC laboratory startup and transition to routine operations. You will coordinate cross-functional teams in Quality, Manufacturing, R&D, IT, and Supply Chain to deliver readiness milestones.

The role requires strong leadership, GMP knowledge, and a track record of implementing robust document control, SOPs, and training programs to ensure inspection readiness and continual improvement.

Qualifications

• Bachelor’s degree in Chemistry, Biochemistry, Engineering, or a related scientific discipline is required; advanced degree preferred.
• Demonstrated leadership in laboratory operations, start-up, or major capital projects.
• Experience with GMP, data integrity, quality systems, and regulatory readiness.

Responsibilities

• Lead end-to-end QC laboratory operational readiness strategy and execution.
• Develop and governance of readiness schedule across multiple workstreams.
• Ensure inspection readiness and regulatory alignment across FDA/EMA expectations.

Skills

Analytical Method Development

Data Integrity

Cross-Functional Leadership

Project Management

Education

Bachelor's degree in Chemistry, Biochemistry, Engineering, or related

Tools

LIMS

SAP

Empower

Veeva

Kneat

MODA

Job description

MSD in Wilmington is seeking a Quality Control Associate Director – Operational Readiness to lead the QC laboratory startup and transition to routine operations. You will coordinate cross-functional teams in Quality, Manufacturing, R&D, IT, and Supply Chain to deliver readiness milestones.

The role requires strong leadership, GMP knowledge, and a track record of implementing robust document control, SOPs, and training programs to ensure inspection readiness and continual improvement.