Quality Systems Lead - cGMP/GLP Compliance & Audits

Merck KGaA; Rockville (MD); On-site; USD 71,000 - 106,000; Full time

Benefits offered by this job

Health insurance

Paid time off

Retirement contributions

Other perquisites

Job summary

Merck KGaA in Rockville, MD is seeking a Quality Specialist 3 to support Contract Testing Services by ensuring cGMP/GLP compliance and regulatory requirements. The role performs document review, investigations, audit support, and CAPA activities.

You will lead root cause analysis, host change control meetings, approve quality records, support regulatory inspections, and contribute to continuous improvement across QA and Operations.

Qualifications

• Bachelor's degree in a related field required.
• 4 years' experience in Quality Assurance within a GxP environment.
• Strong knowledge of cGMP/GLP and regulatory requirements.

Responsibilities

• Author, review and approve controlled quality documents (SOPs, records).
• Review and approve events/deviations and investigations.
• Lead root cause analysis using approved tools.
• Own and review CAPAs and monitor effectiveness.
• Support customer discussions related to investigations and CAPAs.
• Host change control meetings and approve changes.
• Develop training materials and train staff on QMS records.
• Review study documents (protocols, specs, data).
• Host audits and respond to audit findings with follow-ups.
• Support regulatory inspections and readiness.

Skills

Quality Assurance

cGMP knowledge

Communication skills

Regulatory knowledge

Education

Bachelor's Degree

Tools

GxP systems

Audit management software

Job description

Merck KGaA in Rockville, MD is seeking a Quality Specialist 3 to support Contract Testing Services by ensuring cGMP/GLP compliance and regulatory requirements. The role performs document review, investigations, audit support, and CAPA activities.

You will lead root cause analysis, host change control meetings, approve quality records, support regulatory inspections, and contribute to continuous improvement across QA and Operations.