Director QC

EPM Scientific; Lenoir (NC); Vor Ort; USD 150.000 - 210.000; Vollzeit

Zusammenfassung

EPM Scientific is seeking a Director of Quality Control to lead QC operations at a GMP-regulated pharmaceutical site. The role includes guiding analytical chemistry, microbiology, environmental monitoring, stability programs, and release testing while shaping site growth.

The successful candidate will drive lab efficiency, ensure regulatory compliance, mentor a high-performing QC team, and partner with Quality Assurance and Operations to advance strategic goals.

Qualifikationen

• Quality leadership experience in pharmaceutical, biotech, or GMP environments.
• Knowledge of analytical testing, microbiology, stability studies, and lab operations.
• Experience supporting FDA inspections and regulatory compliance.

Aufgaben

• Lead QC operations in a GMP manufacturing environment.
• Provide leadership across analytical, microbiology, environmental monitoring, and stability functions.
• Partner with QA, Manufacturing, Regulatory Affairs, and Technical Operations.
• Oversee laboratory compliance, investigations, CAPAs, and continuous improvement.

Kenntnisse

Quality leadership

GMP knowledge

Analytical testing

Regulatory inspections

Cross-functional collaboration

Ausbildung

Bachelor's degree

Advanced degree preferred

Tools

Lab instrumentation

Jobbeschreibung

A growing pharmaceutical manufacturing organization is seeking a Director of Quality Control to lead QC operations across a GMP-regulated manufacturing site.

This individual will provide leadership for laboratory operations and quality control strategy, overseeing analytical chemistry, microbiology, environmental monitoring, stability programs, and release testing activities while helping drive the next phase of site growth.

Key Responsibilities:

• Lead Quality Control operations in a GMP manufacturing environment
• Provide leadership across analytical, microbiology, environmental monitoring, and stability functions
• Partner closely with Quality Assurance, Manufacturing, Regulatory Affairs, and Technical Operations
• Oversee laboratory compliance, investigations, CAPAs, and continuous improvement initiatives
• Support regulatory inspections and interactions with health authorities
• Develop and mentor a high-performing QC team
• Drive laboratory efficiency, compliance, and operational excellence

Qualifications:

• Bachelor's degree required, advanced degree preferred
• Significant Quality Control leadership experience within pharmaceutical, biotechnology, or related GMP-regulated manufacturing environments
• Strong knowledge of analytical testing, microbiology, stability studies, and laboratory operations
• Experience supporting FDA inspections and regulatory compliance activities
• Proven ability to lead teams and influence cross-functional stakeholders

Why Consider This Opportunity?

• High-impact leadership role
• Visible position with executive-level interaction
• Opportunity to shape the future direction of the Quality Control organization
• Growing manufacturing environment with strong investment and long-term plans