Director of Quality Control & Compliance

Stallergenes Greer U.S.; Lenoir (NC); On-site; USD 150,000 - 210,000; Full time

Job summary

Stallergenes Greer U.S. seeks a Director of Quality Control to lead QC operations across chemical, microbiological, raw-material, in-process, finished-product, environmental monitoring, and stability testing. You will ensure cGMP compliance, robust data integrity, and audit readiness while guiding strategy and the QC budget.

You will collaborate with Process Development and QA to build capability, drive continuous improvement, and safeguard product safety and quality for patients at the site.

Qualifications

• Bachelor’s degree in a relevant science with minimum 10 years in regulated labs.
• At least 5 years of direct people-leadership experience overseeing multiple teams.
• Strong knowledge of cGMP, data integrity, investigations, CAPA, and change control.
• Experience with sterile, allergenic, biologic, or combination-product operations.
• Experience with laboratory information management systems and validation processes.
• Quality certifications such as ASQ, Lean Six Sigma, or PMP are preferred.
• Experience with regulatory inspections and health-authority interactions.
• Proven ability to apply risk-based decision making to complex QC issues.

Responsibilities

• Set vision and annual objectives for Quality Control aligned with site strategies.
• Lead day-to-day QC operations and ensure timely, accurate testing across materials and products.
• Ensure labs meet cGMP requirements, documentation, and records standards.
• Maintain data integrity, right-first-time execution, and scientific judgment.
• Oversee method development, transfer, validation, and lifecycle maintenance.
• Provide governance for investigations and CAPA; ensure timely closure.
• Monitor stability programs, reference standards, and instrumentation.
• Establish KPIs and drive continuous improvement and capacity management.
• Prepare for inspections and respond to observations with commitment to compliance.
• Develop resources, succession plans, and budget for QC; manage external labs as needed.
• Partner with QA, Process Development, and Procurement on tech transfers and releases.

Skills

People leadership

cGMP knowledge

Data integrity

Analytical methods

Stability programs

CAPA

Change control

Inspection readiness

Regulatory inspections

LIMS / CDS

Project management

Cross-functional leadership

Risk-based decision making

Education

Bachelor’s degree in chemistry/biochemistry/microbiology/pharmaceutical sciences

Master’s degree preferred

Quality certification (ASQ/Lean Six Sigma/PMP)

Tools

LIMS

Chromatography data systems

Electronic quality systems

Computerized-system validation

Job description

Stallergenes Greer U.S. seeks a Director of Quality Control to lead QC operations across chemical, microbiological, raw-material, in-process, finished-product, environmental monitoring, and stability testing. You will ensure cGMP compliance, robust data integrity, and audit readiness while guiding strategy and the QC budget.

You will collaborate with Process Development and QA to build capability, drive continuous improvement, and safeguard product safety and quality for patients at the site.