Director of Quality Control

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

The Director of Quality Control provides strategic and operational leadership for the Quality Control function, including chemical, microbiological, raw-material, in-process, finished-product, environmental-monitoring, and stability testing, as applicable. This leader ensures that laboratory operations, data, methods, specifications, and release-support activities comply with current Good Manufacturing Practice requirements, approved procedures, regulatory commitments, and the company’s pharmaceutical quality system. The Director develops laboratory capability, promotes data integrity and scientific rigor, and partners across the organization to ensure the consistent delivery of safe, effective, and high-quality products.

Essential Duties and Responsibilities

• Set the vision, priorities, operating model, and annual objectives for Quality Control in alignment with site and enterprise quality strategies.
• Lead day-to-day QC laboratory operations and ensure timely, accurate testing of raw materials, components, in-process materials, finished products, stability samples, utilities, and environmental samples, as applicable.
• Ensure laboratory controls, specifications, sampling plans, test methods, documentation, and records meet cGMP requirements and applicable FDA, Health Canada, and internal standards.
• Maintain a strong culture of data integrity, right-first-time execution, scientific judgment, safety, accountability, and continuous improvement.
• Oversee method development, transfer, qualification, validation, verification, and lifecycle maintenance in partnership with Process Development and other technical functions.
• Provide governance for laboratory investigations, including out-of-specification, out-of-trend, atypical, invalid, and deviation events; ensure investigations are timely, scientifically sound, and supported by effective CAPA.
• Monitor stability programs, reference standards, retain samples, laboratory instrumentation, computerized systems, reagents, standards, and sample-management processes.
• Establish and review key performance indicators for quality, compliance, service, capacity, cost, and personnel; identify trends and implement sustainable corrective or preventive actions.
• Ensure the QC function is inspection-ready; host or support regulatory inspections, customer audits, internal audits, and responses to observations or commitments.
• Develop resource, succession, workforce, capital, and operating plans; manage the QC budget and balance laboratory capacity with business demand.
• Select, qualify, and oversee contract laboratories, suppliers, and service providers in collaboration with Quality Assurance and Procurement.
• Recruit, coach, and retain a high-performing team; establish clear expectations, assess performance, build technical and leadership capability, and ensure required training is completed and effective.
• Partner cross functionally to support product release, investigations, change controls, technology transfers, process validation, and new-product introductions.
• Serve as a senior subject-matter expert for laboratory controls and elevate significant quality or compliance risks to site leadership.
• Perform other duties consistent with the scope and level of the position.

Required Qualifications

• Bachelor’s degree in chemistry, biochemistry, microbiology, pharmaceutical sciences, or a related scientific discipline. Masters preferred.
• At least 10 years of progressively responsible experience in pharmaceutical, biotechnology, biologics, or another highly regulated laboratory environment.
• At least 5 years of direct people-leadership experience, including responsibility for managers or multiple laboratory teams.
• Demonstrated knowledge of cGMP laboratory controls, data integrity, analytical methods, stability programs, investigations, CAPA, change control, and inspection readiness.
• Experience with sterile, aseptic, allergenic, biologic, or combination-product operations, as relevant to the site portfolio.
• Experience with laboratory information management systems, chromatography data systems, electronic quality systems, and computerized-system validation.
• Quality, operational-excellence, or project-management certification, such as ASQ, Lean Six Sigma, or PMP.
• Experience interacting with health authorities and leading or supporting regulatory inspections.
• Strong record of applying scientific and risk-based decision-making to complex laboratory and product-quality issues.
• Excellent written, verbal, organizational, and cross-functional leadership skills.
• Build trust through integrity, transparency, sound judgment, and consistent follow-through.
• Sets clear direction, translates strategy into execution, and holds teams accountable for measurable results.
• Develop people through coaching, candid feedback, empowerment, and meaningful growth opportunities.
• Challenges the status quo while protecting product quality, patient safety, and regulatory compliance.