Remote US Pharma QA Leader - Compliance & Audits

Found Consultancy; Durham (NC); Hybrid; USD 120,000 - 160,000; Full time

Job summary

Found Consultancy is seeking an US Pharmaceutical Quality Assurance Manager to lead quality objectives across US sites, ensure compliance with ISO 9001, CAP, ICH Q1A/Q1B and cGMP, and manage internal and external audits. The role requires strong biotech/pharma QA leadership and cross-site collaboration.

You will oversee e-QMS, CAPA investigations, training, and continuous improvement initiatives, reporting to the Head of Global Quality. Travel across US is involved.

Qualifications

• Degree in Quality, Pharmaceuticals, Biology, Chemistry, life sciences or related engineering subjects.
• Experience in Pharmaceutical Storage supply chain environment.
• Experience with ISO 9001, CAP, ICH Q1A/Q1B, and cGMP.

Responsibilities

• Lead and drive Quality objectives across all US sites, ensuring adherence to procedures, safety standards and regulatory frameworks.
• Oversee regulatory compliance, e-QMS execution, and site-level governance across all US sites.
• Harmonise Global quality policies and procedures across the US sites.
• Oversee planning and scheduling of internal and external audits across US sites.
• Conduct internal audits and ensure effective reporting and trending of findings.
• Ensure staff are trained and competent in e-QMS tasks.
• Implement process improvements and mentor team for continuous improvement.
• Review CAPA/incident related events with root-cause analysis and timely closure.
• Conduct routine site visits to verify process adherence and data accuracy.

Skills

Quality Assurance

Regulatory compliance

Auditing

GxP experience

cGMP / GMP experience

Education

Quality, Pharmaceuticals, Biology, Chemistry, life sciences or related engineering subjects

Job description

Found Consultancy is seeking an US Pharmaceutical Quality Assurance Manager to lead quality objectives across US sites, ensure compliance with ISO 9001, CAP, ICH Q1A/Q1B and cGMP, and manage internal and external audits. The role requires strong biotech/pharma QA leadership and cross-site collaboration.

You will oversee e-QMS, CAPA investigations, training, and continuous improvement initiatives, reporting to the Head of Global Quality. Travel across US is involved.