US Quality Leader: GMP, FDA Compliance & QMS

Alliance Pharmaceuticals Limited; Cary (NC); Hybrid; USD 90,000 - 120,000; Full time

Job summary

Alliance Pharmaceuticals Limited is seeking a Quality Manager US based in Cary, North Carolina. This key role involves managing quality assurance activities to ensure compliance with regulations and company policies.

The ideal candidate will have extensive experience in FDA-regulated industries, possess strong knowledge of GMPs, and excel in stakeholder management to ensure quality and compliance strategies are effectively implemented.

Qualifications

• 8-10 years’ experience in Quality Assurance or compliance functions in FDA-regulated industry.
• Qualified ISO 13485 auditor desirable.
• Proven interaction with FDA and understanding of GMPs.

Responsibilities

• Lead regional Quality and Technical activities to ensure compliance.
• Manage internal and external stakeholders for business requirements.
• Drive best practices and process improvements in Quality.

Skills

Quality Assurance

Compliance Management

Effective Communication

FDA Regulations

GMP Understanding

Education

Bachelor’s degree in biological, chemical or physical sciences

Job description

Alliance Pharmaceuticals Limited is seeking a Quality Manager US based in Cary, North Carolina. This key role involves managing quality assurance activities to ensure compliance with regulations and company policies.

The ideal candidate will have extensive experience in FDA-regulated industries, possess strong knowledge of GMPs, and excel in stakeholder management to ensure quality and compliance strategies are effectively implemented.