Senior Manager, GCP QA & Audit Strategy

Gan & Lee Pharmaceuticals; Denmark; Hybrid; DKK 900,000 - 1,500,000; Full time

Job summary

Gan & Lee Pharmaceuticals is seeking a Senior Manager, Clinical Quality Assurance to lead GCP audits and QA activities across clinical development programs. You will partner with senior leadership to maintain audit strategies and ensure inspection readiness.

The role requires 5+ years in QA/clinical operations with GCP experience, strong communication, and the ability to travel up to 30%. Based in Denmark or the United States, with a focus on compliant, high-quality trials.

Qualifications

• Bachelor’s degree in Life Sciences or related field.
• Minimum 5 years QA/clinical operations with GCP experience (3 years with advanced degree).
• Experience conducting GCP audits and familiarity with regulatory inspections.

Responsibilities

• Maintain the GCP audit strategy with senior leadership support.
• Plan, conduct, and report vendor, CRO, and site audits per SOPs; support development programs.
• Manage GCP Quality Events, Deviations, and CAPAs; lead SOP reviews and updates.
• Oversee GCP activities including protocol reviews, investigator training, data integrity assessments, and regulatory submissions.
• Contribute to periodic QMS Management Reviews and cross‑functional projects.

Skills

English communication

Team leadership

Project management

Stakeholder collaboration

Education

Bachelor's degree in Life Sciences

Job description

Gan & Lee Pharmaceuticals is seeking a Senior Manager, Clinical Quality Assurance to lead GCP audits and QA activities across clinical development programs. You will partner with senior leadership to maintain audit strategies and ensure inspection readiness.

The role requires 5+ years in QA/clinical operations with GCP experience, strong communication, and the ability to travel up to 30%. Based in Denmark or the United States, with a focus on compliant, high-quality trials.