Senior QA Manager: GLP/GCP Audit & Compliance Lead

Zealand Pharma; Søborg; On-site; DKK 900,000 - 1,300,000; Full time

Job summary

Zealand Pharma is seeking a Senior QA Manager, GLP & GCP, to lead GLP QA across non-clinical development and grow into GCP quality oversight. The role covers audits of CROs and laboratories, with hands-on QA, data integrity checks, and cross-functional collaboration in a fast-paced biotech setting.

You will work with the R&D QA team to ensure inspection readiness, quality event management, and ongoing improvement across GLP and expanding GxP expertise.

Qualifications

• Solid, hands-on GLP auditing experience — study audits, facility audits, data reviews.
• Familiarity with OECD GLP Principles and/or FDA 21 CFR Part 58.
• GCP experience in QA or clinical trials is advantageous.
• Experience managing quality events, deviations, CAPAs, and change control.
• Experience supporting regulatory inspections is advantageous.

Responsibilities

• Plan and execute risk-based GLP audit program across QA for CRO labs.
• Conduct and report GLP audits at contract research laboratories.
• Support GCP audits as you build expertise in clinical QA.
• Advise clinical trial teams on protocol compliance and oversight of service providers.
• Manage quality events from GCP activities and drive root cause analysis.
• Establish QA relationships and oversight plans with service providers.

Skills

GLP auditing

GCP knowledge

Quality events management

Regulatory inspections experience

Cross-functional collaboration

Tools

21 CFR Part 11

ICH E6(R3)

GAMP5

Job description

Zealand Pharma is seeking a Senior QA Manager, GLP & GCP, to lead GLP QA across non-clinical development and grow into GCP quality oversight. The role covers audits of CROs and laboratories, with hands-on QA, data integrity checks, and cross-functional collaboration in a fast-paced biotech setting.

You will work with the R&D QA team to ensure inspection readiness, quality event management, and ongoing improvement across GLP and expanding GxP expertise.