Associate Director - QA GMP

4d4 days ago

Genmab

Copenhagen, DK · Full-time · DKK 850,000 – DKK 1,200,000

About this role

At Genmab, we are dedicated to building extraordinary futures by developing antibody products and groundbreaking medicines that change lives and the future of cancer treatment. We strive to create a workplace where unique contributions drive innovative solutions for patients and employees.

The Associate Director provides strategic and operational Quality Assurance oversight of development-stage manufacturing activities supporting clinical trials through external manufacturing partners. This ensures product quality, patient safety, and reliable supply within the outsourced network.

You will become part of Genmab’s global GMP QA organization with over 50 GXP professionals across multiple countries. The position is based in Denmark and reports to the Director of GMP QA Development for Drug Product and Clinical Supply.

Working closely with CMOs and cross-functional stakeholders, you will maintain a strong quality culture and ensure compliance with GMP requirements throughout the development lifecycle. This role supports development programs for drug product and investigational medicinal products.

Requirements

Experience providing QA oversight of drug product and clinical supply manufacturing
Knowledge of GMP requirements throughout the development lifecycle
Ability to act as QP delegate for DP and IMP
Experience performing and following up on CMO audits
Proficiency in batch documentation review and batch disposition decisions
Capability to support regulatory inspections and internal audits

Responsibilities

Provide end-to-end QA oversight of DP and IMP manufacturing activities at CMOs ensuring GMP compliance and supply continuity
Act as a QP delegate for DP and IMP
Maintain independent, documented, and risk-based decision-making for batch disposition
Oversee Supplier and Contract Manufacturing Organisations (CMOs)
Plan, perform, and follow up on audits of CMOs and critical suppliers
Ensure batch release within delegated authority in accordance with applicable GMP legislation
Serve as a role model and mentor guiding less experienced colleagues
Ensure development-stage batches comply with approved specifications and regulatory requirements prior to disposition

Benefits

Part of a global GMP QA organization spanning Denmark, the Netherlands, the US, Japan, and China
Opportunity to support development programs within a fully outsourced manufacturing network