Senior Manager, QA GDP — Global Audits & Compliance

Genmab; København; Vor Ort; DKK 608.000 - 912.000; Vollzeit

Benefits dieser Stelle

Pension

Health insurance and wellness benefits

Paid time off

Employee support programs

Zusammenfassung

Genmab is seeking a Senior Manager, QA GDP to join the Denmark-based team. You will lead GxP audits of external vendors, oversee GDP quality activities, and partner with QA, Supply Chain and Commercial Operations to ensure compliant distribution.

You will travel about 50% internationally, contribute to quality systems and support inspections while acting as a respected SME across global projects, driving risk-based decisions and continuous improvement.

Qualifikationen

• Bachelor’s or master’s degree in science or related field.
• 8+ years of experience within pharma/biotech with QA and GxP.
• Audit experience is required, with GDP and commercial distribution knowledge preferred.
• Proactive, ownership-driven, and able to navigate new areas independently.
• Strong interpersonal skills and ability to build cross-functional relationships.
• Fluent in English and able to communicate confidently in a multinational environment.

Aufgaben

• Plan and conduct GxP audits of external vendors and partners and contribute to audit planning, follow-up and continuous improvement based on audit observations and trends.
• Take ownership of vendor oversight activities, including vendor risk evaluations, quality agreements and follow-up on performance and compliance of GDP vendors.
• Independently manage operational GDP quality activities, including external notifications, change controls, deviations and other quality issues involving external partners.
• Participate in and support recall operations for the EU market in collaboration with the global QA GMP team and external partners.
• Contribute to shipping lane validation/qualification and perform GDP risk assessments related to storage, transportation and supply chain operations.
• Contribute to the implementation and continuous improvement of quality systems, SOPs and work instructions.
• Represent QA GDP in cross-functional and global projects, taking ownership of QA deliverables within assigned areas.
• Perform shipment release and support EU serialization activities.
• Support implementation and maintenance of GDP training.
• Participate in regulatory inspections and internal audits.
• Maintain knowledge of new and updated GDP regulations and guidelines and translate relevant requirements into practice.
• Collaborate closely with Supply Chain, Commercial Operations and other stakeholders to ensure compliant distribution practices.
• Handle and contribute to continuous improvement of Product Complaint intake and investigations.
• Take on new quality topics and assignments as business needs evolve, independently building the knowledge and stakeholder network needed to bring activities forward.

Kenntnisse

GxP audits

Quality Assurance

Auditing

Regulatory awareness

English communication

Stakeholder management

Ausbildung

Bachelor’s or Master’s degree in science

Jobbeschreibung

Genmab is seeking a Senior Manager, QA GDP to join the Denmark-based team. You will lead GxP audits of external vendors, oversee GDP quality activities, and partner with QA, Supply Chain and Commercial Operations to ensure compliant distribution.

You will travel about 50% internationally, contribute to quality systems and support inspections while acting as a respected SME across global projects, driving risk-based decisions and continuous improvement.