German Affiliate Quality Director & Responsible Person (RP)

At Genmab, we are dedicated to building extra[not]ordinary® futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines® that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals’ unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees.

Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so.

Does this inspire you and feel like a fit? Then we would love to have you join us!

The Role

The German Affiliate Quality Director is responsible for establishing and maintaining the affiliate Quality Management System and ensuring compliance with applicable German and EU Good Distribution Practice (GDP) requirements as well as Genmab Global Quality standards.

The role holder will be nominated as the Responsible Person (Verantwortliche Person) for the German affiliate's wholesale distribution authorisation (Großhandelserlaubnis) in accordance with the German Medicinal Products Act. The role has no line management responsibility.

The position leads the German affiliate Quality function and is embedded in Quality Global Affiliates, working closely with the German General Manager and relevant global functions. The role combines strategic Quality leadership with hands-on responsibility for affiliate establishment, launch readiness and ongoing operations, exercising independent Quality judgement and the authority necessary to fulfil the designated statutory responsibilities.

Responsibilities
Affiliate Establishment and Collaboration

• Lead the Quality workstream for establishment of the German affiliate and its wholesale distribution authorisation (Großhandelserlaubnis)
• Ensure that the QMS, procedures, training, quality agreements, risk assessments and supply-chain controls are operational before commercial launch
• Partner with Global Quality, Supply Chain, Regulatory Affairs, Pharmacovigilance, Medical, Commercial and other relevant functions
• Provide independent Quality advice to German affiliate leadership and escalate significant compliance risks
• Establish and maintain documented absence and continuity arrangements for RP duties including suitable cover, handovers, system access and escalation arrangements

Responsible Person and Regulatory Compliance

• Fulfil the responsibilities of the Responsible Person under applicable German pharmaceutical legislation and the EU GDP Guidelines
• Ensure that authorised wholesale distribution activities remain within the scope of the WDA
• Act as the primary affiliate contact for GDP-related regulatory inspections and authority interactions, coordinating required notifications and responses with relevant functions
• Exercise independent authority to place products on Quality hold, prevent supply or suspend distribution activities where product quality, patient safety or regulatory compliance may be compromised

Quality Management System

• Establish and maintain the Genmab Germany Affiliate Quality Management System
• Implement applicable Global Quality procedures and develop local procedures where required
• Support continuous improvement of affiliate Quality processes.

Quality Operations

• Manage deviations, CAPAs, change controls and quality risk-management activities
• Lead affiliate Quality qualification and ongoing oversight of GDP-relevant service providers, coordinating with global supplier owners and specialist functions
• Maintain effective document control, training, data integrity and management-review processes
• Establish and maintain a risk-based GDP self-inspection programme
• Escalate significant Quality risks, resource constraints and unresolved compliance issues directly to Quality Global Affiliates leadership and the German General Manager

Distribution and Supply-Chain Quality

• Ensure effective handling of product quality complaints, temperature excursions and distribution incidents, involving Global Quality and relevant product experts
• Decide on the disposition of returned, rejected, recalled or falsified products within the RP remit, including approval of eligible returns to saleable stock
• Maintain effective recall arrangements and coordinate timely local execution with Global Quality, relevant functions and distribution partners
• Ensure effective product traceability, stock status controls and applicable safety feature verification processes across outsourced distribution activities
• Approve and periodically verify suppliers, customers, third-party logistics providers and transport providers
• Approve GDP-relevant outsourced activities and associated Quality or Technical Agreements

Requirements
Required

• Degree in pharmacy, pharmaceutical sciences, life sciences, or a related discipline
• Appropriate training and experience to meet the requirements for appointment as the Responsible Person (Verantwortliche Person) for pharmaceutical wholesale distribution in Germany
• Approximately 10+ years of progressive pharmaceutical Quality experience, including substantial hands-on GDP experience within the German and/or EU medicines supply chain and experience operating at a senior level of Quality responsibility
• Strong working knowledge of EU GDP requirements and applicable German pharmaceutical legislation, with demonstrated experience applying these requirements in pharmaceutical Quality operations
• Practical experience with pharmaceutical distribution and cross-border supply activities, including the Quality and regulatory requirements applicable to medicinal products supplied to the German market
• Experience providing Quality oversight of outsourced logistics, warehousing, transportation, and temperature-controlled/cold-chain operations
• Professional proficiency in German and English, both written and spoken, with the ability to communicate effectively with local regulatory authorities and across global and local stakeholders
• Listed/authorized in Munich

Preferred

• Previous experience as a Responsible Person for pharmaceutical wholesale distribution in Germany, Deputy Responsible Person, or substantial relevant experience demonstrating readiness for appointment as the Responsible Person
• Demonstrated experience establishing, implementing, or maintaining a pharmaceutical QMS, including preparation for and participation in regulatory inspections
• Demonstrated ability to operate as the senior Quality representative for an affiliate, providing independent Quality advice, making risk-based Quality decisions, and exercising appropriate authority within a global matrix organization

Reporting Relationships

• Reports to: Senior Director, Quality Global Affiliates
• Works closely with the German Affiliate General Manager, with direct access for Quality, compliance and resource matters
• Location: Germany (Munich), with travel to logistics providers and licensed or contracted sites as required

The proposed gross annual base salary range for this position, in the primary location, based on a full time schedule is:

EUR97.600,00---146.400,00

The final salary offer will depend on several factors, including your skills, qualifications, and experience.

In addition to base salary, this position is eligible for additional forms of compensation, such as discretionary bonuses and long-term incentives.

When you join Genmab, you become a part of a culture that supports your physical, financial, social, and emotional well-being. Our benefits include, but are not limited to:

• Pension
• Health insurance and wellness benefits
• Paid time off
• Employee support programs

Further details on eligibility for compensation and benefits based on the role will be provided during the recruitment process.

About Genmab

Genmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab’s vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO®) antibody medicines.

Established in 1999, Genmab is headquartered in Copenhagen, Denmark with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X .

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