German Affiliate Quality Director & Responsible Person (RP)

Posted 2 days ago

genmabMunich (ND)

Quality Control Systems Managers Biological Product (except Diagnostic) Manufacturing

SENIORITY

Manager

Apply

About the role

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 WDAAct 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
RequiredDegree 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 and follow us on LinkedIn and X. Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website Job Applicant Privacy Notice ().. click apply for full job details

Before you apply

Applying takes about a minute. These four things decide how fast it moves after that.

Your profile is current

It's what we read first. Occupations, seniority and locations matter more than a long history.

Two examples you can talk through

Not a portfolio — just two pieces of work where you can explain the decisions and what you'd change.

A number in mind

What you're on now and what would make you move. We negotiate better when we know both.

Your notice period

Employers plan around it, and it's the question that stalls offers most often.

Once you apply, someone reads it and calls you before anything reaches the employer — usually within two working days.