German Affiliate Quality Director & Responsible Person (RP)
- Compensation
- Not disclosed
- Location
- Munich, Bavaria
- Work setup
- Not specified
- Seniority
- Not specified
- Employment
- Contract
- Experience
- 10+ years
- Category
- Not specified
- Posted
Skills
Must have
- 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
- 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 mark
- 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
Nice to have
- Previous experience as a Responsible Person for pharmaceutical wholesale distribution in Germany, Deputy Responsible Person, or substantial relevant experience demonstrating readiness for appointment
- 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 w
Full description
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.
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**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