Affiliate Quality Director & Responsible Person; RP​/RPi

At Genmab, we are dedicated to building extraordinary® 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 UK Affiliate Quality Director is responsible for establishing and maintaining the affiliate Quality Management System and ensuring compliance with UK Good Distribution Practice (GDP), MHRA requirements and Genmab Global Quality standards.

The role holder will be nominated as the Responsible Person (RP & RPi) on the affiliate’s Wholesale Distribution Authorisation WDA(H). The role has no line management responsibilities.

The position leads the UK affiliate Quality function and is embedded in Quality Global Affiliates, working closely with the UK 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.

• Lead the Quality workstream for establishment of the UK affiliate and its wholesale distribution authorisation WDA(H)
• 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 and Commercial functions
• Provide independent Quality advice to UK affiliate leadership and elevate significant compliance risks
• Establish and maintain documented absence and continuity arrangements for RP/RPi duties including suitable cover, handovers, system access and escalation arrangements

• Fulfil the responsibilities of the Responsible Person under applicable UK pharmaceutical legislation
• Establish and maintain a documented system to verify the required QP certification for batches imported from approved countries for import, retaining appropriate evidence
• 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

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

• Manage deviations, CAPAs, change controls and quality risk management activities
• Lead affiliate Quality qualification and ongoing oversight of GxP 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, unresolved compliance issues and resource constraints directly to Quality Global Affiliates leadership and the UK General Manager

• 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…