Senior Director, Quality Assurance – Global Affiliates

At Genmab we are dedicated to building extranotordinary 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!

With a growing network of affiliates and partners across Europe North America and Asia-Pacific Genmab operates within a complex multi-jurisdictional regulatory environment. This role ensures that our global footprint maintains the highest standards of quality compliance and operational excellence.

The Senior Director Quality Assurance Global Affiliates plays a pivotal role in leading quality governance across Genmab Affiliates and contributes as a member of the Genmab Quality Leadership Team shaping our quality strategy.

The Role

The Senior Director QA Global Affiliates provides strategic leadership and oversight for Quality Assurance across Genmab Affiliates and Partners. This position ensures all Genmab Affiliates and Partners operate with the highest standards of GxP and GDP compliance while driving system maturity operational consistency and a culture of proactive quality.

You will lead a growing global team to manage quality risks advance system maturity through governance and metrics and partner with senior stakeholders to ensure inspection readiness and continuous improvement across all locations.

Reporting to the Vice President Global Quality and serving as a member of the Genmab Quality Leadership Team this position provides enterprise-level direction for affiliate QA and ensures alignment with Genmabs global quality strategy.

Responsibilities

Strategic Quality Leadership

• Lead the strategic execution of quality assurance across Genmab Affiliates ensuring alignment with corporate quality objectives

• Shape and implement the global affiliate QA strategy with clear performance goals and governance structures

• Collaborate across Global Quality Regulatory Affairs Medical Affairs and Supply Chain to ensure consistency and alignment across quality domains

• Serve as a strategic partner to business and regional leaders embedding quality considerations into operational and strategic decisions

Quality Oversight & Compliance

• Ensure all Genmab Affiliates and third-party entities operate in full compliance with GxP and local health authority regulations maintaining continuous inspection readiness

• In partnership with functional QA teams ensure product quality and safety requirements are met across all markets through aligned quality agreements shared governance and transparent communication

• Oversee partner and third-party QMS adherence ensuring external entities performing activities on behalf of Genmab meet company quality standards and procedures

• Establish and chair affiliate QA governance forums to review performance emerging risks and compliance trends

• Define and monitor key performance indicators and report regularly to the Quality Leadership Team

Quality Leadership Team

• Serve as Genmabs global lead for affiliate audits and inspections ensuring consistent execution tracking and timely closure of findings

Quality Systems & Continuous Improvement

• Ensure the Genmab Quality Management System (QMS) is in effective use across all Genmab Affiliates

• Foster a learning organization across Genmab Affiliates by sharing audit insights regulatory updates and process improvements

Leadership & People Development

• Lead and develop a growing globally distributed QA team empowering Affiliate leads through accountability clarity and a culture of continuous learning

• Foster a culture of accountability inclusion transparency and collaboration

• Empower team members with clear roles responsibilities and development plans that support Genmabs long-term quality objectives

• Promote Genmabs leadership principles and values of integrity determination and teamwork in all QA activities

Stakeholder Engagement & Collaboration

• Partner with global and regional leaders to ensure quality is embedded across all business functions and affiliates operate in alignment with Genmabs quality objectives

• Partner with functional QA leaders to ensure subject-matter expertise is effectively shared with Genmab Affiliates and that market-level insights are captured and communicated ensuring Genmab consistently meets local regulatory requirements

• Collaborate cross-functionally with Regulatory Affairs Medical Affairs and Supply Chain to ensure aligned and compliant processes

• Represent Genmab QA in external forums and regulatory engagements to promote transparency and regulatory trust

• Provide senior management with actionable insights through regular quality performance dashboards and risk reviews

Requirements

• Advanced degree (BSc/MSc/PharmD) in Life Sciences Pharmacy or related field required; MBA or equivalent is an advantage

• Minimum 15 years of experience in Quality Assurance within the biotechnology pharmaceutical or related regulated industries including significant global or regional leadership experience

• Deep knowledge of GMP GDP and GVP regulations and major global health authority expectations (EMA FDA MHRA PMDA Health Canada etc.)

• Proven success in developing implementing and sustaining global QMS frameworks across multiple geographies

• Demonstrated expertise in audits inspections and compliance risk management

• Experience leveraging digital quality systems data analytics and metrics-driven performance management

• Skilled at leading through influence within complex matrixed environments. Excellent communication negotiation and stakeholder-management skills

• Fluent in English

• Strategic and global leadership mindset with a commitment to quality excellence patient focus and compliance integrity

• Strong influencing and relationship management across geographies and cultures

• Skilled at balancing standardization with local regulatory nuances

• Decisive collaborative and results-oriented

• Culturally agile and experienced in leading across diverse teams

About You

• You are genuinely passionate about our purpose

• You bring precision and excellence to all that you do

• You believe in our rooted-in-science approach to problem-solving

• You are a generous collaborator who can work in teams with a broad spectrum of backgrounds

• You take pride in enabling the best work of others on the team

• You can grapple with the unknown and be innovative

• You have experience working in a fast-growing dynamic company (or a strong desire to)

• You work hard and are not afraid to have a little fun while you do so!

Locations

Genmab maximizes the efficiency of an agile working environment when possible for the betterment of employee work-life balance. Our offices are crafted as open community-based spaces that work to connect employees while being immersed in our powerful laboratories. Whether youre in one of our office spaces or working remotely we thrive on connecting with each other to innovate.

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 Genmabs 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.

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