Director, CMC GxP Process Excellence

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

In support of Genmab's continued growth, we are seeking a Director, CMC GxP Process Excellence, covering CMC Development & Manufacturing, CMC ADC (China), and Global Supply Chain. In this new role, the Director will be accountable for the effective operation and continued improvement of relevant GxP procedures and processes ensuring that they support the business areas, while meeting Genmab GxP requirements globally.

The position combines GxP process excellence and compliance with hands-on operational leadership working in close partnership with Quality Assurance (QA) to ensure consistent and streamlined operation, implementation, and interpretation of regulatory standards in all business areas. The position will report to the SVP, CMC Development & Manufacturing, and will lead a small GxP Process Excellence team currently consisting of two team members covering Compliance and Training & Documentation respectively.

Key Responsibilities

• Establish and own CMC GxP Process Excellence and ensure alignment with Genmab's company goals and Global Quality System

• Drive GxP Process Excellence compliance from a business area perspective, including follow-up on deviations, CAPAs, change control, and risk management

• Support maintenance of a lean, fit-for-purpose SOP landscape together with Senior Leaders and Quality Assurance counterparts ensuring clarity, usability, and lifecycle management

• Drive continuous improvement initiatives to simplify, harmonize, and scale quality processes and quality risk management approaches

• Act as the CMC GxP process integrator across CMC Development & Manufacturing, CMC ADC (China), and Global Supply Chain across sites in DK, NL, the US and China

• Operate in a strong business partnership with QA, ensuring clear role separation between Quality Assurance oversight and execution within the Technical Operations business areas

• Partner closely with Quality Assurance (QA) to ensure alignment on regulatory standards, compliance expectations, and emerging quality regulations

• Support internal audits, inspections, and inspection readiness

• Support the governance and maintenance/changes of the TechOps GxP systems, and CMC systems e.g. IRT system and the Stability database

• Responsible for assignment of role specific GxP training to employees in the business areas, some compliance related training activities, and documentation handling

Requirements

• Advanced degree in Life Sciences or related field

• Strong hands-on experience with QMS processes in clinical and/or commercial settings

• At least 5 years' experience working with Process Excellence in a GxP context

• Experience from Quality Operations / Quality Systems in Biotech/Pharma is an advantage

• Proven ability to lead cross-functional initiatives and work effectively with QA

• People management experience is an advantage

• Excellent written and verbal communication skills in English

About you

• You are pro-active, take initiative and responsibility

• You drive continuous improvement initiatives and identify opportunities for innovation and optimization

• You are good at prioritizing and focused on achieving goals that are important for the team and our organization

• You work successfully under pressure in a fast-paced environment with tight timelines

• You are a team player with demonstrated ability to collaborate with a diverse group of internal and external stakeholders

• You have a positive attitude, have a strong understanding of cultural differences, and enjoy driving activities as part of international teams

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

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

In addition to base salary, this position is eligible to 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 compensation and benefits 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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