Associate Director, QA for QC

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!

The Role

Genmab is expanding its QA for QC team and is seeking a senior QA for QC Specialist GMP QA hired at Associate Director level to support the GMP QC laboratory in Ballerup. The role is a senior individual contributor position with no people or line management responsibilities. Your main place of work will be at the Genmab site in Ballerup.

The QA for QC Specialist will join a small QA for QC team that is part of GMP QA organisation and work closely with QC laboratory staff QC subject matter experts and QC management to ensure appropriate QA oversight of QC activities. The role supports both early-phase clinical development as well as late-phase and commercial activities within antibodies and stability testing.

In this role you will collaborate closely with stakeholders across QC QA Regulatory Affairs and IT/digital functions. The role requires strong influencing skills and the ability to build trust across functions without formal authority.

The QC laboratory in Ballerup supports the organisation with stability studies for both early-phase clinical development as well as late-phase projects as well as selected release testing. Testing is performed on intermediates Drug Substance (DS) and Drug Product (DP).

The laboratory has been in operation a little more than two years and currently employs around 35 employees across analytical and support functions. As a relatively young and growing laboratory the environment is dynamic and continuously evolving with a strong focus on building robust GMP-compliant processes while supporting the organisations needs.

The QA GMP team at Genmab currently employs around 40 people located in Denmark China and US. Our new colleague will report to Team Lead GMP QA for QC.

An exciting job opportunity with responsibilities supporting supply to clinical trials in a company thats driving breakthroughs in cancer immunotherapy.

Key Responsibilities

The responsibilities of the GMP QA Associate Director will include but not be limited to:

• Provide QA oversight of routine GMP QC laboratory activities in Genmabs QC laboratory.

• Promote collaborative relations with relevant internal stakeholders.

• Act as QA reviewer and sparring partner for deviations and laboratory investigations

• Provide QA review and support of equipment life cycle management including qualifications of laboratory equipment

• Act as a constructive QA sparring partner to QC subject matter experts and QC management

• Contribute to QC-related projects and continuous improvement initiatives

• Support digitalization and optimization of QA and QC processes including critical assessment of LIMS usage data flows and segregation of duties

• Support audits of suppliers and contract laboratories as part of audit team or as lead auditor when required

Ways of Working

As QA for QC Specialist you are expected to have a pragmatic approach to the QA role applying science- and risk-based judgement rather than a purely compliance-driven approach. At the same time you should be confident in setting a clear direction for QC lab when needed. You will balance speed quality and compliance in a dynamic environment challenge the status quo constructively and operate comfortably in both early-phase development and late-phase/commercial settings.

You thrive in a fast-paced and sometimes unstructured and a bit hectic environment with many parallel activities and can priorities effectively between core tasks critical cases and improvement initiatives. You work independently with limited day-to-day guidance and are comfortable asking questions when needed.

Skills & Experience

• You hold a MSc degree or equivalent in a relevant life science subject.

• You have solid experience from the pharmaceutical industry preferably working with quality in regulated QC settings before either as QA or QC SME.

• You have a strong understanding of data flows and segregation of duties

• Solid knowledge of GMP regulations and the interpretation for both clinical development and commercial processes.

You preferably have previous work experience with one or more of the following:

• Analytical methods in Early-phase clinical development

• Analytical method validations preferably within biologics

• Supporting implementation of digital systems e.g. LIMS or similar

• Working with continuous improvements in a structured manner

• Working as a Lead auditor

Strong English communication skills are required. The ability to work effectively in a multicultural environment is expected.

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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