Associate Director, GCP Inspection Office, R&D Quality

Genmab; Princeton (NJ); On-site; USD 156,000 - 234,000; Full time

Benefits offered by this job

401(k) Plan with 100% match up to 6%

Health, dental and vision insurance

Voluntary plans: critical illness, etc

Paid vacation, sick leave, holidays, 2

Parental leave and wellness programs

Job summary

Genmab seeks a senior GCP Inspection Office lead to drive day-to-day GCP Quality activities and oversee inspection readiness across global clinical programs. You will collaborate with multiple QA and study teams to ensure compliant processes and timely regulatory responses.

The role requires in-depth knowledge of EMA, FDA and PMDA expectations, with proven leadership in inspections and the ability to educate others in GCP practices. A dynamic, international environment awaits.

Qualifications

• 10+ years of experience in a GCP Quality function or similar.
• Deep expertise in GCP processes and the EMA, PMDA and FDA requirements.
• Demonstrated leadership in regulatory inspections and health authority interactions.
• Experience as Lead Auditor within GCP is an advantage

Responsibilities

• Report to Director and Team Lead Inspection Office R&D Quality.
• Oversee GCP inspection readiness across cross-functional clinical study teams.
• Lead end-to-end inspection planning and execution including logistics and stakeholder coordination.
• Lead mock inspections for high-risk trials across Genmab locations.
• Coordinate inspection requests to SMEs and guide timely, effective responses.
• Create and revise tools and SOPs for inspection readiness and management.
• Ensure Veeva records are updated for inspection documentation.

Skills

GCP Quality

Lead Auditor

Regulatory inspections

GCP processes

Education

MS/BS in Natural Science

Job 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!

R&D Quality encompasses four teams GCLP/GLP Quality, PV Quality, Audit Calibration, Quality and GCP Quality. R&D Quality has a large range of stakeholders, and we have an important role in delivering our 2030 vision to transform the future of cancer treatment.

In the role as AD GCP Inspection Office you will be driving day-to-day GCP Quality activities including audit together with a dedicated and highly skilled team. Furthermore, you will be taking up the role as GCP Inspection QA lead.

The role requires profound understanding of how the GCP requirements are applied into practice, especially with focus on the European requirements and interpretation of ICH GCP R3 and Computerized Systems in Clinical Trials.

The role includes hands on GCP Quality activities such as support to our many stakeholders as well as performing audits alone or together with own team members or with support from neighbouring teams. You become a key member of the R&D Quality leadership team that together drives people engagement, setting strategies and ensuring R&D Quality deliverables.

The role requires strong collaboration capabilities in an international setting across various QA departments as well across the company with target stakeholders such as Clinical Trial Operations, Clinical Data, Integration & Reporting, Digital Development, Medical, GDS&PV, and Regulatory Affairs.

Key Responsibilities

• Reporting to Director and Team Lead Inspection Office R&D Quality
• It will ensure GCP inspection readiness across cross functional clinical -study team.
• The role oversees end-of-end inspection planning and execution including logistics and stakeholder coordination.
• Lead and oversee GCP inspection readiness/preparation activities and serve as an inspection lead for regulatory health authority inspection including but not limited to US FDA, MHRA, EMA, CFDI, PMDA etc.
• Collaborate with the cross functional clinical study teams to develop and execute and integrated risk-based inspection readiness/preparation strategy ensuring consistent alignment across functions.
• Manage end to end inspection readiness/preparation activities, including development and maintenance of inspection storyboards with the SMEs, proactive identification and mitigation of the inspection related risk and planning, facilitation.
• Lead the mock inspections for high-risk trials across Genmab locations.
• During the inspection coordinate and assign inspection requests to appropriate SMEs providing oversight and appropriate SME, also guide to ensure timely and effective responses.
• Create/revise appropriate tools / SOPs for inspection readiness/preparation and management.
• Ensure Veeva records are updated for inspection records or related records.
• Demonstrate ability to solve complex problems requiring in-depth evaluation of various factors.
• Fulfill inspection commitments and respond to the inspection and carry out post inspection activities.
• Maintain a central repository of global inspection status and updates
• Meticulous attention to detail, excellent review skills and ability to independently manage multiple tasks in a fast-paced environment.
• Support/manage site inspection in collaboration with GCP Quality.
• Lead and facilitate post-inspection lessons learned session to trends, share best practices and drive sustainable process improvements.

Requirements

• MS, or BS or similar in Natural Science
• 10+ years of experience in a GCP Quality function or similar
• Deep expertise in GCP processes and the EMA, PMDA and FDA requirements.
• Demonstrated leadership in regulatory inspections and health authority interactions.
• Considered to be a Domain Expert within GCP by peers with a strong interest and ability to educate others
• Experience as Lead Auditor within GCP is an advantage

For US based candidates, the proposed salary band for this position is as follows:

$156,000.00---$234,000.00

The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as discretionary bonuses and long-term incentives.

When You Join Genmab, You’re Joining a Culture That Supports Your Physical, Financial, Social, And Emotional Wellness. Within The First Year, Regular Full-time U.S. Employees Are Eligible For

• 401(k) Plan: 100% match on the first 6% of contributions
• Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance
• Voluntary Plans: Critical illness, accident, and hospital indemnity insurance
• Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave
• Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being support
• Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses

Further details on eligibility for compensation and benefits based on role 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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Please note that if you are applying for a position in the Netherlands, Genmab’s policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.