QA Director
2 weeks ago
Genmab is a global biotech company dedicated to transforming the lives of patients through innovative cancer treatment.
Salary and BenefitsWe offer a highly competitive salary, ranging from $150,000 to $180,000 annually, depending on experience. Our benefits package includes health insurance, retirement plans, and generous paid time off.
About the RoleThe QA Director will play a critical role in ensuring compliance with industry standards and regulations for Genmab's Late Stage Development products. As GMP QA Associate Director, you will be responsible for setting the quality direction for our team and collaborating with cross-functional partners to achieve business objectives.
- Act as QA responsible for Manufacturing, Process Transfer, Process Validation for Antibody Intermediates, Chemical Intermediate, and Drug Substance ADC.
- Act as QP delegate by releasing Antibody Intermediates, Chemical Intermediates, and Drug Substance ADC for further manufacturing.
- Provide QA oversight of CMOs in relation to outsourced GMP activities, including Audits, Vendor Risk Evaluations, review, and negotiation of Quality Agreements.
To succeed in this role, you will need:
- A MSc degree or equivalent in a relevant life science subject.
- +10 years of experience from the pharmaceutical industry within QA, preferably within biologics and/or chemical intermediate, and/or sterile products.
- Experience working in an EDMS system.
- Excellent communication skills in English, and a collaborative mindset.
At Genmab, we value our employees' well-being and offer a range of benefits, including:
- Flexible work arrangements, including remote work options.
- Opportunities for professional growth and development.
- A diverse and inclusive work environment.
Our offices are designed as open, community-based spaces that foster collaboration and innovation. We leverage the effectiveness of an agile working environment for the betterment of employee work-life balance.
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