Senior Manager, GMP Global QA
Are you ready to uplevel your career? Join an innovative biopharmaceutical company and be part of our exciting journey!
We are looking for a Senior Manager, GMP Global QA to join our Global QA team.
Working with Us
At Y-mAbs Therapeutics (NASDAQ: YMAB), our mission is to become the world leader in developing better and safer radioimmunotherapy and antibody-based oncology products addressing clear unmet pediatric and adult medical needs. With the right partnerships and collaborations, we envision changing the course of cancer treatment and improving outcomes for patients and their families.
We have offices in New York City (US), Princeton, New Jersey (US) and Hørsholm, Denmark (near Copenhagen). We also have a laboratory based in Nutley, New Jersey (US).
Y-mAbs has an exciting future ahead. If you are passionate about being part of a truly patient-centric organization focused on developing and commercializing cutting-edge therapies to treat a variety of cancers, we want to hear from you!
About the Role
As the Senior Manager, GMP Global QA at Y-mAbs, you will contribute to the maintenance and continuous improvement of the company’s Quality Management System, ensure adherence to the regulatory requirement and the industry standards, and support the manufacturing of effective and safe products.
Job Responsibilities
- Maintenance of SOP system
- Oversight of employee training activities
- Change management
- Vendor management
- Maintenance of Product Specification Files
- Assessment of quality events (deviations, root cause investigations, CAPA, OOS)
- Preparation of Quality Management Reviews
- Quality Risk Management activities
- Hosting of regulatory GMP inspections and audits by external parties
- Self-inspections
Key Qualifications
- 5+ years of experience in pharma/biotech industry in Quality Assurance, GMP
- Thorough knowledge of cGMP requirements
- Robust quality culture
- Comprehensive experience in quality systems (handling of quality events, change management, training, vendor management)
- Knowledge of manufacturing processes for biologics and sterile products is an advantage
- Proficiency in English
- Strong skills in writing and handling of documentation
- Good computer skills, experience with EDMS (knowledge of Veeva is an advantage)
- Good planning, prioritization and task completion abilities
- Good communication skills, both internally and with external parties
- EU citizenship, residence in Denmark
The Senior Manager will be a part of a lean QA team and report to the VP Global Quality Assurance.
This position is based in our Hørsholm (Copenhagen), Denmark office. There is no significant travel activity associated with this job.
Interested in Applying
If you are interested in joining Y-mAbs and becoming part of our team in a fast-moving environment that offers a unique combination of scientific insight, entrepreneurship, and exciting challenges, please apply!
Equal Employment Opportunity Statement
It is the policy of Y-mAbs to provide employment, training, compensation, promotion and other conditions of employment without regard to a person’s sex/gender, pregnancy (including childbirth, breastfeeding and related medical conditions), age, race, color, religion, creed, sexual orientation, gender identity, gender expression, genetic information, marital status, familial status, civil union or domestic partner status, nationality or national origin, ancestry, citizenship, immigrant status, military status, veteran status, handicap, physical or mental disability, use of a trained service animal, medical condition, atypical hereditary cellular or blood trait, victim of domestic violence crime, sexual assault or stalking or membership in any “protected group” under federal, state or local law. This policy applies to all conditions of employment including but not limited to recruitment, selection, placement, transfer, promotion, training, compensation, benefits and termination.
