Associate Director, 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 an Associate Director, 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 Associate Director, GMP Global QA at Y-mAbs, you will provide QA support to CMC Development and Product Supply teams, function as a Delegate Qualified Person, contribute to the continuous improvement of the company’s Quality Management System, and maintain efficient collaboration with quality units of contract manufacturing organizations. The products in scope are both commercial products and Investigational Medicinal Products.
Job Responsibilities
Product related QA:
- QA expert assigned to the biological Drug Substance team
- Qualified Person delegate with responsibility for release of biological Drug Substance
- Change management and oversight of regulatory compliance
- Maintenance of Product Specification Files
- Review of batch production and testing records
- Preparation of Annual Product Review
- Assessment of quality events (deviations, root cause investigations, CAPA, OOS)
QA Systems:
- Maintenance of SOP system
- Supply Chain monitoring
- Preparation of Quality Management Reviews
- Quality Risk Management activities
- Hosting of regulatory GMP inspections and audits by external parties
- Self-inspections
Key Qualifications
- Thorough knowledge of cGMP requirements
- Education required by the EU Directive for a Qualified Person
- 7+ years of experience in pharma/biotech industry in Quality Assurance, GMP
- Knowledge of biological Drug Substance manufacturing and experience with contract manufacturing activities
- QP or Delegate QP experience is beneficial
- Comprehensive experience in quality systems (handling of quality events, change management)
- Experience as GMP auditor is an advantage
- Proficiency in English
- Good computer skills, experience with EDMS (knowledge of Veeva is an advantage)
- Ability to work independently, with multiple tasks, and under ambitious timelines
- Good planning and task completion abilities
- Good collaboration skills, both internally and with external parties
- EU citizenship
This is a hybrid role, and the successful candidate must be able to commute to our office in Hørsholm (Copenhagen) Denmark.
Travelling: up to 12 days per year
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.
