Job Description
Senior Manager / 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 a Senior Manager or 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
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 or Associate Director, 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
- QA support for CMC Operations
- SME for quality issues related to manufacturing Biologics
- Review of batch production and testing records
- Guidance to product Specifications and shelf-life assignment
- Preparation of Annual Product Review
- QA related activities in Change Control
- Quality Risk Management activities
- Maintenance of Product Specification Files
- Assessment of quality events (deviations, root cause investigations, CAPA, OOS)
- Preparation/review of SOPs for QA GMP area
- Preparation of Quality Management Reviews
- Participation in regulatory GMP inspections and audits by license partners
Key Qualifications - 5+ years of experience in pharma/biotech industry in Quality Assurance, GMP
- Thorough knowledge of cGMP requirements
- Knowledge of CMC for Biologics and experience with Biologics manufacturing activities
- Comprehensive experience in quality systems (handling of quality events, change management)
- Knowledge of aseptic manufacturing is an advantage
- English – professional working proficiency
- Strong document writing skills and handling of documentation
- Strong computer skills, experience with EDMS (knowledge of Veeva is an advantage)
- Good planning, prioritization and task completion abilities
- Good collaboration skills, both internally and with external parties
You will be a part of a lean QA team and report directly to our VP, Global Quality Assurance.
This position is based in our Hørsholm (Copenhagen), Denmark office, with a requirement to be in the office 3-4 days a week. 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.
All decisions regarding conditions of employment must and will be based on the individual's overall qualifications and their ability to meet the requirements of the position.
