Lead Biopharmaceutical Quality Assurance Manager for International Projects
17 hours ago
We are seeking a highly experienced Biopharmaceutical Quality Assurance Manager to join our team in Ballerup, Denmark. As a key member of our international quality organization, you will be responsible for ensuring the highest standards of quality in our Investigational Medicinal Product development.
This is an excellent opportunity to work with a unique QA possibility within biotechnology development activities, including early and late-stage projects for antibodies, bi-specifics, and Antibody Drug Conjugates (ADC's). You will have influence on our shared quality system and be part of a dynamic, international environment.
The ideal candidate has a strong background in GMP compliance, experience in project development work, and knowledge of FDA, EMA, and ICH guidelines. A relevant academic degree in life science and at least 5-10 years of experience working with QA and development are required.
Key Responsibilities- Maintain and further develop our Quality System, including shared CMC procedures and local Symphogen Quality Management System.
- Participate in project development work, providing GMP compliance expertise.
- Evaluate and approve processes, including audits of Contract Development Manufacturing Organizations (CDMO's).
- Supervise GMP manufacturing of clinical trial material at CDMO's.
- A relevant academic degree in life science (MSc pharm or similar) and at least 5-10 years of experience working with QA and development.
- Up-to-date GMP knowledge, including current FDA, EMA, and ICH guidelines within the pharmaceutical area.
- Experience from the biopharmaceutical industry with IMP manufacturing for clinical trials.
- QA management experience within project work in a multi-cultural environment.
We offer a competitive salary based on qualifications, flexible working hours, and a comprehensive benefits package, including opportunities for professional growth and development.
The estimated annual salary range for this position is between €80,000 - €120,000, depending on your qualifications and experience.
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