Manager, GMP QA (GQP/GMP)
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Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
extranotordinary
The Role & Department
- As MAH QA implement and promote GQP operations (release control manufacturing site control quality information control change control quality agreement training self-inspection recall management of documents and records etc.) continuous improvement of quality management system and product quality.
- Collaboration instruction and guidance on quality with subcontractors (Explanation of Japanese requirements audit change control deviation control etc.)
- Collaboration with Global QA and Supply Chain (Deployment of Genmab Global policy to Japan communication of necessary matters in Japan to Global establishment of better SOPs in collaboration with Global)
- Establishment of Marketing QA Department that handles antibody drugs and practical lead
- Actions for new product introduction (cooperation with new CMOs GMP compliance inspections responding to PMDA inquiries when applicable preparing product quality standard document etc.) and renewal of MAH business license and management of other Genmab licenses
Knowledge and skills required
- Broad knowledge and experience of GQP/GMP (operations in contact with MAH QA on the manufacturing site side are also acceptable)
- GQP/GMP QA experience of pharmaceutical companies (5 years or more)
- Business English
- Communicating effectively with others (i.e. co-workers authorities etc.) to achieve win-win situation.
- Demonstrated ability to build and foster teamwork and strong ability to work across functions; strong relationship building skills.
About You - additional qualities you bring to the table
- You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment
- You bring rigor and excellence to all that you do. You are a fierce believer in our rooted in science approach to problem-solving
- You are a generous collaborator who can work in teams with diverse backgrounds
- You are determined to do and be your best and take pride in enabling the best work of others on the team
- You are not afraid to grapple with the unknown and be innovative
- You have experience working in a fast-growing dynamic company (or a strong desire to)
- You work hard and are not afraid to have a little fun while you do so
25Tbispecific T-cell engagersADC
2030
1999
Required Experience:
Director
Key Skills
- Quality Assurance
- FDA Regulations
- Food Industry
- Food Safety Experience
- ISO 9001
- Quality Systems
- Food Processing
- Quality Control
- Quality Management
- QA/QC
- Selenium
- HACCP
About Company
Founded in 1999, we are an international biotech company committed to improving the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, our passionate, innovative and collaborative team has invented next-generation antibody technology platforms ... View more
