(Senior) Manager Quality Assurance
Aduro Biotech, Inc. is at the forefront of discovery, development and commercialization of breakthrough immunotherapies, alone or in combination, that make transformative advances in the treatment of challenging diseases. We provide a workplace where employees excel, thrive and deliver value to patients, their families and our partners. Aduro Biotech Europe is located in Oss, The Netherlands. To strengthen our team, we are looking for a (Senior) Manager Quality Assurance
Location: Oss, The Netherlands
Reports into: Director Quality Assurance, Aduro Biotech Europe
Summary & Scope of Position:
The QA manager will ensure that handling, manufacturing and distribution of products at our contract organizations are in compliance to cGMP and companies quality standards. From your broad experience within Quality Assurance and biopharmaceuticals you are able to apply quality standards throughout different stages of product development. you will be responsible for correct use of quality systems such as writing and review of procedures, protocols and report, review and release of batch records, perform audits and give GxP training within Aduro. Besides this you will perform initiation, review and assessment of deviations, change control requests, CAPA’s, OOS and other Quality System input.
- Reviewing Batch records, (QC) test record and associated documentation to complete batch disposition
- Support performing internal and external audits.
- Management of Contract Organizations from a quality perspective.
- Archiving, writing, reviewing and approving applicable controlled documentation, such as procedures, (audit) reports, protocols and other quality related documentation.
- Supporting or performing initiation, review and assessment of deviations, change control requests, CAPA’s, OOS and other QMS input.
- Support the processing of documents in the Electronic Document Management System (EDMS) to route new documents and document revisions for review and approval.
- Support the electronic Learning Management System (LMS) and in-house training program.
- Support CMC project activities such as risk assessment, comparability, method validation from a QA point of view.
- Performing QA related tasks within a dynamic, flexible and successful biotech company.
- Bsc degree in a scientific discipline or equivalent with at least 3-years QA experience in pharmaceutical and/or biotechnology companies
- Broad-based industry regulations/standards knowledge and current understanding of quality trends and intents for Biological products
- In-depth knowledge of multiple biologic manufacturing processes is desirable
- Experience with batch record review and release
- Strong communication (verbal, written, listening); interpersonal skills and ability to communicate across multiple disciplines effectively
- Ability to grow and integrate the needs of the organization
- Attention to detail and accuracy. Flexible; ability to adapt to changing priorities
- Travel is required (up to 20%)
Aduro Biotech Europe offers a competitive salary and benefits package. If you are a qualified candidate, please send us your resume and cover letter including a statement of interest, availability, and experience in Word or PDF format to: careersABE@aduro.com. For more information you can call Aduro Biotech Europe at phone number: +31 (0) 88 012 1400.
Aduro Biotech, Inc. is an Equal Opportunity Employer.
Acquisition to this vacancy is not appreciated