Amsterdam area | Biopharmaceuticals | MS Office | cGxP | Procedural Document Writing
Your new role
In this position you are responsible to prepare technical documents for global use within Operational Controls including: Qualification & Validation, Facilities Design & Maintenance, Vendor & Materials Management, Production & Disposition, and Product Distribution, and Governance Controls: Management Responsibilities, Training & Qualification, Event Management, Document & Change Management, Quality Risk Management. The tasks for this job include document authoring, coordination of review and comments resolution, approval, issuance, implementation, periodic review, and retirement. You will perform compliance assessment of procedural documents and support Global Product Development & Supply organisation for Kite's electronic document management system. Moreover, you will be working together with the SMEs/procedural document teams to identify and resolve issues and proactively use judgement to manage risk and uncertainty, and to anticipate the need for and implement contingency plans. Exercise sound judgement, using a risk-based approach, to ensure compliance with procedural document regulations, practices, and policies. You will collect and share best practices through direct communications and communities of practice.
What you'll need to succeed
You have in depth knowledge of cGxP requirements and global health authority regulations in
bio pharmaceuticals, and you bring with you more than 5 years of experience in the Biopharma/Pharmaceutical industry. Also, you have critical thinking analysing skills and exercising judgement on complex issues. You are a strategy thinker with project management concepts and strong influencing skills. Ability to participate in teams, foster partnerships across multidisciplinary teams and to resolve complex issues and differences in a creative, constructive and diplomatic manner.
Your new company
Kite, a Gilead company, is dedicated to achieving one of the most ambitious goals of 21st century medicine: curing cancer. This mission is at the heart of everything they do, from early research to product development. Kite has been at the forefront of cancer immunotherapy and today are a leader in engineered T cell therapy, changing the paradigm of cancer treatment with what is potentially the biggest breakthrough since the introduction of combination chemotherapy more than 60 years ago. With an unrelenting drive and a singular focus on cell therapy, our team is executing on our strategy to bring life-saving therapies to patients. With their brand-new production site in Hoofddorp and the R&D laboratories in Amsterdam, Kite is dreaming big. Now you can get the chance to be a part of this journey.
What you'll get in return
Hays Detachering | This is a project that will start with a contract for 1 year through Hays. Extension to stay within the department is anticipated. At this position, you will get a competitive salary and your travel expenses are covered.
What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call Ewa Tran at +31 6 43 45 29 76 now.
If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career. #1044455
Talk to a consultant
Talk to Anna-Maria Oikonomou, the specialist consultant managing this position, located in Amsterdam