Sr Quality Assurance SpecialistNetherlands - HoofddorpQualityRegular
Kite, a Gilead Company
At Kite, we are at the forefront of immunotherapy and engineered T cell therapy. We are helping change the paradigm of cancer treatment and we are revolutionizing individually tailored treatments. That means a fast moving and constantly changing environment, where we make discoveries every day – discoveries that include our own capabilities and our individual potential.
We’re currently seeking to recruit highly motivated talents for different positions, to join us and be part of our exciting journey in the development of innovative cancer immunotherapies and their translation to the treatment of patients with cancer.
We are looking for a Senior Quality Assurance Specialist in the ACE & International Compliance team. This position will be responsible to support regional compliance activities.
- Manage quality agreements with Gilead affiliates
- Ensure Quality records are initiated, investigated/evaluated and resolved/implemented or approved as assigned to team
- Prepare and provide training to affiliates
- Interact with the affiliates on compliance issues and provide advice, explanation or other support
- Build productive and constructive relationships with other functional teams within Kite and Gilead.
- Support inspection readiness plans and interact with regulatory agencies during inspections as needed.
- Responsible for providing guidance on interpretation and application of specified regulations.
- May assist in implementation of standard operating procedures and systems needed to comply with regulatory requirements.
- Participates in and/ or leads projects within the function and/ or cross-functional
- Identify and execute OE activities
- Perform other duties as assigned
- 5+ years relevant working experience in a GMP Quality environment and a MS
- Proactive, can do mentality
- Knowledgeable with cGMP’s
- Strong stakeholder management skills
- Demonstrates excellent verbal, written, and interpersonal communication skills.
- Demonstrates excellent attention to detail, and ability to consistently meet high standards required in compliance
- Ability to work in a dynamic environment
- Excellent organization skills and ability to work on specified projects with tight timelines is required.
As we extend our global reach, we need colleagues interested in change, challenge and in building a new future together.
If you have the ability to thrive in a dynamic and fast-paced environment and feel that the moment has come for you to be part of such an exciting journey towards eliminating the burden of chronic cancer care, don’t miss out on this opportunity to join us and discover your sense of purpose.
Would you like to know more before you apply? Please visit us at www.kiteamsterdamcareers.com
or contact our Talent Acquisition Team at CareersEU@kitepharma.com.
Only candidates in possession of a valid EU work permit will be considered.
Recruitment agencies: We seldom make use of agencies, and when we do, we have a PSL in place. We would appreciate if you did not contact hiring managers or the recruitment team directly, since we will not be able to respond to you.