Magnet.me  -  The smart network where hbo and wo students find their internship and first job.

The smart network where hbo and wo students find their internship and first job.

This opportunity has expired. It is therefore no longer possible to like or apply.

See similar opportunities instead

Senior Quality Assurance Specialist

Posted 23 Mar 2024
Work experience
5 to 7 years
Full-time / part-time
Full-time
Degree level
Required language
English (Fluent)

Your career starts on Magnet.me

Create a profile and receive smart job recommendations based on your liked jobs.

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.

Responsibilities

  • 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

Requirements:

  • 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.

For the past three decades, members of our team have been at the forefront of cancer immunotherapy. Today, we 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.

Pharmaceutical
Hoofddorp
2,000 employees