Vacancy Director Compliance and Quality Systems – Leiden


Organization

15 SEP ’22: For a global biopharmaceutical company focused on discovering, developing, and delivering innovative medicines for patients with serious diseases, we are looking for a Director, Quality System.& Compliance, Cell Therapy. Currently, the organisation is building a new state-of-the-art facility focused on commercial cell therapy manufacturing. To make this happen they are recruiting senior staff for their Quality department.

Function

The Director will be responsible for providing senior leadership to the Compliance activities related to internal and external regulatory requirements, as well as making sure that the Quality System is up to standard. You are ultimately responsible for the complete set- and start-up of the department. This means that you will hire, train, and develop qualified Compliance and Quality Systems. In here you can think of ensuring that your staff has adequate training, education, and experience to perform their GMP-related job function effectively.

In addition to this, you will also be responsible for:

  • Leads and facilitates Health Authority inspections and approvals of the facility and products;
  • Manages responses and leads efforts;
  • Leads the site self-inspection program.

Requirements

The organisation expects that, as the Director of Compliance & Quality System, you will bring senior leadership experience where you have worked with groups of 15-35 people. Due to the importance of the role, we expect that you have obtained your experience in a Quality role within a commercial biologics/cell therapy manufacturing organisation.

Next to this, we also expect you will bring the following experience:

  • Expertise in preparing for and leading within Health Authority inspections, preferably with experience leading facility Pre-License Inspections;
  • Expertise in ICHQ9 and Quality Risk Management Program Implementation is required;
  • Strong experience in quality assurance operation and compliance with commercial biologics or cell therapy;
  • Extensive knowledge of EMA GMP regulations and guidance.


Offer

You will come across a company that is passionate about making an impact on the lives of patients with serious diseases. Empowered to apply their individual talents and diverse perspectives in an inclusive culture, their shared values of passion, innovation, urgency, accountability, inclusion, and integrity bring out the highest potential of each of their colleagues.

The organisation is also able to offer you:

  • Competitive base salary;
  • Bonus potential of 23%;
  • Long term Incentive plan;
  • Car or car allowance;
  • 30 holidays;
  • Insurances and pension plan.

Application

If you are interested in this job, or in similar ones, please feel free to contact me directly.

Aron Berhane
Senior Recruitment Associate | Biotech & Pharma

+31 6 30 30 69 82
+31 6 82 56 44 01
a.berhane@qtcrecruitment.com