Vacancy Director QA Engineering – Utrecht


Organization

23 NOV ’21: For a global organisation in the pharmaceutical market that focuses on, among other things, cell therapy, we are looking for a Director QA Engineering. This organisation’s mission is to discover, develop and deliver innovative medicines that help patients overcome serious diseases.

Function

This Director QA position is perhaps the most important function for the transition that this organisation will make. The production site of this organisation is moving to the Netherlands and you are responsible for the tech transfer, setting up the QA department with the aim of establishing an extremely strong QA team here.

Activities

  • You are responsible for ultimately managing a QA department made up of officers, specialists and managers, which will consist of approximately 40 people
  • You are responsible for all daily activities of the QA department
  • You are responsible for compliance with the master plan for site validation, start-up operations, product transfers and new product introductions
  • You will ensure QA oversight of all technical transfers, process validations and process performance qualifications to ensure successful execution and documentation
  • You provide QA oversight of qualification and validation of life cycle activities related to facilities, instruments, equipment, processes and methods
  • Oversee validation plans, qualification protocols and associated reports and procedures, if applicable, as well as calibration/maintenance programs
  • Provide QA leadership to the conception, design, execution and commissioning and qualification/validation of major capital projects supporting GMP operations
  • Provides appropriate support through the QA Engineering team to technical investigations requiring complex root cause analysis, CAPA’s and resolution efforts
  • Provides and ensures substantive expertise support in the quality team when writing and/or reviewing legal license registrations to answer questions from health authorities
  • You ensure compliance with industry/regulatory procedures and expectations including facility/equipment checks warranty and release before, during and after production activities
  • You are responsible for the cooperation with stakeholders inside and outside the production facility. You communicate about the status of equipment, facilities and systems; monitor progress and issue status reports
  • You will contribute to the development and implementation of PAI and commercialisation readiness plans as well as serve as an expert in the maintenance of the License to Operate site

Requirements

In addition to excellent people management skills, you are the ideal candidate if you bring the following with you:

  • At least a completed bachelor’s degree in a Life Sciences direction
  • Minimum of 10 years working in a quality, engineering, manufacturing role (or any combination) within a Biopharmaceutical, Cellular Therapy or Gene Therapy Organisation. Of which at least 5 years in a managerial position
  • Strong leader that has developed high performing, independent and capable teams of experienced professional employees
  • Experience with coaching others, talent selection, developing others, decision making, building relationships, innovation management, and resource allocation required
  • Knowledge of cGMP regulations, automation standards from relevant health authorities including all guidelines applicable to biologics
  • Familiar with automation requirements/guidance and validation lifecycle for relevant manufacturing and QC equipment and instrumentation, as well as GMP software and electronic systems
  • Capable of recognising and resolving Quality issues, particularly of a technical nature; informs management of proposed solutions. Seeks management guidance on complex issues; develops procedures
  • Proven capability for leading project teams and drives team performance and results
  • Contributes to departmental performance and quality initiatives; able to conceptualise impact of Quality initiatives in terms of cross-functional teams
  • Possesses capability for effectively managing internal and cross-functional conflicts and disagreements, but able to stand alone on issues

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.

  • Base annual salary between €160,000 and €180,000 based on fulltime including 8% holiday allowance
  • Bonus potential of 23%
  • Car or car allowance
  • 30 holidays

Application

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

Romy Snijder
Consultant | Biotech/Pharma division

+31 6 58 81 46 32
+31 23 754 86 60
r.snijder@qtcrecruitment.com