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Associate Director, Quality Engineering

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19 DEC ’23: For a global biopharmaceutical organisation focused on discovery, development, and delivery of innovative medicines for patients to overcome serious diseases, we are currently looking for an Associate Director, Quality Engineering. This role is particularly interesting, as you will be the essential link in the Quality team acting as the SME on technical elements in the new Cell Therapy manufacturing facility.

Details

Biotechnical

Quality/RA

Oegstgeest - Netherlands

40 uur per week

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Zo maak jij het verschil

The Associate Director, QA Engineering is responsible for leadership, establishing processes, and providing guidance to the QE team. In this role, senior-level expertise is provided to other functions related to activities the QE team is representing quality for. Moreover you will focus on the following: Sets and executes strategy & daily activities of the QE team; Champions proactive identification and resolution of technical and compliance issues/gaps; Ensures compliance with the site validation master plan, assists with start-up operations, and supports product transfers/new product introductions; Provides QA oversight for Technical Transfers, Aseptic Process Validations, Process Performance Qualifications, and Comparability Studies, as well as process and analytical changes; Leads Qualification and Validation lifecycle activities; Reviews and approves documentation in support of GMP operations; Provides appropriate support through the QA Engineering team for technical investigations requiring complex root cause analysis and resolution efforts (i.e., CAPAs).

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Wat jij mee brengt

With a Bachelor's degree and at minimum 12 years relevant work experience, including 5 years of leadership, you bring along:
  • Strong leadership with experience in coaching, talent selection, and developing others;
  • Previous experience in Quality, Engineering, Manufacturing roles within commercial biopharmaceutical, cellular therapy, or gene therapy organisations;
  • Knowledge of cGMP regulations, automation standards, and ATMP Regulations;
  • Familiar with Cell Therapy QC methods and method transfer;
  • Skills in planning, organising, and project management;
  • Ability to recognise and resolve quality issues, particularly technical in nature. Effectively manages internal and cross-functional conflicts and disagreements.

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Jouw voordelen

Besides the ability to build on one of the most advanced Cell Therapy facilities in the Netherlands, allowing a significantly reduced barrier for patients to undergo immune-system treatments in entire Europe, the organisation offers the following as a package:
  • Competitive base salary;
  • Bonus opportunity;
  • Premium Pension plan;
  • Health insurance;
  • Sport benefit plan;
  • 30 holidays (with option to buy/sell 10 holidays).

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