Vacancy Director of QC Operations – Leiden


Organization

18 NOV ’21: For a global Biopharmaceutical company focused on discovering, developing and delivering innovative medicines for patients with serious diseases, I am currently recruiting a Director of QC Operations. Their medicines are helping millions of patients around the world in disease areas such as oncology, cardiovascular and immunoscience. They have built a sustainable pipeline of potential therapies, and are leveraging translational medicine and data analytics to understand how they can deliver the right medicine to the right patient at the right time to achieve the best outcome. Currently, the organisation is experiencing an interesting phase with ambitious plans for the future. They are at the moment actively recruiting for high level candidates, such as this Director of QC Operations.

Function

As the Director of QC in their new build cell therapy facility, you will be responsible to provide senior leadership to the organisation’s QC operations and oversee the cGMP release testing and sample management activities. This to ensure an efficient and high quality release of the product to cell therapy patients. You as the Head of all QC operations will be seen as a key member of the team and organisation and responsible for the design, implementation and continuous improvement of all systems and processes in support of the cell therapy QC laboratories. In addition, since you are on a key role, you will be part of the organisations Quality Leadership team and function as an expert for quality principles and compliance with in the facility. In the coming years you will not only be end-responsible for all QC related operations, but also for setting up the complete QC organisation. This means that you will have a lot of freedom to do so, for instance hiring the right professionals. The aim is for now to hire between 80 and 100 people you will be responsible for. Therefore, you do need the capacity to demonstrate leadership as well building an organisation from scratch. In this part you will work on defining departmental roles and accountabilities, and hire, integrate and develop high quality talent capable of delivering against the department’s goals and objectives.

In addition, you will also be (end) responsible for the following:

  • Establish and communicate performance objectives for QC Operations staff that are consistent with the business unit and Quality goals
  • Define and enforce performance measures, provide developmental feedback and coaching, and create a collaborative environment that attracts, develops, and retains the best talent
  • Direct the training and scheduling of QC Operations staff to assure testing activities occur in an efficient and cGMP compliant manner
  • Accountable for the efficient and timely technology transfer of test methods
  • Direct programs or procedures which assure the proper qualification, calibration, operation and maintenance of laboratory equipment, the timely data analysis and reporting of trends, and the completion of written investigations in response to unusual or unexpected results or deviations
  • Direct QC department programs and projects related towards the goal of continuous improvement
  • Participate in the site team, which prepares for, hosts, and responds to regulatory inspections, reviews, and approvals of the facility and products
  • Accountable for on time, quality laboratory investigations and associated CAPA within the electronic investigation management system (e.g. Infinity), as needed
  • Support completion of Annual Product Quality Review and periodic investigation trending reports
  • Verify compliance with applicable organisations policies and procedures and ensure consistency with other site procedures and/or specifications
  • Responsible for managing the QC Operations budget

Requirements

The organisation expects that, as the Director QC, that you will bring senior leadership experience where you have worked with groups of approximately 20-50 big. Due to the importance of the role we expect that you have in depth knowledge of common QC procedures, techniques, and laboratory equipment, and the application and interpretation of most relevant GMP concepts and compendia requirements

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

  • Experienced with building, leading and managing a large, multi-levelled organisation
  • At least 10 years of progressive managerial experience within the quality function of the pharmaceutical health care industry
  • Proficient knowledge in assay methodologies such as molecular biology and flow cytometry assays
  • Extensive knowledge of EU cGMP regulations and guidance (US cGMP knowledge is preferred)
  • Experienced in EMA inspection preparation and management
  • Knowledge of applicable business systems
  • Known with cell therapy or biologics manufacturing and ATMP will be considered as highly desirable

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:

  • Base annual salary between €160,000 and €170,000 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.

Aron Berhane
Senior Associate | Biotech & Pharma

+31 6 30 30 69 82
+31 23 754 86 60
a.berhane@qtcrecruitment.com