Associate Director, QC Material Operations

The organisation

For a global Biopharmaceutical company focused on discovering, developing and delivering innovative medicines for patients with serious diseases, we are looking for an Associate Director, QC Material Operations. Their medicines are helping millions of patients around the world in disease areas such as oncology, cardiovascular and immunoscience. 

The position

This is how you will make the difference
The company has built a sustainable pipeline of potential therapies, and are leveraging translational medicine and data analytics. This to understand how they can deliver the right medicine to the right patient at the right time to achieve the best outcome. One of their biggest and exciting projects is the build of their new cell therapy manufacturing facility that will focus on helping patients in Europe. In order to realise this they are hiring the right people in the several departments, such as the Associate Director, QC Material Operations.

Tasks & responsibilities

As the Associate Director, QC Material Operations you will be responsible to provide senior leadership to the organisation’s QC operations related to the raw materials, consumables and critical reagens. You’ll also provide lab management as well as timely communication regarding prioritisation for testing of these consumables, raw materials, and critical reagents across multiple sites. In addition, you’ll drive and support critical reagent, consumables and raw materials testing strategy, and manage method validation and transfer. In order to make this tangible you oversee the review and approval of documents to ensure appropriate documentation of ?data and changes, and ensure compliant and consistent review and approval of testing data ensuring consistent use of data integrity principles. Regarding the documentation part; performing cross-functional review and approval of document changes for SOPs, methods, protocols, specifications, and other technical documents, is part of your responsibilities. ?

In the coming 1,5 years the greater part of your work will consist out of the complete set-up of the QC operations organisation. Together with your peers and Director QC, you will make this happen by 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,

In addition, you will also be working on:

• Thinking about the strategy with regards to the raw materials, consumables and reagents
• Management of programs related to these raw materials and consumables used in CAR T manufacturing late stage clinical and commercial phase
• Provide oversight oversight of daily QC activities

Candidate profile

What you bring
The organisation expects that, as the Associate Director, QC Operations, that you will bring seniority where you have worked within a biopharmaceutical environment, with leadership experience where you have worked with groups of approximately 10-30 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. You are also an individual who gets energy from building something from scratch, and has the ability to take people with you. Furthermore, you are proactive, able to deal with changes, focused and willingness to go the extra mile to a certain degree.

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

• At least 10 years of progressive and relevant experience and at least 5 years of leadership experience with direct reports, within the quality function of the pharmaceutical health care industry 
• Bachelor degree, preferably in Chemistry, Microbiology, or related
• Advanced understanding of pharmaceutical regulatory requirements and their impact ?to commercial laboratory operations.
• 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

The offer

What's in it for you
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 €110,000 and €130,000 based on fulltime including 8% holiday allowance 
• Bonus potential of 14%
• Car or car allowance
• 30 holidays with the possibility to buy/sell up to 10 days
• Health-, and life and accident insurance
• Pension plan

Interested?

You can apply to this position by using the link below. For more information please contact Aron Berhane, +31 6 30 30 69 82.