Quality Assurance Manager - Operations

When it comes to life-threatening diseases, we are one family. 

We are Kiadis, a fast-growing biopharmaceutical company focused on the treatment of patients with blood cancers, aiming to make bone marrow transplantations safer, more efficient and more effective. We are committed to developing innovative cell-based immunotherapies for patients with life-threatening diseases, combining the innate and adaptive immune system.

We are looking to further strengthen our Quality Assurance team with a Quality Assurance Manager - Operations that is based in Amsterdam, The Netherlands or Ulm, Germany. 

The role

As a Quality Assurance Manager - Operations, you are responsible for the coordination of quality operations of both in-house and outsourced manufacturing. You ensure that the production and quality control activities are performed in compliance with GMP/GDP requirements.  

In this cross-functional role, you will collaboratively manage the daily activities of the Quality Assurance Operations team. You establish, develop and reinforce our processes/procedures around our CMO in Ulm, and encourage an improvement focused mindset around these amongst your team. 

In your day-to-day you will:

  • Oversight of Kiadis, CMO manufacturing, and Quality Control release testing laboratories operations. 
  • Build and maintain a high-performing team of Quality Specialists and/or Managers who have direct responsibility for Quality Assurance within Kiadis manufacturing and Quality Control testing locations.
  • Manage the Quality Assurance Operations resource scheduling to ensure sufficient support for on-going manufacturing and testing.
  • Participate in and manage regulatory inspections at Kiadis manufacturing and testing locations.
  • Perform audits of the Kiadis suppliers and service providers as required.
  • Provide guidance and support to Kiadis manufacturing and testing staff concerning compliance with relevant quality and regulatory policies and the development of strategies to improve quality working practices and systems.
  • Execute operational activities where needed including batch record reviews, deviation handling, change controls, etc. 

The department

As the Quality Assurance (QA) department, we endeavor to ensure product quality and patient safety through our daily work. We advocate and monitor company compliance to current guidelines, directives, regulations and applicable [inter]national laws. We do this by training our employees according to their roles and ensuring compliance with our Quality Management System (QMS), which results in quality being part of the company culture. All of this is safeguarded by executing internal audits. We also conduct external audits of all regulated outsourced and external supply activities (e.g. at CMOs and suppliers) to ensure compliance with Kiadis quality standards. All regulated operational activities are monitored by our department to provide assurance of quality and compliance, and to use our quality culture as a strategic advantage in delivering the right quality products to our patients. 

The ideal candidate

We are looking for someone with an HBO/University degree in biomedical and/or life sciences. Someone with great influencing and interpersonal communication skills. Who is willing to travel once a month, for a few days to our site in Ulm or the Netherlands based on the working location. 

We are looking for someone with:

  • A Minimum of 8 years of Pharmaceutical/biotechnology experience. 
  • Previous managerial experience in a supervisory role.
  • Great organizational skills, change agility and a hands-on mentality. 
  • In-depth experience with Quality Systems and Quality Management programs. 
  • In-depth knowledge of EU & FDA regulatory agencies expectations
  • Detailed and complete knowledge of international cGMP. 
  • In-depth knowledge of [inter]national regulatory inspections.
  • Maintained expert knowledge with current international pharmaceutical/biotechnology industry trends.
  • Is business fluent in English, and it would be a plus if you are fluent in German.

What we offer

Passionate people from all over the world, working together as one team, contributing to improving the lives of patients every day. We offer an exciting position in an innovative, dynamic and inspiring environment where you'll receive a competitive compensation package, autonomy and the opportunity to make your own mark within the organization.

We create an environment where ideas are shared, experiences are impactful, and talent is developed. Our inclusive and family-like environment will ensure you are in a place where you are appreciated and feel like part of the family.

Note to External Recruiters: All candidate activity and open positions are managed strictly through our Talent Acquisition Department. We kindly request that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Submission of unsolicited resumes prior to an agreement set in place between the Talent Acquisition Department and the recruiting agency will not create any implied obligation.

About Kiadis Pharma

Kiadis Pharma is a clinical stage biopharmaceutical company developing innovative products to make bone marrow transplantations safer and more effective for patients. Kiadis Pharma believes that its innovative products have the potential to address the current risks and limitations connected with allogeneic hematopoietic stem cell transplantation (HSCT), thereby meeting a significant unmet medical need with its products.

More about Kiadis Pharma

Contact information

Kiadis Pharma
Paasheuvelweg 25A
1105 BP Amsterdam
The Netherlands

+31 (0)20 240 52 50
+31 (0)20 240 52 51