HUB Organoids is looking for an experienced senior QA Officer who wants to use his/her expertise to support our mission to the acceleration of drug discovery pipeline for our customers, applying our state-of-the art organoid ("a patient in the lab") technology. You contribute to the success of HUB by ensuring the quality and compliance of our Quality Management Process and by safeguarding the high quality standards for HUB Organoids products.

HUB Organoids BV is part of the Life Science business of Merck KGaA, Darmstad, a leading science and technology operating across healthcare, life science and electronics. Making a positive difference to millions of people’s lives every day by creating more joyful and sustainable ways to live.

Scope of the Position

Join our QA team in a fast-growing, dynamic and world leading biotech company. As senior QA Officer you support the business in its core activities by developing, implementing, improving and maintaining the quality management system (QMS) with the aim to be compliant with ISO9001. Thereby ensuring that after its implementation it is state of the art and in compliance with GxP legislation, guidelines and/or Bio-technology quality expectations. You assist and advise colleagues (inside and outside the own department) with regard to compliance to the QMS and fulfil a substantial role in QA-related projects. You will be working closely with the QA manager and may represent the company at relevant audits or meetings.

You are flexible and adaptable on the one hand but on the other confident in assuring compliance to the QMS. Next to this, you have worked within QA and gained experience in establishing and improving a QMS, including compliance to applicable laws and regulations. With 3-5 years of QA experience, you know how to communicate QA topics in an effective, friendly, and respectful way to different organizational levels.

You thrive in an environment in which part of the quality related processes still needs to be defined and love working together with different stakeholders such as the research team, business developers and project managers.

What will you do?

• Establishment and further improvement of the quality management system (QMS) according to ISO9001.
• Write, implement and review SOPs and other QA related documentation in accordance with applicable guidelines relevant to a QMS.
• Create awareness for compliance to the procedures and processes within the QMS and quality expectations throughout the company for instance by training.
• Represent QA in projects, identify compliance risks and ensure they are addressed appropriately within the project.
• Acting as a facilitator for associated risk assessments and root cause analysis according to required standards
• Handling complaints, deviations, CAPAs and change controls
• Conduct and be part of internal and external audits to determine compliance with applicable guidelines.
• Support QA officer in document control and maintenance of the QMS
• You have a masters degree in the field of Life sciences or another related area.
• You have 3 to 5 years of relevant QA experience in a laboratory environment or biotech company, preferably in a commercial, ISO-certified (or alike) environment
• You are an all-round experienced QA officer, e.g. able to write SOP and guide all kinds of quality records
• You are flexible and adaptable and able to handle changing priorities and tasks.
• You are proficient in English (written and verbal).

What will you bring?

• You have a masters degree in the field of Life sciences or another related area.
• You have 3 to 5 years of relevant QA experience in a laboratory environment or biotech company, preferably in a commercial, ISO-certified (or alike) environment
• You are an all-round experienced QA officer, e.g. able to write SOP and guide all kinds of quality records
• You are flexible and adaptable and able to handle changing priorities and tasks.
• You are proficient in English (written and verbal).

What we offer and who we are

• Friendly and international environment make you feel home.
• Competitive salary with attractive benefits like 30,5 leave days plus national holidays.
• Pension Plan with 2/3 contribution paid by HUB.
• Flexible work from home policy.
• HUB, located in Utrecht (The Netherlands), is an open and energetic organization, where a multi-cultural team is passionate to refine organoid development and foster organoid adoption globally. Our technology brings a ‘patient in the lab’ by utilizing patient-derived organoids to develop and test drug and other treatment. Experience a stimulating work environment, opportunities for professional growth, and the chance to make a lasting impact on patient-centric research. We’re a fast-growing, world leading biotech company in organoid technology and if you are passionate about pushing the boundaries of scientific innovation, apply today!