Quality Manager QP
Based in Amsterdam, Netherlands
The role is with Kiadis, a Sanofi company
About the Opportunity
As QA Manager/ QP you will act as a leader representing the quality department. This role is ideal for an experienced candidate looking to further progress their career. The person will also be able to define elements of the role. Sanofi backing is substantial and there are lots of new
projects coming up at Kiadis.
You are responsible for the coordination of quality operations of both in-house and outsourced manufacturing ensuring production and quality control activities are performed in compliance with
Sanofi’s quality standards and GMP/GDP requirements. The scope of the role includes oversight of in-house manufacturing, CMO manufacturing and QC release testing laboratories operations.
We are Kiadis, when it comes to life-threatening diseases, we are one family. Kiadis Pharma, a Sanofi Company is leveraging the natural strengths of human immune systems to source the best cells to produce innovative therapies for life-threatening disease. We are focused on NK cell research & development to maximize the potential of NK cell therapeutics. Kiadis is a leader in creating cutting-edge science in the exciting and emerging fields of cell therapy and immuno-oncology.
About growing with us
As a Quality Manager In your day-to-day you will
- Support the Head of Quality in maintaining and improving the quality system.
- Act as Qualified Person for Amsterdam R&D Site and perform all related QP activities.
- Provide quality guidance and ensure the production and control activities performed at Amsterdam R&D Site manufacturing and testing locations are in compliance with GMP requirements and quality agreements.
- Represent QA in projects both at the Amsterdam R&D Site and within the wider Sanofi network.
- Participate in regulatory inspections at the Amsterdam R&D Site as required.
- Perform audits of the Amsterdam R&D Site suppliers and service providers as required.
- Lead efforts in continuous improvement initiatives of GMP compliance.
- Provide guidance and support to Amsterdam R&D Site concerning compliance with relevant quality and regulatory policies.
- Support the development of strategies to improve quality working practices and systems.
- Build cross functional relationships to support Quality Operations throughout the Amsterdam R&D Site organization and at CMO or testing laboratories.
- Support internal and external quality audits and inspections.
Our Quality Assurance department works with a strong motivation to deliver safe and effective personalized medicine to our patients. Our team of highly skilled international professionals ensure compliance on many levels, they also train our employees, which has resulted in quality being a key component of our company culture. As a leader of the Quality Assurance team, you will work with a high sense of urgency, work to continuously improve our processes, and collaborate with different people from all over the world. Join us and see for yourself how you can make an impact.
We are looking for someone that shares our love for cell therapy, and likes being part of a dynamic organization. You will be proactive by nature with a QP Mindset. It would be great if you have the following requirements
- University degree in biomedical and/or life sciences.
- Minimum of 5 Years QA Pharmaceutical / Biotechnology experience.
- Leadership skills and experience.
- Experience as QP in biotechnology is an advantage.
- In depth experience with Quality Systems and Quality Management programs.
- In depth knowledge of EU & FDA regulatory agencies expectations.
- Experience overseeing contract manufacturing and testing vendors.
- Fluency in English, other languages are a plus.
Inspire your Journey.
What Kiadis can offer you
- A close knit, family feel work environment, in which you can develop your talent and realize ideas and innovations within a competent team.
- An attractive, market-oriented salary aligned with your qualifications and including social benefits
- An individual and well-structured introduction and training when you onboard.
- You can create your own career path within Kiadis. Your professional and personal development will be supported purposefully.
- As a Sanofi company you will have the opportunity to constantly grow, as Sanofi provides international career paths as well.
Pursue Progress. Discover Extraordinary.
Link to Career page https://www.kiadis.com/careers/
Own your future. Make your move!
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.