Quality Assurance Manager, GCLP – Blueprint Genetics Oy, Espoo20.2.2021
Are you an experienced quality assurance professional who masters GCP/ GCLP? Do you want to be a part of building a quality management system in a global organization at the forefront of life sciences and healthcare? If so, then keep reading!
Blueprint Genetics is one of the fastest-growing clinical genetic testing companies for rare inherited diseases globally. We work with hundreds of clinics around the globe and the quality of our interpretation has been praised by many of the world’s best medical centers. As our company continues to grow, we are looking for a Quality Assurance Manager to join our Quality Assurance and Regulatory Affairs team in Keilaniemi, Espoo. This is a permanent, full-time position and can be performed remotely within the EU region as well.
In this role, you will be proactively building and maintaining a culture of quality at Blueprint Genetics. As Quality Assurance Manager, your main responsibility is to ensure that our quality assurance processes are in compliance with GCLP. You will work closely together with our Quality Management team in developing and maintaining our QMS. However, as a subject matter expert, you will have a key role in offering GCLP compliance support and training throughout the organization. Your main tasks will include:
- Developing and maintaining GCP/GCLP compliant QA processes in collaboration with QA/RA team
- Supporting other functions to develop GCLP compliant processes
- Performing routine quality assurance duties to ensure GCLP compliance
- Organizing GCP / GCLP training
- Hosting, coordinating, and supporting clinical trial sponsor, regulatory agency, and other audits
We are hoping to find a colleague who is an expert in their field and takes ownership of the tasks at hand, but who is also eager to learn and grow with us. You address quality issues diplomatically and use your strong interpersonal skills to coach and support others. You are a solution-oriented problem solver, equipped to work in a fast-paced and international work environment. Since we are a growing team that works across time zones, we value adaptability and flexibility in our team members. Last but not least, we aspire to find a person who fits the low-hierarchy and inclusive culture of Blueprint Genetics.
Our ideal candidate has:
- MSc from the field of life sciences, medicine, pharmacy, or equivalent
- Minimum 5 years of experience working in a GCP/GLP/GCLP environment and quality assurance
- Excellent interpersonal skills and ability to work autonomously and proactively in a fast-paced environment
- A solid understanding of GCP/GCLP, ICH and/or EMA requirements
- Experience in working with clinical trial sponsors and contract research organizations
- Good working proficiency in written and spoken English
- Strong communication skills and readiness to coach and support others
- Good understanding of other applicable regulations and industry standards including clinical laboratory is an asset
- Knowledge of auditing, equipment qualification, method and process validation, and software validation is an asset
What we offer
At Blueprint Genetics you will be a part of a global team of innovative, dynamic, and motivated people at the forefront of health and life sciences. We offer a chance to develop your skills further in a positive, low-hierarchy working environment. You will join a collaborative and agile team of 4 regulatory compliance and organizational excellence experts.
If this sounds like you, take the next step and apply latest on Sunday February 21. We will be interviewing candidates on a rolling basis.
If you have any further questions about the position, you can contact our Quality Manager, Olli Mikkonen by email: email@example.com or by phone +358 40 846 8833 on February 11 at 12-14 (EET) or February 12 at 16-17 (EET).