Are you a quality assurance professional with experience in working in a clinical lab? 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?
Blueprint Genetics is one of the fastest growing clinical genetic testing companies for 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 full-time Quality Assurance Manager to join our Quality Assurance and Regulatory Affairs team in Espoo, Finland.
We are looking for you, who wants to make a difference
In this role, you will have the unique opportunity to be a part of building a quality management system in a global, high-growth company. As a Quality Assurance Manager, your main responsibility is to improve and maintain our Quality Management System and lead the Clinical Laboratory Quality Team. You will take care of clinical laboratory certifications and accreditations and ensure that our processes are in compliance with relevant customer and regulatory requirements. As a subject matter expert, you will have a key role in supporting and training several teams across the organization.
Your main tasks will include:
- Leading the Clinical Laboratory Quality Team
- Managing the clinical laboratory Quality Management System (QMS)
- Managing computerized QMS systems
- Overseeing the maintenance of certifications and accreditations
- Organizing and supporting risk-based vendor evaluation and qualification
- Supporting R&D and Production teams in product/service and process specification development
- Supporting equipment qualification and method validation activities
- Monitoring quality indicators
- Organizing clinical laboratory QMS reviews
- Organizing clinical laboratory-related quality training
- Coordinating clinical laboratory-related process changes
- Communicating QMS-related issues to personnel and management
- Maintaining the annual audit plan of clinical laboratory QMS
- Organizing and supporting internal and external audits, including vendor audits
- Overseeing nonconformity and CAPA processes in the clinical laboratory
- Overseeing the periodic review of relevant clinical laboratory legislation
What we expect from you
We are looking for someone who is enthusiastic about quality management and ready to take ownership of the tasks at hand. You thrive in a fast-paced environment and manage to prioritize and tackle complex issues. Our ideal team member is flexible and solution-driven, with an entrepreneurial mindset and excellent communication skills. We hope you enjoy collaborating with others and helping your team to prosper.
Our ideal candidate has:
- A BSc and/or MSc from the field of life sciences or engineering
- 3+ years of experience in clinical laboratory quality management, preferably in a manager/supervisor role
- Strong leadership and interpersonal skills
- Excellent communication skills in English, both spoken and written
- Strong problem-solving skills
- A solid understanding of applicable regulations and industry standards regarding clinical laboratory, including ISO 15189. Knowledge of US clinical laboratory regulations, NY CLEP and CAP, 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 work with dedicated and innovative experts with versatile backgrounds, whilst having an opportunity to support industry-changing solutions that improve the lives of patients and families affected by inherited diseases. We offer you an open and positive work environment where you can learn and grow together with the company. You will join a collaborative and agile team of five quality and regulatory experts.
If you are up for the challenge, please apply latest on Monday, May 10. 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: firstname.lastname@example.org or by phone +358 40 846 8833 on April 22 at 13-16 (EET).