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Senior Manager, Quality and Regulatory

By August 10, 2021August 25th, 2021No Comments

FOx BIOSYSTEMS is a young Belgian scale-up on a mission to revolutionize the life sciences and pharmacological research market with innovative real-time, label-free analysis products. The basis of our success is a novel fiber-optic-based surface plasmon resonance biosensor that enables our users to generate high-quality biomolecular data accurately, fast, cost-effectively, and in a broad application area.

We currently employ about 15 people in our offices in Diepenbeek, Belgium. We will be expanding rapidly over the coming months, and we are looking for ambitious professionals to join our team.

Job Description

The Sr Manager, Q&R will develop and implement the company’s quality, regulatory and compliance policy. Together with the COO, he/she will own the further development of our QMS processes and be the central point of authority when it comes to adhering to quality and regulatory standards.

Key responsibilities

  • Formulate, implement, and maintain quality policy, tools, and reports
  • Ensure compliance to regulations for target markets as needed, by setting requirements
  • Ensure that products comply with all the relevant safety and environmental policies
  • Ensure key quality management system processes are run fully, efficiently, and in a timely manner
  • Recommend and implement changes to drive continual improvements
  • Drive Q&R awareness and culture within the company
  • Partner with other senior staff to establish strategic plans and objectives
  • Make final decisions to ensure the achievement of the company’s business objectives with full quality and regulatory compliance
  • Control planning, budgeting, and managing expense priorities for Q&R projects

Education and work experience

  • Master’s degree in life science or an engineering discipline with at least 7 years of related work experience in life sciences (academia, biotech, pharma) or the medical device industry
  • Solid understanding of appropriate global laboratory and medical device regulations, requirements, and established quality standards
  • Certified ISO 9001:2015 and/or 13485:2016 lead auditor
  • Demonstrated successful implementation and certification of Quality Management Systems to ISO 9001 and/or ISO 13485 standards
  • Experience in the field of analytical equipment or IVD is a plus
  • Certification as Lean Six Sigma Green Belt a plus
  • Full professional proficiency in Dutch and English is required

FOx BIOSYSTEMS recruits based on core values, leadership attributes, and proven expertise. The company believes in the equal importance of personality and the ability to deliver.

Your profile

  • Natural change leader: Pragmatic, strong organizational skills, and motivator for others to follow
  • Enthusiastic and engaging presenter with excellent verbal and written communication skills, providing feedback and pinpointing improvements where needed
  • Able to envision a Big Picture but with a keen attention to details
  • Sense of ownership and pride in own performance and impact on the company’s success
  • Committed to continuous improvement
  • Enjoys working in a growing and changing environment
  • Able to work well and collaborate within a team environment

When you work for FOx BIOSYSTEMS, you have a customer-centric focus, also when the customer is your direct colleague. We are proactive and pragmatic. We look for colleagues with a proven track record so we can give them the independence and freedom to be successful in their line of work.

To apply, please send your resume to: careers@foxbiosystems.com