Head of Quality

at  Biocartis

Publication date
21 August 2024
Location
Mechelen
Country
Belgium
Workplace type
Hybrid
Travel percentage
5%
Function type
Full-time
Contract type
Employee

Experience required

• Minimum 15 years of experience in healthcare industry of which minimum 10 years in Quality.
• Profound experience of medical device and/or In Vitro diagnostics development and manufacturing in FDA regulated environment. (PMA level products).
• Solid experience with FDA inspections.

Education
Academic level in engineering, chemistry, pharmacy or equivalent through experience.

ACCOUNTABILITIES

The role includes, but is not limited to, the following accountabilities:

EDUCATION

Academic level in engineering, chemistry, pharmacy or equivalent through experience.

EXPERIENCE

• Min. 15 years of experience in healthcare industry of which min. 10 years in Quality.
• Profound experience of medical device and/or In Vitro diagnostics development and manufacturing in FDA regulated environment. (PMA level products).
• Solid experience with FDA inspections.

TECHNICAL/THEORETICAL KNOWLEDGE, SKILLS AND EXPERTISE

• Experience in the medical devices and/or in the IVD industry;
• Experience with US regulatory applications, as well as Europe; Asia is a plus;
• Experienced at maintaining focus on the bigger picture whilst also maintaining detailed analysis as and when required;
• Confidence to make decisions and assist others in doing so, even when complex and difficult;
• Hands on mentality;
• Thrives in a fast paced and changing environment;
• Proven leadership capabilities with a track record of managing across different disciplines within areas of high risk, uncertainty and familiarity with the specific needs of molecular and diagnostics programs;
• Proven leadership ability to carry out difficult decisions in a logical, rational manner, and demonstrated ability to work as a management team member and to engage and influence team members in a matrixed environment;
• Excellent communication skills to share the strategy, deliverables and action plans of all projects;
• Able to drive forwards all quality management visions and initiatives and align them with the requirements of business and regulatory requirements;
• Strong business acumen: thorough understanding of e.g. P&L, NPV;
• Excellent presentation and business writing skills.

• Provide strategic leadership for the company’s Quality Management System in accordance with worldwide (EU, US, and ROW) regulatory requirements;
• Act as management representative conform ISO13485 and 21CFR820