The Head of Quality is accountable for the functional area of quality. The Head of Quality is responsible for the company’s global strategic direction, development, implementation and operational management of all Quality Assurance activities related to the Design, Development, Manufacturing, Testing, Release and Customer related process for Biocartis Products.
He/She will serve as the key point of contact representing Quality in various governance bodies and is accountable for proper liaising with various regulatory agencies for quality related matters.
He/She is an expert in one or more domains of quality. He/she leads the strategy development and operational aspects of the functional area quality and is accountable for Biocartis' processes owned by the functional area quality, and manages the financial objectives of the functional area quality.
The Head of Quality is accountable for all people management aspects within the functional area of quality. He/she ensures that the quality teams are equipped with strong people, and is accountable for the team’s talent and competence management.
He/She is an active and visible change agent, exposing inspirational leadership across the team to achieve the Biocartis goals in the immediate and longer term.

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

• Ensure that quality system requirements are effectively established and effectively maintained in accordance with applicable standards and regulations. Ensures maintenance of the applicable QMS certification.

• Ensure that products that are developed, manufactured, released, distributed and services at/from all Biocartis facilities consistently comply with the policies, procedures, work instructions and specifications as covered by the Quality Management System. Accountable for strategic development of the functional area to serve short-, mid- and long-term business needs, and the implementation thereof.

• Acts within joint accountability as the Person Responsible for Regulatory Compliance (Article 15; IVDR regulation) Person Responsible for Regulatory Compliance in accordance with IVDR, article 15, paragraph 1-4, specifically for the responsibilities defined in sub-paragraph 3 a and 3 c:

a) the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released.
c) the post-market surveillance obligations are complied with in accordance with Article 10(9);”, which states: “Manufacturers of devices shall implement and keep up to date the post-market surveillance system in accordance with Article 78”.

• Champions the development and maintenance of a Quality Culture within Biocartis.

• Accountable for leading all operational aspects of the function while continuously striving for performance improvement and effectiveness. This includes but is not limited to:

i. audits from partners, customers, Regulatory authorities and notified bodies;
ii. timely release of components and Biocartis products to agreed specifications and in compliance with approved regulatory files.

• Accountable for ensuring best-in-class resource, on-time and in-scale (human) resource availability according to short-, mid- and long-term business demands.

• Accountable for ensuring best-in-class performance of the quality management functional area.

• Accountable for ensuring streamlined interfaces (e.g. processes) of the functional area quality management to other functional areas involved in the quality management process.

• Accountable for financial objectives and annual budgets of the functional area quality.

Resource and competence management

• Ensures lean organizational approach while continuously striving for minimum overhead of the functional area without compromising its effectiveness.

• Creates an environment of strong team spirit, sense of urgency and high motivation within the team.

• Accountable for staffing decisions including hiring, promotions and termination by evaluating performances of employees.

• Is an inspirational coach and mentor for the team, encouraging job satisfaction and people’s personal growth; enhances professionalism.

• Maintains the quality competence management and succession plan in line with team and business needs.

• Empowers the Functional Leads to represent the functional area across all phases of the product/service lifecycle, from development, into manufacturing product launch and commercialization and eventually to product/service retirement.

Process ownership

• Ensures compliant, efficient & effective quality processes, i.e. processes owned by the functional area Quality, meeting the different Business and Function Area needs,

• Is considered as the most senior spokesperson within Biocartis representing the Quality Organization both internally and externally. Represents the organization during audits.

• Ensures appropriate problem solving within the functional area and projects, and escalation when needed.

• Acts as a change agent, leads organizational or departmental change processes when necessary.

In specific, he/she will execute upon the following responsibilities:

• 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,

i. ensuring that quality system requirements are effectively established and effectively maintained in accordance with respective standards and regulations;
ii. reporting to top management on the effectiveness of the quality management system and any need for improvement;
iii. ensuring the promotion of awareness of applicable regulatory requirements and quality management system requirements throughout the organization.

• Provide leadership to the QA teams in all Biocartis facilities;

• Ensure a smooth interface with notified bodies, and key regulatory agencies such as FDA on quality related matters, in close collaboration and consultation with the Regulatory Affairs Function.

• Serve as the key point of contact representing Quality in various governance bodies.

• Lead financial objectives and annual budgets of the functional area quality.

• Ensure lean organizational approach while continuously striving for minimum overhead of the functional area without compromising its effectiveness.

PROFILE REQUIREMENTS
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.

Software and database applications
MS Office (Excel, Power Point, Word and Outlook)
Legislation and regulation
ISO 13485 and CFR 820 deep knowledge
Languages
Fluent in English (written and spoken), any other European language is considered an asset.

Our offering
We offer you a truly exciting job in a senior leadership role in a fast growing international and innovative environment where you can work with top entrepreneurs in the biotech industry. You can be part of a very dynamic, young and growing team. You will have freedom to shape your work and shape your job where you deem it necessary: we value your input.
Of course we offer you an appropriate compensation package which includes a Flexible Income Plan & a hybrid way of working (partly in the office, partly from home) to maintain a healthy work/life balance.