Quality Management Systems Manager
The world is facing a medical crisis, bacteria are increasingly evolving resistance to even our strongest antibiotics. The problem is already very real and immediate; for example, bloodstream infection leading to sepsis is now responsible for more than half (>52%) of all deaths in hospitals and is the most expensive condition treated in hospitals. Yet, despite the life and death urgency, and healthcare cost impacts, current methodologies require 3 days to determine the correct antibiotic. Since, without effective antibiotic treatment sepsis mortality rate increases >6% every hour, 3 days is far too long to wait for a life and death treatment.
Specific Diagnostics has developed a breakthrough solution to rapidly determine the effective antibiotic treatment. Used for bloodstream infection Specific’s Reveal system provides results 2 days sooner (1 day vs 3 days). The result is lifesaving. Since sepsis is the most expensive condition treated in hospitals the market is very large.
We offer an opportunity to join us at an inflection point in our commercial growth, with our first commercial product being released, new venture capital funding and recognition from major customers and government agencies fueling an expansion of our staff.
As the Quality Management Systems (QMS) Manager you’ll drive the development and implementation of the company’s quality management systems, to ensure operational excellence is maintained across all elements of product development, distribution, supply chain and on market support. You will work closely with functional departments and key stakeholders to strengthen and improve quality system and drive efficient and effective compliance to regulatory requirements.
You have defined, or in an existing company, fully grasped how “the system” works. A great QMS leader has broad and deep expertise, including Design Controls, owns the system, understands the system from user perspective and gets the fundamentals of the compliance of the underlying the system. You have a proven track record of successfully, architecting, developing, and auditing to solve challenging real-world applications, in challenging QMS environments. You should be excited by the prospect of working in a dynamic, entrepreneurial environment and the following qualifications:
You try to always meet the agreed timelines and quality objectives. Therefore, you collaborate closely with the assigned areas of operation.
To ensure the development and maintenance of effective quality documents, you collaborate with the assigned areas of operation, and you liaise with other areas/departments for cross functional topics to be addressed and created accordingly.
You facilitate and follow up on client audits and regulatory inspections, always in close collaboration with the QA Director. You also provide leadership and training to operations colleagues in case of these audits and inspections.
You’re the ‘light in the dark’, you guide the responsible persons in performing adequate Root Cause Analysis. You help them with defining and implementing adequate and compliant Corrective Action and Preventive Action (CAPA) Plans for reported deviations.
You will analyze and discuss trends in reported deviations and their impact. When needed you will report to the senior management.
You interpret new or updated regulations and guidelines, policies and procedures as necessary and provide interpretation and consultation to your colleagues regarding these topics.
You carry out the Specific Diagnostics ‘culture of quality’. When process improvement opportunities present themselves in both the operations or QA area, you identify and promote them. You develop training materials and/or deliver training to assure quality awareness all around.
Technical Areas of Competence, Skills, and Behavior:
- University Degree in sciences, or an equally recognized degree. Relevant qualifications by experience may also be acceptable and will be evaluated on a case-by-case basis.
- A ‘track-record’ of at least 5 years’ experience in a medical devices or similar company.
- Strong project management and people management skills in a matrix environment.
- Excellent written and spoken English. Knowledge of other languages is a plus.
- Good interpersonal communications skills.
- Ability to handle several complex projects or initiatives simultaneously.
- What’s a team without a team player? You love to work in team and can handle stress like a pro, thanks to your well-organized competences.
- A quality mindset and a big interest for customers; with a good sense of diplomacy and confidentiality.
- Cognizant with (inter)national guidelines and regulations related to clinical research and ability to make decisions based on appropriate interpretations.
- Experience with an electronic document management system, then this is a big plus, since one of your responsibilities will also include the management oversight of the electronic document management system and the reviewing of the work of the QMS administrator.