Job Title: Quality Assurance Manager (Responsible Person)i+solutions
Reports to: QA Manager
Location: Woerden, Utrecht, Netherlands (Hybrid)
We dream of a world where no medical need goes unmet. Suffering or dying because of a lack of medicines is inhumane. That’s why we do whatever it takes to create better access to medicine for people around the globe. Our job is done when every person on this planet has access to the right medication & medical supplies at the right place and time. And we know how.
Since 2005, i+solutions has set the industry standard for health procurement. We drive an innovative agenda to improve global health supply chains. We combine procurement, training, project management, quality assurance and technical expertise to make a difference from the first to the last mile, closing the gap between patients and medicine.
Big dreams ask for big solutions. That’s why we work with global donors, countries and partners to make a difference daily. These partnerships enable us to scale our solutions, drive industry innovation, and conquer new challenges. Together, we combine big hearts with big data to improve supply chains that secure accessibility and care.
We’re here to close the gap. And together, we can!
The role of QA Manager is key within our organization. As we are a relatively small and purpose driven organization, The role is broad and touches several organizational areas. The QA Manager is responsible to build and maintain the Quality Management System (QMS), perform internal and external GDP, ISO and WHO-MQAS related audits, risk management, CAPA and incident management. In this role you help the access to medicine and other health products such as medical devices to all that are in need of them through ensuring a continuous supply of good quality medicine and quality health products.
Perform internal and external GDP, ISO and WHO MQAS audits GDP related CAPA and incident management
- Support the organization in the creation of Standard Operating Procedures and other QMS documentation
- Handle the risk management process
- Support on the preparation of Management Information (MI) and reports for discussion with (senior) stakeholders.
- Support and participate in quality assurance related projects and/or continuous improvement working groups.
- Ensure i+solutions QMS compliance with GDP
- Act as Responsible Person on the WDA for i+solutions
- Be informed on all regulatory and quality assurance related developments in line with ISO9001, GMP, GDP and the WHO model quality assurance system for procurement agencies.
- Keep accurate documentation and be on the lookout for opportunities for improvement and develop smart and efficient procedures.
- Cultivate a culture of quality, risk and compliance at i+solutions by leading by example and holding fellow staff accountable.
- Bachelor’s or Master’s degree in life sciences or other relevant field or equivalent experience, preferably a pharmacist.
- Be eligible to act as Responsible Person to a WDA under EU GDP.
- Experience conducting GDP and ISO related audits.
- Experience with CAPA and incident management
- Experience in Quality Assurance within the health sector, pharmaceutical industry or pharmaceutical logistical service provider.
- Experience in people management.
- Good understanding of regulatory and quality requirements for Pharmaceutical products.
- Excellent oral and written communication skills, proficient in MS Office.
- Fluency in English is required, competence in Dutch and any other language is highly valued.
- Knowledge in the field of NGO’s and preferably international development or the humanitarian world is a plus.
- Enthusiastic team player and able to demonstrate integrity in all dealings with colleagues, customers, regulators and other professionals.
- Pro-active approach and problem-solving skills.
- Open minded and able to build strong, open dialogue-based relationships with relevant stakeholders.
- Action oriented with a strong focus on completing tasks accurately and efficiently
- Risk-based mindset with an ability to understand consequences of actions both internally and externally.
- The ability to act in an international field of stakeholders effectively at all levels, both internal and external.
What we offer
- Working in a great team and a pleasant atmosphere.
- A drive for purpose and a multi-cultural environment.
- Teaming with professionals that put passion into our Mission.
- Good compensation package and excellent opportunities for personal development.
- 30 days holiday, Pension contribution 55%, Commuting allowance.
Values and background check
i+solutions has a zero-tolerance policy against sexual exploitation and abuse.
i+solutions may conduct background and reference checks on applicants who accept job employment offers.
Please apply with your CV and cover letter telling us why you think you would be a great fit for this position email@example.com