- manage the QA department at an international company
- a lot of personal responsibility and flexibility
- part of a dynamic and diverse team, where personal development is crucial
Our client is focused on improving peoples live with their healthcare products. They are dedicated to their commitments to patients, health care providers, other stakeholders and society. Their goal is to build an innovative company committed to advancing global health. A broad range of branded and generic pharmaceuticals, OTC products and medical devices is being manufactured and marketed all around the world.
Their Dutch office is based in the Amsterdam region and the culture at their office can best be described as informal, open and accessible. Currently they are looking for a driven and experienced Head of QA EMEA.
As a Head of QA EMEA you manage the Quality Management Systems for our client, Third Party Logistic distribution sites and Commercial Affiliates in EMEA. Besides this you will ensure distribution sites and commercial affiliates comply with (Inter)national legislation for the distribution of pharmaceutical and medical device products, cosmetics, food and food supplements.
Your responsibilities include the definition, implementation and maintenance of efficient and effective quality systems for our client and Third Party Logistic distribution sites and commercial affiliates. You assure that the quality system is compliant with associated regulations and effectiveness metrics are being utilized. Besides this you will ensure effective Supply Chain services to our clients business units. This is achieved by driving continuous assessment and improvement of the processes within the quality system aimed at achieving stated business goals and objectives. Furthermore you ensure that short and long range quality plans, goals, annual operating plans and budgets are aligned and achieved. Other tasks may include managing and assisting in audit activities, including corporate, business units, MOH, and other notified bodies. But you will also perform Due Diligence audits at new distribution sites and logistics service providers. You monitor the Quality Management Systems and report to EMEA management periodically on audit results, corrective action and performance. And you will recommend improvements to Quality Management Systems.
As a Head of QA you partner with Third Party Logistic vendors to improve their quality systems and assure Quality Agreements with all involved partners of the EMEA region remain up to date. But you will also partner with Business Units on Quality issues and improvement programs. Besides this you will ensure compliance with relevant regulations including, Quality System Regulation, Medical devices directive, cGMP and GDP regulations and Country specific regulations.
- Pharmacist or Bachelor’s/ Master degree in Engineering or Related Science Field or equivalent
- 6-10 years quality assurance experience, with a minimum of seven years management experience in medical device and/or pharmaceutical environment
- experienced with FDA, EU Medical Device Directive, Pharmaceutical Quality System Regulations and GXP requirements (GDP, GMP)
- analytical, financial and budgeting skills
- team building skills
- broad business perspective
- ability to develop a vision and lead change
- effective verbal and written communication skills and interpersonal skills
- leadership and influencing skills
- ability to manage people, departments and functions
- ability to work with minimal supervision
Interested? Please send your resume and motivational letter by e-mail, with reference to WS/19-039-DD, to Djamila Hagemans : firstname.lastname@example.org.
For further information, please call Djamila Hagemans at number +31 (0)33 472 80 87.
An individual assessment may be part of the selection procedure.
Our Client has chosen Derks & Derks B.V. as recruitment agency for this assignment. We request therefore to send any application or other response to Derks & Derks.