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Quality and Regulatory Compliance Leader
Quality and Regulatory Compliance
warehousing, third party, logistics (GDP)
About Our Client
Our client is a world wide leader in developing Medical Devices and Pharmaceutical products. Their strength lies in the ability to develop, produce and distribute a broad portfolio of state of the art products on a world wide scale. Secondly they have a unique strong code of conduct in being full compliant to the high ethical standards and full compliance with all applicable laws and regulations tailored per specific country or market in which they perform their activities.
The Quality Assurance and Regulatory Assurance group directs company wide efforts to assure that processes applied in the company are state of the art, efficient and meet regulatory requirements. That products and services meet regulatory requirements of the countries where they are marketed or used in clinical studies. The team provides leadership in quality system management, monitor and advise for quality aspects of products, processes and systems. Therefore they need someone that is independent, quality focused, and a proactive player in business processes. For this role we are looking for someone with a strong focus on result. A person that is proactive with a high level of integrity that works as a team player.
The main tasks and responsibilities are:
- Being a Responsible Person for warehousing and distribution activities of Pharmaceuticals products at the GDC
- Maintaining the pharmaceutical wholesalers license, the tissue establishment license, the Device Foreign Exporter registration and the ISO-13485 certification of the GDC
- Being responsible for coordination of field safety corrective actions of all items distributed by the GDC facilities
- Ensuring regulatory compliance at the GDC by a.o. Quality System Documentation, training and project management
- Aligning with manufacturers for regulatory aspects to manage their products at the GDC; eg non-conformities, quality holds, local rework, etc.
- Being responsible for coordination of Supplier Quality Assurance for non-product vendors at the GDC.
The Successful Applicant
- Bachelor or Master degree within a relevant field (Pharmacy, Biotechnology, Biology, Bio-engineering, Quality)
- Minimum of 5 - 10 years experience with Quality and Regulatory in a Medical device or Pharmaceutical Organisation
- Experienced in communicating with Competent Authorities and Notified Bodies
- Several years of managerial experience
- Strong communication skills with a fluency in English
What's on Offer
- Excellent salary package and secondary benefits
- Great company to work for
- Many growth and personal development opportunities