Senior Manager eCompliance - Global Clinical Quality Assurance (Yacht Life Sciences)
Yacht Life Sciences has a vacancy for a Senior Manager eCompliance - Global Clinical Quality Assurance at our client, a science-led global healthcare company.
As a Senior Manager eCompliance you will develop and maintain the Global eCompliance oversight function for Computerized Systems in the GCP-regulated area to ensure that all aspects of such systems comply with GCP regulatory requirements and the Quality Standards for computerized systems validation. Furthermore, you will represent eCompliance as an integrated function within R&D and Quality.
As a Senior Manager eCompliance you will act as the main Quality contact for questions on regulatory compliance of Computerized Systems and Data Integrity in Clinical Development activities. Also, you will provide guidance and leadership to improvement projects involving Computerized Systems in the GCP area.
As a Senior Manager eCompliance you will review, evaluate and approve Computerized Systems related to quality and validation documents as appropriate. Furthermore, you will support and may take a lead role in regulatory inspections or internal audits that involves computerized systems used in Clinical Development. In addition, you will stay abreast on current GxP and regulatory requirements for Computerized Systems and proactively ensures ongoing organizational awareness to changes in such regulations and impact, (if any) on any new or current systems.
As a Senior Manager eCompliance you will support and/or take part in organizational or cross-functional initiatives involving data integrity and you may be part of a project team that supports such activities. Next, you will keep senior management abreast of eCompliance and related data integrity quality issues and/ or progress by routinely reporting status to senior management.
As a Senior Manager eCompliance you will support oversight of external providers to ensure they meet expectations per established Quality Standard regarding the use of computerized systems. Finally, you will hire, assign and manage contractors supporting project specific Quality oversight of computerized systems validation and change control, if applicable.
- University Degree
- Relevant experience along with experience in the pharmaceutical industry (at least 8 years)
- Fluent in written and spoken English
- Strong knowledge of GCP regulations and Clinical Quality Management
- Strong knowledge of and experience in Computerized Systems Validation processes
- Excellent communication and interpersonal skills are required to operate within constantly expanding and changing environment
- Strong leadership skills and commitment to results
- Excellent PC skills and good written and verbal communication
To be discussed with our client where the candidate will be appointed.
The vaccines, medicines and consumer healthcare products that they research and develop can improve people’s health and well-being, ultimately helping them to live life to its fullest and contribute to the prosperity of their communities.
Voor meer informatie neem je contact op met Edwin Parlevliet via telefoonnummer +31 0612387998
Werken voor Yacht
Yacht is dé organisatie van en voor professionals. Wij verbinden professionals en organisaties die het verschil willen maken. Ons doel is optimaal resultaat: jou als professional uitdagend werk bieden waarmee jij de organisaties van onze opdrachtgevers blijvend verbetert. Behoor jij tot de beste professionals in jouw vak? Wil je samen met vakgenoten het verschil maken bij toonaangevende organisaties? Dan willen we jou graag leren kennen.
Uiteraard staat deze vacature open voor zowel mannen als vrouwen.