- responsible for the clinical quality department
- temporary contract from Derks & Derks Secondment & Interim for 6 months with the possibility to extend the contract
- position for 32 to 40 hours a week
Our client is an international pharmaceutical company. The company’s activities comprise the development, production and sales of medicines. For the facility in Leiden we would like to meet an enthusiastic, communicatively skilled, self-assured and performance-oriented Director Clinical Quality.
As Director Clinical Quality you will lead the Clinical (research) Quality Assurance project and programs. Therefore you will be responsible for developing the strategy and execute the direction for the department, programs and projects. You will keep contact with medical and development stakeholders locally, regionally and globally. You will direct the development, approach and implementation to ensure and effective audit and oversight program which complies with regulatory requirements and stakeholder expectations. Your leadership provides to the drive of development, communication, implementation, maintenance and execution of standards and processes within the function and you will communicate with relevant stakeholders. You will work together with your team by managing and directing the Clinical QA staff. Together you will continuously evaluate strategic approach, drive changes in the audit program to meet changing needs of the organisation, regulatory environment and industry best practices. You will assure the creation and implementation of the appropriate strategic risk-based support model for each project. Furthermore you will ensure the development of short and long-term risk-based quality strategies in support of M&D development programs based on current regulatory interpretations, and drive their implementation locally and globally as appropriate. It is needed to collaborate within CRQA and M&D functions to establish the global audit and oversight program. Furthermore you will provide strategic direction to ensure that the appropriate processes and procedures are in place for C(R)QA. You will also be responsible for forecasting and managing the assigned budget for the CQA group as part of the overall CRQA budget. And you will manage and grow the CQA resources as appropriate through effective recruitment, performance management, development planning and retention.
- bachelor’s degree
- minimum of 7 years working within a regulated environment such as Regulatory, Quality, Pharmacovigilance or Clinical Development or Operations
- expert knowledge of the pharmaceutical and/or CRO industry, pharmaceutical R&D processes and global regulatory agencies, regulations and procedures
- proven experience with GCP Quality Management Systems and quality support and oversight of global clinical trials and drug development operations
- minimum of 3 years of significant experience in quality assurance
- minimum of 3 years people/project management experience, preferably in a highly matrixed, multicultural global setting, requiring facilitation, negotiation, problem-solving, and conflict resolution skills
- in-depth understanding of GCP requirements for both marketed and investigational products
- extensive practical experience and understanding of clinical quality assurance as applied throughout the entire pharmaceutical compound/product life cycle
- proficiency in Microsoft Office.
Interested? Please send your resume and motivational letter by email, with reference number DT/18-162-DD to Office@derksenderks.nl. For further information, please call Sandra van Putten at number +31 (0)33 472 80 87. An individual assessment may be part of the selection procedure.