QA manager global clinical processes

Ref. 20180828
Function: You are responsible for managing and harmonizing the Company’s global clinical trial processes and systems.
Location: Operating from Ghent, willingness to travel abroad (4 times a year, trips from 2 days up to 5 days).

The company:

The Company's laboratories routinely conduct medical clinical testing, thus ensuring that the tests offered are also performed on a daily basis for diagnostic purposes, patients stratification, staging, therapeutic indication and follow-up.
Equipped with cutting-edge technologies, the Company's medical and scientific experts are specialists in their academic field for delivering more than just testing. At the Company, they act as genuine partners with our customers. We encourage that our scientists are integrated in our client’s R&D processes, thus providing a critical advantage in the ever increasing complex setting of clinical trials.

Job description:

Work with local and global teams to ensure that operational processes meet regulatory requirements and are aligned with current business practice and evolving organizational structure. He/she is responsible for managing and harmonizing the Company’s global clinical trial processes and systems. For these processes he/she is responsible for ensuring global compliance, CAPA management and continuous audit readiness resulting in seamless clinical results reporting to sites and sponsors.

• The Global Clinical Processes Manager is responsible for defining, describing and optimizing the procedural framework for the different operational processes for clinical trials and will facilitate the harmonization of processes/procedures across the Company’s affiliates and departments globally
• Ensure compliance to global clinical trial processes, lead and/or participate in improvement projects that enable the Company to conduct clinical trials in an efficient and compliant manner
• Drive continuous improvement and compliance of global processes through the design and periodic review of metrics and key performance indicators. He/she is responsible for the organization and conduct of the periodic Management Review
• Lead process improvements and efficiencies including development and management of CAPA and facilitation of Root Cause Analysis
• The Global Clinical Processes Manager will lead or participate in the harmonization of the Company’s global departmental processes and tools to improve departmental work, consistency and global compliance
• Acquire in-depth knowledge of the Clinical Trial Management System and ensure compliant use of the system and procedures by all parties involved
• Manages adequate review and analysis of incoming issues for clinical trials, follow-up and tracking of ongoing CAPA’s from internal/external audits from the Company’s global operations
• The Global Clinical Processes Manager will create high level process maps for all the clinical development processes running on the Company’s system for all functional teams involved
• Create a clear overview and relational diagram of key processes, key process owners, documents and owners and authors for the global clinical organization
• Establish and maintain a RACI model that can be applied for new global trials
• Audits
• Prepare, plan, organize and host Sponsor audits for the Company’s clinical trials at other facilities including follow-up of resolution plans
• Perform Audits of the Company’s partner labs or vendors as set out in the yearly audit plan
• Act as the backup for other QA Manager(s)/QA Director for the Company’s clinical operations.

Requested competences and skills:

• MSc degree with experience in quality and compliance related field(s)
• Extensive experience within a QA environment and good knowledge of GCP is a must. Knowledge of GLP and QMS standards (e.g. ISO15189) is preferred;
• Strong and effective interpersonal skills
• Experience with documentation systems, document review and auditing responsibilities is required. Ability to interpret data to develop action plans to improve business
• Must be highly detail-oriented. Strong verbal and written communication skills, as well as strong interpersonal and influencing skills are required
• Be a pragmatic and solution and solution-oriented team player with the ability to motivate colleagues and stakeholders
• Experience with lean principles, six sigma and Risk Management is preferred
• Willingness to travel (8 times a year, trips from 2 days up to 5 days) to the Company’s affiliates
• Fluent in English and Dutch. French is a plus.


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