Responsible for ensuring the robustness and effectiveness of our Quality Management System (QMS) governing the clinical research activities. This includes:
- Assuring all systems, processes and their outcomes comply with applicable international and national regulations and guidelines and fulfill clients requirements.
- Executing internal and vendor audits, participating in client and regulatory inspections, and/or managing the administration and reporting aspects of quality management systems.
- Serving as quality consultant to the organization, acting as a resource for training activities and policy-making decisions, supporting business leaders in mitigation of risk, and responsible to build relationships between on-site QA services and QA management of designated clients.
· Quality Initiatives:
- Support the Director Training and QA in establishing a clearly defined QMS that is robust and effective in ensuring regulatory compliance.
- In collaboration with operational departments, support the development of written procedures (SOPs) that ensure compliance with applicable regulatory requirements and industry standards.
- Investigate and report on deviations. Ensure effective root cause analysis is performed and adequate CAPA plans are defined and implemented in a timely manner.
- Identify process improvements opportunities and foster a culture of quality.
- Lead internal quality focused meetings and/or projects.
- Can be assigned as QA consultant on client QA projects depending on the required technical expertise and experience.
- Stay up to date with current trends, knowledge and development and proactively identify opportunities to update and increase knowledge and share with others.
- Maintain and build a professional network.
- Attend meetings and conferences, as required.
· Advice & Expertise:
- Develop training materials and/or deliver training related to quality matters, as assigned, and in collaboration with the Director Training and QA.
- Provide guidance and support to project teams on the pragmatic interpretation of GxP, SOPs, quality and regulatory requirements.
- Help develop and maintain quality management related metrics to help us understand how it is performing with respect to quality.
- Support the Director Training and QA managing the internal QA audit program.
- Plan and conduct programmed and contracted audits.
- Ensure audit reports meet internal/external quality standards and timelines.
- Support our employees in the follow-up of audit findings and implementation of agreed CAPA plans.
- Liaise with sponsor auditors and regulatory inspectors on the follow-up of findings and the implementation of agreed CAPA plans.
- Support the Director Training and QA in the evaluation and trending of audit and inspection findings.
Master’s degree in (para-) medical sciences or equivalent by experience.
- Minimum 5 to 10 years clinical research experience in a pharmaceutical company, CRO or regulatory body and at least 5 years’ experience in Quality Management;
- Minimum of 2 years’ auditing experience in GCP.
- Detailed knowledge of ICH GCP E6 R2, EMA directives 2001/20/EC + Device directive, EMA regulations (device and clinical trials), FDA regulations FDA CFR part 11, 50, 54, 56, 312, 820 and ISO 14155;
- Proficient in Microsoft Office (Outlook, Word, Excel, and Power Point);
- Being very knowledgeable about all aspects and phases of clinical research.
Skills and Competences
- Demonstrate sense of responsibility, integrity, diplomacy and confidentiality.
- Ability to be flexible and to adapt and work effectively with a variety of situations or individuals.
- Gives advice, acts as a consultant for complex projects, leads, manages and directs others.
- Very strong interpersonal skills and the ability to build relationships with stakeholders, including staff, Management Team and external partners;
- Demonstrated ability to effectively and persuasively communicate verbally and in writing.;
- Demonstrated proactive approaches to problem-solving with strong decision-making capability;
- Emotional maturity;
- Highly resourceful team-player, with the ability to also be extremely effective independently;
- Sensitive to cultural differences.
- Fluent in Dutch, French and English.
CONTACT for more information:
jobs [at] qbd [dot] eu
03 844 45 01