Vacancy: Quality Assurance Manager
What are your responsibilities?
- You are 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.
- You take 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.
- You give advice and use your 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.
Who are we looking for?
- You have a master’s degree in (para-) medical sciences or equivalent by experience.
- You have 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;
- You have minimum of 2 years’ auditing experience in GCP.
- You have 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;
- You are proficient in Microsoft Office (Outlook, Word, Excel, and Power Point);
- You are very knowledgeable about all aspects and phases of clinical research.
- 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.
- 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.;
- Highly resourceful team-player, with the ability to also be extremely effective independently;
- Fluent in Dutch, French and English.
What does the QbD group offer you?
QbD is a healthy company with a strong growth and international ambitions. In addition to a very attractive salary package, we can offer you the following advantages:
- Our CEO, Bart Van Acker, became Flemish Young Entrepreneur of the year 2019, which means that you’ll be part of a vibrant, entrepreneurial organization.
- A company with a clear strategy and ambition
- We've got your back! Our HR Business Partners follow you closely, giving you the opportunity to shape your career.
- Thanks to our flat organization, we have short communication lines and you can always come to us.
- Standing still means going backwards. With our extensive training package and our periodic knowledge-sharing moments, we offer you many opportunities to continuously learn, to expand or specialize your knowledge and skills and to gain new expertise.
- Get to know your colleagues outside the work environment! Teambuilding and fun activities are planned on a monthly basis. A comedy night or quiz night? Nothing is too crazy for us!
- In short… We stand for JPEG: Joy in Partnership, going for the Extra mile to Get things done!
Interested? Send us your CV and motivation letter and who knows, we might welcome you soon in our QbD family!