Senior GCP Quality Management Specialist - Belgium
The Ablynx QA Department is looking for a Senior Quality Management Specialist GCP. He/she will be part of the GCP QA team responsible for supporting the implementation of an integrated quality management (QM) system and for improving the current QM processes of Ablynx.
- Set-up and maintain the quality management system in accordance with internal and external (inter)national standards and guidelines.
- Provide quality support of projects, incorporating a risk-based approach.
- Help implement the ICH GCP processes throughout the company.
- Identify ways to continuously improve quality and compliance with regulations and company policies, procedures and standards through partnership with the different Ablynx clinical departments.
- Produce/implement audit plans, oversee/perform project related audits and follow up on quality issues.
- Audit protocols, Clinical Study Reports and Submission Documents for GCP and regulatory acceptance.
- Perform internal audits to verify the compliance of the Ablynx Quality Management System. Provide quality and compliance guidance for the development and implementation of the corrective and preventive actions and monitor their status and timely closure.
- Perform all types of GCP, GVP, GCLP (process, sites, Clinical Labs, Clinical Supplies, Diagnostic Labs, DM, reports), vendor and due diligence audits to assure that processes used and/ or data generated meet all quality standards, regulations and Ablynx requirements.
- Guarantee the follow-up of the corrective action/ preventive actions and continuous evaluation of third parties.
- Establish written agreement with third parties defining the quality requirements. Coordinate and review CAPAs from both audits and quality issues to ensure adequate root cause analysis and systemic solutions are performed.
- Conduct trend analyses of audit results and provide feedback to higher management and internal customers.
- Lead formal investigations of issues overseeing timely resolution and escalation to line management and regulatory authorities of critical observations that constitute GCP breaches.
- Assess new systems before implementation.
- Develop and deliver training for different levels of auditor skill requirements.
- Training on GCP/ ISO and root cause analysis for auditors, operational employees and investigators/investigator site personnel.
- Provide advice on GxP matters.
- Ensure inspection readiness by preparing the clinical departments for regulatory inspections; provide inspection management support and follow-up post-inspection.
- Provide support in preparation of and act as spokesperson during audits and regulatory inspections.
- Represent QA in interactions with internal and external contacts and with Health Authorities.
Education: Master or PhD in a relevant field of life science with minimally 10-15 years of experience as GCP QA.
Experience and professional requirements:
- Thorough knowledge of international GCP regulations including FDA GCP, ICH GCP, new drug/biologics regulations, current industry practice, pharmacovigilance.
- Understanding on how GCP relates to and interacts with the other GxP areas.
- Vision on QM and combination of analytical skills with process thinking.
- Display excellent verbal and written communication skills.
- Skilled at conflict resolution and negotiation.
- Possess excellent problem-solving and decision-making skills.
- Capable of working independently but also being able to function as part of a cross-functional team.
- Demonstrating the ability to influence.
- Being flexible to change priorities in a dynamic, fast moving business environment.
- Sense for initiative, quality, accuracy and detail.
- Excellent knowledge of English both in reading and writing.
Please make sure your attached CV contains a paragraph containing your technical expertise.