QA-GCP/GLP Expert

Overview

Purpose: Ensure that a QMS is implemented and maintained to support GCP/GLP activities

Responsibilities

- Be the QA representative of the Clinical and non-Clinical departments.
- Ensure that a QMS is implemented and maintained to support GCP/GLP activities, together/in close cooperation with R&D department.
- Drive and maintain an appropriate level of compliance to the QMS.
- Ensure the management of DEV, CAPA, CC and RR in the area of expertise. In particular, take part, review, support and approve related documents, with a solution driven mindset.
- Participate in the writing, reviewing, approval of QMS documents (risk assessments, training records, SOPs,…) in the area of expertise.
- Ensure the management of suppliers/subcontractors/clinical vendors and CROs for the related stakeholders (Clinical operations, Clinical Development, Product Management & Leadership, Non-clinical development): selection, risk-based assessment, audit, approval/ qualification, follow-up, periodic review/re-qualification:
- Manage the quality agreements (or any other type of contract covering quality requirements)
- Manage/plan/coordinate the audits and follow-up on CAPAs.
- Lead/participate in audits of key suppliers/subcontractors/clinical vendors and CROs.
- Manage/coordinate the complaints towards suppliers/subcontractors/clinical vendors and CROs.
- Manage KPIs, quality trend analysis and periodic quality review of suppliers/subcontractors/clinical vendors and CROs.
- Ensure that critical issues are adequately and timely escalated.
- Act as the QA representative whenever cases of suspected fraud, misconduct and other serious breaches are reported.
- Provide expert ICH-GCP compliant advice on clinical matters to clinical study teams and/or clinical vendors when consulted by the clinical study team members.
- Be involved in and support continuous improvement in the area of expertise
- Ensure inspection/audit readiness in the area of expertise
- Ensure internal and external audits in the area of expertise
- Provide training to the teams on quality topics
- Remain up to date with the latest industry changes related to GCP, provide consultancy on GCP quality and compliance related issues to clinical study teams.
- Follow training as needed to fulfill function requirements

Qualifications

Minimum Bachelor's degree in a scientific or life sciences field. Healthcare background and/or advanced degree preferred. Minimum 10 years of experience in Biotech/Pharmaceutical Industry in GCP quality role, clinical monitoring or equivalent, with at least 5 years in quality.
Familiarity with global GCP regulations, Good Clinical Practices, ICH Guidelines and Good Laboratory Practices.
Must have clinical trial audit experience.
Demonstrated audit conduct experience is required, including supporting regulatory authority inspections.
Ability to compile and interpret quality metrics.

Honest
Rigorous
Assertivity
Proactive
Solution oriented
Well organized

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