Head of GCD Quality Assurance - EU
|Title:||Head of GCD Quality Assurance - EU|
|Job Status:||Full Time|
Head of GCD Quality Assurance - EU (m/f)
The Head of GCD Quality Assurance - EU will provide day-to-day guidance, supervision and support for the quality assurance functions for Line of Service (LOS) Global Clinical Development Europe (GCD - EU) and QA staff/functions in Vienna, Berlin and Paris facilities.
- Responsible for QA staff management in accordance with the Celerion's policies and applicable laws. Responsibilities include interviewing and training GCD auditors; planning, assigning, performing and directing work; approval of local QA auditing documents, appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems; development and coaching of employees.
Quality Management System:
- Primary contact for support to GCD operations
- Ensure local QA SOPs are in line with Global QA SOPs
- Drive quality process improvement initiatives.
- Oversee quality issues resolution
- Oversee and facilitate the preparation, execution and follow-up of client/sponsor audits and regulatory authority inspections.
- Coordinate the action items/QIs/CAPAs and responses for client/sponsor audits and regulatory authority inspections.
- Oversee and perform vendor (external supplier) qualification/cyclic audits, internal systems-based audits and study-specific audits, issue the audit findings in a written report, and follow-up on findings to closure.
- Primary contact for auditing of study reports, site/study documents, and study data to assure compliance with protocols, procedures, and applicable regulatory requirements and guidelines.
- Ensure audit reports to assure the results accurately reflect the study data and documents generated during the study.
- Assure management that audits of study phases, audits of site study data and final reports, and audits on internal facilities are in compliance with company policies, procedures, and regulatory guidelines.
- Lead and participate in the review and/or the writing of SOPs, as required.
- Provide guidance for and perform internal and external audits.
- Participate, monitor and evaluate follow-up on quality issues, corrective and preventive actions.
- Perform other functions as assigned by Global QA management
- Bachelor’s degree in science or similar
- Minimum of 5 years of GCP Phases IIb, III, & IV QA experience (no GLP or GMP only candidates will be considered)
- Pharmaceutical/device clinical research industry experience
- Supervisory/management experience
- Proficient knowledge of GCP/cGLP/cGMP, ICH Guidelines E2A, E6, & E8, European Directives on GCP, as well as local regulatory authority regulations
- Regulatory Authority Inspection experience
- Excellent oral and written communication skills
- Excellent organization, prioritization and problem-solving skills
- Computer proficiency in MS Office (other software a plus)
- Fluency in English
Start: As soon as possible