|Title:||Manager of GCD - Europe Quality Assurance|
|Job Status:||Full Time|
Celerion is the leading global provider of outsourced early clinical research services.
Celerion is looking for a
Manager of GCD - Europe Quality Assurance (m/f)
In this hands-on role, the Manager of GCD - Europe Quality Assurance will perform and provide day-to-day support, guidance, and supervision for the quality assurance functions for Global Clinical Development - Europe (GCD – EU) in the Vienna, Berlin and Paris facilities.
- Responsible for the development of annual auditing programs for GCD-EU auditing functions, in accordance with Celerion’s procedures, policies, and applicable regulatory requirements and local laws.
- Responsible for QA management and resourcing of GCD-EU auditing and QA functions
- Responsibilities include planning, performing, assigning and oversight of QA work; development, review and approval of local QA auditing documents; further development and growth of QA functions; training GCD auditors; coaching of GCD-EU employees, as applicable.
Day-to-Day Quality Assurance Activities:
- Primary contact for support to GCD – EU operations, including QA and regulatory consulting and assistance with trouble-shooting, regarding GCP issues/matters.
- Perform and provide guidance on internal and external audits.
- Primary contact for GCD-EU study auditing; site/study documents, study data and study reports to ensure compliance with protocols, procedures, and applicable regulatory requirements, guidelines and local laws.
- Assure management that study audits, audits of site study data and final reports, and audits on internal systems and facilities are in compliance with company policies, procedures, and regulatory requirements, guidelines and local laws.
- Review audit reports to ensure the results accurately reflect the study data and documents generated during the study.
- Ensure documentation of study-specific and procedural deviations is complete
- Participate, monitor, evaluate and oversee follow-up on quality issues, and corrective and preventive actions.
Vendor, Investigator Site, System-based and Study Audits (external and internal audits):
- Perform and oversee vendor (external supplier) qualification/cyclic audits and investigator site audits, in accordance company procedures and/or contractual obligations.
- Perform and oversee internal system-based audits and study-specific audits, issue the audit findings in a written report, and follow-up on findings to closure.
Quality Management System:
- Primary contact for support to GCD – EU operations
- Lead and participate in the review of Global and GCD SOPs and/or the writing of QA/QMS SOPs, as required, ensuring that local GCD – EU and QA SOPs are in line with Global SOPs.
- Drive quality process improvement, lead and participate in quality initiatives and internal QA projects
- Perform and oversee quality issues resolution and CAPA effectiveness evaluations
- Monitor and ensure training record maintenance
- Lead/participate in GCD Quality Council Meetings
Client/Sponsor Audits and Regulatory Authority Inspections:
- Host and facilitate the preparation, conduct and follow-up of client/sponsor audits and regulatory authority inspections.
- Act as the QA partner and coordinate the action items/QIs/CAPAs and finding responses for client/sponsor audits and regulatory authority inspections.
- Ensure regulatory inspection readiness, through appropriate QA auditing and support of GCD-EU
- Bachelor’s degree in science or similar
- Minimum of 5 years of GCP QA experience (no GLP or GMP only candidates)
- 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
- Client/Sponsor Audit and Regulatory Authority Inspection experience a plus
- 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
Position Location: Office based in Vienna, Austria (preferred) or Berlin, Germany
Start: As soon as possible