Clinical QA Auditor / Sr. Clinical QA Auditor - EU (SP36HM178)

The Aixial Group is an International Contract Research Organization (CRO), a member of the ALTEN Group, with offices located in France, UK, US, Belgium, Denmark, Sweden, Switzerland, Romania, and India.

The CRO occupies a unique position in the clinical research industry, supporting biotech in clinical trials across all phases (Ph. I - IV) and non-interventional studies, as an expert in the operational delivery of clinical trials. Our vision is to conduct clinical trials better than anyone else, to help patients and ultimately save lives. We have earned a strong reputation for successfully delivering complex, demanding and innovative clinical trials, with specialist therapeutic expertise in oncology, cell & gene therapy, radiopharmaceuticals and rare diseases.

We are currently looking for a Clinical Quality Assurance Auditor / Senior Clinical Quality Assurance Auditor. This is a full-time permanent role and can be home-based in EU where we have the ability to hire.

Responsibilities

1. Ensures that the Clinical Quality Assurance System meets the expectations of the GCPs and other applicable GxPs and follows an inspection readiness and continuous improvement approach at AIXIAL Group level.
2. Actively participate in the development and planning of the annual audit program.
3. Implements and coordinates internal quality control/audit activities at local and international level.
4. Participate in the writing of Compliance Plans (quality plan, internal audit plan and training plan) on an annual basis and updates them as necessary.
5. Coordinates the management of non-conformities with the teams and verifies the effectiveness of actions taken within the expected timeframes.
6. As lead auditor, plans and conducts internal and external audits.
7. Coordinate and follow-up of CAPAs for customer audits, Regulatory Inspection, internal and vendor audits.

Quality Management System

1. Improve and manage the clinical quality assurance system program to ensure compliance with regulatory requirements, company standards, and industry best practices.
2. Oversee the development and maintenance of Standard Operating Procedures (SOPs) and ensure they are consistently followed.

Clients Audit & Inspection

1. Manages aspects related to the preparation of customer audits/Inspections with relevant teams.
2. Follow up customer audits and be responsible for inspections within the deadlines set by customers or inspectors.
3. Oversee the implementation of CAPAs, check that corrective and preventive actions are carried out on schedule by acting as the main contact with the teams or subcontractors concerned, and ensure that the actions implemented are documented.

Internal and Vendor Audit

1. Independently conduct Audits that can include Clinical Investigator Site, Vendors, internal process audit, GCP/GxP Document Audits (ICFs, CSR and Trial Master Files).
2. Develop audit plans, and audit reports, and track audit findings to resolution.
3. Assist with corrective and preventive action plans (CAPAs) to assure follow-up and implementation of corrections for internal and external audits.
4. Oversee the maintenance of records for each audit.

Regulatory Compliance

1. Ensure the regulatory monitoring and stay current with regulatory changes and updates.

Noncompliance and Continuous Improvement

1. Lead/manage CAPAs elaboration, follow-up and closure.

Vendor Oversight

1. Ensure the referencing process of new vendor according to the steps of questionnaire evaluation, risk level identification and selection of vendor to be evaluated.
2. Coordinate the annual assessment of vendors, in compliance with procedures, applicable regulations and the company's quality policy.
3. Identify and approve vendors to be audited following the risk assessment.

Training

1. Participate in the review or production of training materials and provide employee training on quality, procedures, and regulations.

Work Experience, Qualifications and Knowledge:

1. Minimum of 8-10 years of experience in clinical quality assurance.
2. Auditor certification or relevant experience to demonstrate the capacity to act as an auditor with prior GCP/GCLP/GVP auditing.
3. Extensive experience conducting clinical audits and a deep understanding of GCP guidelines and regulatory requirements (FDA, EMA, ICH).
4. GCLP/GVP Knowledge.
5. Degree level in a Life Sciences or related discipline or appropriate experience.
6. Previous experience of Clinical Quality Assurance in the Pharmaceutical and/or CRO sectors.
7. Excellent analytical, problem-solving, and decision-making skills.
8. Knowledge of risk-based monitoring approaches.
9. Excellent communication and interpersonal skills, with the ability to interact effectively with all levels of the organization and external stakeholders.
10. This position may require occasional travel to clinical sites, vendor locations, and regulatory meetings.

Technical Skills

1. Good knowledge of Microsoft Office 365 and use of SharePoint.
2. eQMS, LMS knowledge is a plus.

Languages

1. Fluent English is required.