Overview
Join Our Team as a Senior Manager, Quality Assurance (GCP Auditor) - hybrid in Warsaw, Poland / Lund, Sweden or home based in Italy or Portugal.
About this role
As part of our Quality and Compliance team you will work alongside passionate and innovative professionals to ensure our customers achieve their goals. The Senior Manager, Quality Assurance (GCP Auditor) is responsible for the quality oversight of the GCP activities related to clinical trials. The Senior Manager performs day-to-day clinical quality operations and compliance activities to support the success of the clinical trial projects. The primary responsibility is to ensure that clinical processes are conducted in accordance with applicable regulatory requirements, ICH Guidelines (e.g., ICH E6 GCP), Standard Operating Procedures and country-specific requirements, along with current industry standards and practices.
The Senior Manager, Quality Assurance (GCP Auditor) facilitates the generation and revision of the Controlled Documents (e.g., Policies, SOPs); supports the Risk Assessment, Root Cause Analysis (RCA) and Corrective Action Preventive Action (CAPA) Plan generation for Quality Issues (QIs); drives the completion of the relevant quality sections of RFP / RFI quality assessments; assists with GxP Computer System Validation (CSV); prepares, conducts and follows up on all types of GCP / GxP internal and external audits, including hosting external audits and conducting activities to ensure inspection readiness.
This person has experience in clinical research and quality assurance and is able to provide support and advice throughout this area.
Key Responsibilities
AUDIT
- Prepares, conducts and follows up on all types of internal and external GxP audits
- Supports and provides leadership in clinical audit activities for both internal and external parties to ensure alignment with TFS standards, regulatory requirements, and quality expectations
- Works closely with Business Leads to ensure appropriate and timely resolution of audit findings / non-compliant issues, quality investigations, etc.; approves corrective action and preventive action (CAPA) plans as required
- Conducts peer review of audit reports
- Supports and guides operational staff in preparing for customer audits
INSPECTION
Prepares investigational sites for regulatory inspections, as requiredGuides operational staff in preparing for inspections, including risk analysis and developing inspection readiness strategyActs as a subject matter expert for inspectors and ensures Business Unit team members are prepared for interactions; provides training / preparation to the backroom support teamManages the team during inspectionsHosts and manages regulatory inspections for clients, as requiredQUALITY MANAGEMENT SYSTEM
Facilitates teams in generating / updating Controlled Documents; drives processes to ensure documents align with regulatory requirements and applicable standardsSupports staff to complete risk assessments and root cause analysis for all Quality Issues, ensuring timely completion and client-ready documentationAssists staff to prepare robust CAPA Plans, track and manage to completionContributes to continuous improvement of the organization and development of routines to increase quality and complianceCLIENT INTERACTIONS
Assists with business development of external quality and compliance servicesLeads / attends client visits or meetings when requiredSUPPORT
Provide quality advice and support to internal and external clientsLeads clinical non-compliance investigations and CAPA implementation, including monitoring non-compliance trends and effectiveness checksIdentifies potential systemic gaps and coordinates with stakeholders to ensure timely remediation; escalates critical non-compliance issues to Head of Quality and Compliance as appropriateQualifications
University / college degree in a scientific area (Italy : Life Science degree level education is required)Awareness of the clinical trial area in the CRO / pharma industry, including knowledge of GCP / GxP regulationsDeep understanding of GCP / GxP regulations and standards to interpret findings of auditsAt least five (5) years’ experience in clinical trials, including quality assurance and quality operations; CSV knowledge / experience is a plusAdheres to ethical and good clinical practices; able to work as part of a team and independently in a remote environmentExcellent interpersonal and communication skills and ability to manage multiple projects with timelinesHighly analytical with attention to detailPro-active, problem-solving mindset with ability to develop solutionsGood planning, organization and problem-solving abilities; able to multitask and prioritizeExcellent written and verbal English skillsAdvanced user of MS Office (Outlook, Word, Excel, PowerPoint)(Italy) Compliance with Italian MoH Decree dated 15 November 2011; we welcome applications from protected categories under art. 1 L. 68 / 99What We Offer
We provide a competitive compensation package, comprehensive benefits, and opportunities for personal and professional growth in a rewarding environment. You’ll be joining a team that values collaboration, innovation, and making a difference in the lives of patients.
About Us
Our journey began over 29 years ago in Sweden, in Lund. As a full-service global Contract Research Organization (CRO), we deliver tailored clinical research services in more than 40 countries with flexible clinical development and strategic resourcing solutions. Our core values are Trust, Quality, Passion, Flexibility, and Sustainability.
Together we make a difference.
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