Senior Manager, Quality Assurance

TFS HealthScience

Warsaw or Lisbon

About this role:

As part of our Quality and Compliance Department team you will working alongside passionate and innovative professionals to ensure our customers achieve their goals.

The Senior Manager, Quality Assurance is responsible for the quality oversight of the GCP activities related to clinical trials. The Senior Manager, Quality Assurance 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 the 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 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 the Quality Issues (QIs); drives the completion of the relevant quality sections of Request for Proposal (RFP)/Request for Information (RFIs)/quality assessments; assists with the GxP Computer System Validation (CSV); prepares, conducts and follow up with on all types of the GCP/GxP internal and external audits, including hosting external audits and conducting activities to ensure inspection readiness.

Key Responsibilities:

QUALITY MANAGEMENT SYSTEM:

Facilitates teams from across the company in generating/updating Controlled Documents; driving the process to ensure Controlled Documents are aligned with the regulatory requirements and the applicable standards;
Supports staff from across the company to complete accurate and detailed risk assessments and root cause analysis for all Quality Issues, ensure they are completed on time and documentation is always suitable to share with clients as appropriate;
Assists staff to prepare appropriate and robust CAPA Plans (for Quality Issues), track and manage these through to completion ensuring the CAPAs are completed on the due date;
Drive and actively contribute to continuous improvement of the organisation and development of routines that aim to increase quality and improve compliance.

INSPECTION:

Prepares investigational sites for regulatory inspections, as required;
Guides operational staff in preparing for inspections including analyse risks and develop inspection readiness strategy;
Acts as a subject matter expert for inspectors and ensuring the Business Unit team members are fully prepared for interactions; provides training/preparation to the backroom support team;
Manages team during inspections;
Hosts and manages regulatory inspections for clients, as required.

AUDIT:

Prepares, conducts and follow up on all types of internal and external GxP audits;
Supports and provides leadership in clinical audit activities for both internal and external parties (e.g., service providers, clinical sites) to ensure alignment with TFS standards, regulatory requirements, and quality expectations;
Works closely with Business Leads to ensure/coordinate appropriate and complete resolution of audit findings/non-compliant issues, quality investigations, etc. in a timely manner, including approval of corrective action and preventative action (CAPA) plans, as required;
Conducts peer review of audit reports;
Supports and guides operational staff in preparing for customer audits;
Hosts client audits.

CLIENT INTERACTIONS:

Assists with business development of external quality and compliance services;
Leads/attends client visits/client meetings when required.

SUPPORT:

Provide quality advice and support to internal clients and external clients;
Leads clinical non-compliance event investigations and CAPA implementation that may include monitoring non-compliance trends and effectiveness checks;
Identifies potential systemic gaps and coordinates with the appropriate stakeholders to ensure timely remediation. As appropriate, escalates issues of critical non-compliance and/or lack of urgency in remediation to the Head of Quality and Compliance.

Qualifications:

University/college degree in a scientific area;
Awareness of the clinical trial area in the CRO and/pharma industry, including knowledge of GCP/GxP regulations;
Deep understanding of GCP/GxP regulations and standards to facilitate the interpretation and impact of findings of internal and external audits;
At least five (5) years’ experience in clinical trials, including quality assurance and quality operation experience. trials. CSV knowledge and experience are a plus;
Adheres to ethical and good clinical practices and the ability to work as part of a team. As well as work independently in a remote workforce environment;
Excellent interpersonal and communication skills and the ability to work on multiple projects with competitive timelines are required;
Highly analytical professional with strong attention to detail and respect for the need for accuracy of information;
Pro-active, recognizing and anticipating issues, addressing problems and developing solutions;
Good planning, organisation and problem-solving abilities;
Demonstrated ability to multitask, prioritize, and complete objectives;
Excellent oral and written communication skills;
Fluent in English, both written and verbal;
Advance user of MS Office applications (Outlook, Word, Excel, PowerPoint).