Senior Quality Manager Quality Manager

TFS HealthScience is a leading global midsize Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full servicecapabilities resourcing and Functional Service (FSP) solutions.

Join Our Team as a Senior Quality Manager / Quality Manager home / office based in the UK Italy Spain or Poland.

For candidates based in Italy we welcome applications from candidates belonging to protected categories under art. 1 L. 68/99.

About this role

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

The Senior Quality Manager / Quality Managerfacilitates the generation and revision of all Quality Management System (QMS) Documents; supports the risk assessment Root Cause Analysis and Corrective Action Preventive Action (CAPA) Plan generation for all Quality Events; drives the completion of relevant quality sections of Request for Proposal (RFP)/ Request for Information(RFIs)/quality assessments; assists with the Computer System Validation (CSV) of all systems across the company; prepares conducts and follow up with on all internal and external audits and the management of the resultant CAPA; hosting external audits

This person has experience in clinical research and quality assurance and is able to provide support and advice throughout this area.

Key Responsibilities:

COMPUTER SYSTEMS VALIDATION:

• Manage and lead all quality aspects of CSV and IT Security within TFS.
• Prepare conduct and follow up on internal and external CSV / Computerised Systems audits including system/process audits vendor audits
• Mentor and train Quality Managers in CSV and IT Compliance as appropriate

CLIENT INTERACTIONS

• Assist with business development of external quality and compliance services
• Lead / attend client visits / client meetings when required

RFIs:

• Provides input into the quality section of RFI / RFP and quality assessments; maintains a library of questions and robust agreed answers

AUDIT:

• Prepare conduct and follow up on all types of internal and external GxP audits
• Peer review of audit reports
• Support and guide operational staff in preparing for customer audits
• Hosting client audits

INSPECTION:

• Preparing investigational sites for regulatory inspections as required
• Guide operational staff in preparing for inspections including analyse risks and develop inspection readiness strategy
• Provide training/preparation to the backroom support team; manage team during inspections
• Host and manage regulatory inspections for clients as required

QUALITY MANAGEMENT SYSTEM:

• Facilitates teams from across the company in generating / updating any QMS Documentation; driving the process to ensure no QMS document expires
• Supports staff from across the company to complete accurate and detailed risk assessments and root cause analysis for all quality events ensure all 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 Events) and track and managing these through to completion ensuring most CAPA are completed on the due date
• Actively contribute to continuous improvement of the organisation and development of routines to enhance the work at TFS

SUPPORT:

• Provide quality advice and support to internal clients

MISCELLANEOUS:

• Prepares and presents training as appropriate
• Participate in internal meetings as required and liaise with other departments as necessary
• Maintain required knowledge of applicable regulations and company GxP standards and procedures
• Other tasks and activities delegated by the Senior Director Quality Management or Associate Director Quality Operations within scope of experience

Qualifications:

• University/college degree or equivalent industry experience
• Awareness of the clinical trials area / pharma industry including knowledge of GxP regulations
• Two years experience in clinical research (GCP) especially in the CSV and IT securityfield
• Excellent interpersonal skills
• CSV and IT securityknowledge and experience is mandatory
• Highlyanalytical professional with strong attention to detail
• Proactive recognizing and anticipating issues addressing problems and developing solutions
• Good planning organisation and problemsolving 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

What We Offer

We provide a competitive compensation package comprehensive benefits and the opportunity for personal and professional growth in a rewarding environment. Youll be joining a team that values collaboration innovation and making a difference in the lives of patients

A Bit More About Us

Our journey began over 27 years ago in Sweden in the city of Lund. As a fullservice global Contract Research Organization (CRO) we build solutiondriven teams working towards a healthier future. Bringing together over 800 professionals TFS delivers tailored clinical research services in more than 40 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology Neuroscience Oncology and Ophthalmology.

Our core values of Trust Quality Passion Flexibility and Sustainability are our guiding light serving as the framework for decisionmaking at all levels of the organization. They assist us in attracting and retaining valuable talent who share our sentiments resulting in high employee engagement and satisfaction. By aligning on these fundamental values we cultivate a unified force geared towards innovation and excellence. This collective effort propels us towards our shared goal and fosters a culture of mutual respect and collaboration. Together we make a difference.