MidFull TimeEN
About this role
TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full-service capabilities, resourcing, and Functional Service (FSP) solutions.
The Quality Manager is a position in the Quality Systems or Quality Operations Teams, Quality & Compliance Department.
The Quality Manager facilitates 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; prepare, conduct and follow up internal and vendor audits and the management of the resultant CAPA; assists with 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
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 internal GxP audits.
Prepare, conduct and follow up on vendor audits.
Support and guide operational staff in preparing for customer audits.
Assist with hosting client audits, as appropriate.
INSPECTION:
Assist with supporting and guiding operational staff in preparing for inspections including analyse risks and develop inspection readiness strategy.
Assist with preparation and managing the backroom support team.
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.
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 and in the CSV field
Excellent interpersonal skills
Highly-analytical professional with strong attention to detail
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
What We Offer
We provide opportunities for personal and professional growth in a rewarding environment. You will join a team that values collaboration, quality, and making a difference in the lives of patients.
Our core values of Trust, Quality, Passion, Flexibility, and Sustainability guide our decisions and shape our culture. By aligning on these values, we foster collaboration, innovation, and a shared commitment to excellence. Together, we make a difference.
A Bit More About Us
Our journey began over 30 years ago in Sweden, in the city of Lund. As a full-service global CRO, we build solution-driven teams working toward a healthier future. Bringing together over 600 professionals, TFS delivers tailored clinical research services in more than 50 countries, offering flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology.
