Senior Quality Manager

4 settimane fa

Roma, Italia Tfs Healthscience A tempo pieno

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.

Join Our Team as a Senior Quality Manager - home 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 & Compliance team you will working alongside passionate and innovative professionals to ensure our customers achieve their goals.

The Senior 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.

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
- Actively contribute to continuous improvement of the organisation and development of routines to enhance the work at TFS

COMPUTER SYSTEMS VALIDATION:

- Assists with all aspects of CSV for all systems across the company

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 especially in the CSV field
- Excellent interpersonal skills
- CSV knowledge and experience preferable
- 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 a competitive compensation package, comprehensive benefits, and the opportunity 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

A Bit More About Us

Our journey began over 25 years ago in Sweden, in the city of Lund. As a global CRO with the ultimate goal of ensuring patients’ safety and well-being, we provide biotechnology and pharmaceutical companies with tailored clinical development solutions. We currently operate in 17 countries across Europe, North America, Asia Pacific and the Middle East.

Our core values of Trust, Quality, Flexibility and Passion are what make TFS Healthscience the successful company it is today. Our values shape our culture and work ethic. They reflect what we stand for and guide our organization.

#Together we make a difference

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