Senior Quality Manager - Lund, United Kingdom - TFS HealthScience

Description

TFS HealthScience is a leading global midsizeContract Research Organization (CRO) that partners withbiotechnology and pharmaceutical companies throughout their entireclinical development journey. Our expertise includes fullservicecapabilities resourcing and Functional Service (FSP)solutions.

JoinOur Team as aSeniorQuality Manager home based in UK orItaly.

Forcandidates based in Italy we welcome applications from candidatesbelonging to protected categories under art. 1 L.68/99

Aboutthis role

As part of ourQuality &Compliance team you will workingalongside passionate and innovative professionals to ensure ourcustomers achieve their goals.

TheSenior QualityManagerfacilitates the generation andrevision of all Quality Management System (QMS) Documents; supportsthe risk assessment Root Cause Analysis and Corrective ActionPreventive Action (CAPA) Plan generation for all Quality Events;drives the completion of relevant quality sections of Request forProposal (RFP)/ Request for Information(RFIs)/quality assessments;assists with the Computer System Validation (CSV) of all systemsacross the company; prepare conduct and follow up internal andvendor audits and the management of the resultant CAPA; assistswith hosting externalaudits.

This person hasexperience in clinical research and quality assurance and is ableto provide support and advice throughout thisarea.

RFIs:

• Providesinput into the quality section of RFI / RFP and qualityassessments; maintains a library of questions and robust agreedanswers

AUDIT:

• Prepareconduct and follow up on internal GxPaudits
• Prepare conduct and follow up on vendoraudits
• Support and guide operational staff inpreparing for customer audits
• Assist withhosting client audits asappropriate

INSPECTION:

• Assistwith supporting and guiding operational staff in preparing forinspections including analyse risks and develop inspectionreadiness strategy
• Assist with preparation andmanaging the backroom supportteam

QUALITY MANAGEMENTSYSTEM:

• Facilitates teams from acrossthe company in generating / updating any QMS Documentation; drivingthe process to ensure no QMS documentexpires
• Supports staff from across the companyto complete accurate and detailed risk assessments and root causeanalysis for all quality events ensure all are completed on timeand documentation is always suitable to share with clients asappropriate
• Assists staff to prepareappropriate and robust CAPA Plans (for Quality Events) and trackand managing these through to completion ensuring most CAPA arecompleted on the due date
• Actively contributeto continuous improvement of the organisation and development ofroutines to enhance the work atTFS

COMPUTER SYSTEMSVALIDATION:

• Assists with all aspectsof CSV for all systems across thecompany

SUPPORT:

• Providequality advice and support to internalclients

MISCELLANEOUS:

• Preparesand presents training asappropriate
• Participate in internal meetings asrequired and liaise with other departments asnecessary
• Maintain required knowledge ofapplicable regulations and company GxP standards andprocedures
• Other tasks and activities delegatedby the Senior Director Quality Management or Associate DirectorQuality Operations within scope ofexperience

Qualifications:

• University/collegedegree or equivalent industryexperience
• Awareness of the clinical trialsarea / pharma industry including knowledge of GxPregulations
• Two years experience in clinicalresearch especially in the CSV field
• Excellentinterpersonal skills
• CSV knowledge andexperience preferable
• Highlyanalyticalprofessional with strong attention todetail
• Proactive recognizing and anticipatingissues addressing problems and developing solutions
• Good planning organisation and problemsolvingabilities
• Demonstrated ability to multitaskprioritize and complete objectives
• Excellentoral and written communication skills
• Fluent inEnglish both written and verbal
• Advance user ofMS Officeapplications

What WeOffer

We provide a competitivecompensation package comprehensive benefits and the opportunity forpersonal and professional growth in a rewarding environment. Youllbe joining a team that values collaboration innovation and making adifference in the lives ofpatients

A Bit More AboutUs

Our journey began over 25 yearsago in Sweden in the city of Lund. As a global CRO with theultimate goal of ensuring patients safety and wellbeing we providebiotechnology and pharmaceutical companies with tailored clinicaldevelopment solutions. We currently operate in 17 countries acrossEurope North America Asia Pacific and the Middle East.

Our core values of Trust Quality Flexibility andPassion are what make TFS Healthscience the successful company itis today. Our values shape our culture and work ethic. They reflectwhat we stand for and guide ourorganization.

#Together we make adifference