i-Pharm Consulting

Clinical Quality Director

Location
Paris
Salary
100,000+
Posted
05 Dec 2018
Closes
19 Dec 2018
Ref
DAWHQA2
Contract Type
Permanent
INTRODUCTION

i-Pharm Consulting are working exclusively with a mid-sized pharmaceutical company who require an experienced Clinical QA professional to join their team as a Clinical Quality Director. This permanent opening will see you assume the position of SME for all operational GCP Compliance, Quality and Governance matters for organisation, as well as commercial and strategic responsibilities.

JOB SUMMARY

* Exciting pharmaceutical company
* Established clinical portfolio and exciting therapeutic developments
* Autonomous working, high level of role ownership
* Opportunity to take the lead on commercial activities
* Opportunity to define overall global QA business strategy
* Highly competitive remuneration

TITLE

* Clinical Quality Director

LOCATION

* Office-based, Paris

RESPONSIBILITIES

* Responsible for the development, implementation and continuous improvement of quality systems to the global company
* Take the lead on EMA and FDA inspections, providing guidance and expertise to the existing quality structure
* Manage the overall clinical auditing function for the global business
* Development, implementation and continuous improvement of a robust QMS system
* Development, maintenance and continuous improvement of Risk Management procedures
* Responsible for efficient and effective QA documentation plans
* Work closely with Clinical Operations and leadership teams to remain fully informed with any quality issues
* Reviewing overall quality systems' performance against developed metrics

REQUIREMENTS

* Relevant Life Sciences degree
* 10+ years' clinical QA roles within CRO/Pharma/Biotech environment
* Strong knowledge and experience of EMA and FDA guidelines
* Proven leadership experience
* Fluency in both French (mother tongue desirable) and English
* Excellent communication skills, both orally and written
* Certified ASQ Auditor (ASQ Quality Engineer certification desirable)

About i-Pharm Consulting

i-Pharm Consulting is a specialist Recruitment Company servicing the Pharmaceutical industry in the UK and Europe. We provide both permanent and contract staff to a wide range of Pharmaceutical, Medical Device, Biotechnology and Contract Research Organisations (CROs). i-Pharm has specific expertise in Clinical Research, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Quality Assurance, Validation and Bioinformatics.
www.i-pharmconsulting.com

TO APPLY

If you would like to discuss this vacancy further, please call Senior Consultant Dominic Williams on +44 (0)20 3873 7066, or email dwilliams@i-pharmconsulting.com. If this role is not suitable, Dominic is also available to discuss other possible positions or answer any general questions regarding your career and the current market.

KEY WORDS

CAPA / Quality Systems / QMS / Audit / Auditor / GxP / GDP / GCP / SOP writing / SOP / SAE / Quality Assurance / QA / QA specialist / QA Manager / Quality Assurance / QA Leader / Quality Manager / Senior Manager / Senior Management / Pharmaceutical / Site Audit / Internal Audit / External Audit / ICH-GCP / Good Distribution Practice / Risk / Risk Management / General Data Protection Regulations / GDPR / E6 (R2) / Clinical QA / CQA / Root Cause Analysis / RCA / England / Wales / Scotland / Ireland / London / Paris / France / Lyon / Versailles / Meaux / Cergy / Troyes Orleans / Le Mans / Rouen / Amiens

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