Our client is a leading global biopharmaceutical company. They are seeking a Senior Compliance and Process Associate to be home or office based in France, Spain or Germany.
The Senior Compliance & Process Associate will provide professional expertise, guidance and strong leadership in GCP to proactively identify compliance issues/risks in all clinical studies and registries within the organisation and its external partners.
PRINCIPAL RESPONSIBILITIES include:
Serve as an expert resource and provide technical direction and compliance guidance;
Provide guidance on country specific educational publications, presentations and Phase IV study conduct;
Serve as an advisor for QA related issues;
Create an effective, collaborative environment to develop and motivate staff to excel as compliance professionals;
Support implementation of collaborative quality management system;
Identify process improvements across the organisation;
Research, develop and maintain policies and procedures on GCP compliance;
Support the creation and implementation of internal and external audit programs.
QUALIFICATIONS, KNOWLEDGE & EXPERIENCE:
Degree in a scientific field;
Experience in GCP compliance/QA in pharmaceutical or biotech industry;
Oversight of international compliance with applicable regulations for Ph I-IV and Medical Affairs activities;
Work experience in internal and external compliance auditing;
Experience working in Quality management Systems;
Experience in training initiatives and management
PERSONAL SKILLS & ATTRIBUTES:
Excellent interpersonal, written and verbal communication skills
BENEFITS: This company is seeking talented, motivated and team oriented individuals who are keen to make a difference. They offer highly competitive salaries and comprehensive benefits which include: pension, health, company relocation, stock options on joining, and annual bonus.
Fforde is acting as a recruitment agency/business.
KEY WORDS: Compliance, Pharmacovigilance, Regulatory Affairs, Risk Management, QA, Legal, Research & Development, Quality, GCP, Pharmaceutical, Biotech, Medical Affairs, Auditing, Auditor, France, Germany, Spain, Home Based, Europe