Global Head of QA and RA - Med Dev & Pharma - Sydney

JOB TITLE

Global Head of Quality and Regulatory Affairs - Sydney based - Full Time

JOB SUMMARY

A Global Head of Quality and Regulatory Affairs is required for a pharma and medical devices company.

The company is going through some really positive transition globally from Sydney meaning they need a strong performer in this role.

There will be manufacturing and production on site and expansion happening over a short space of time across the globe. This expansion will be driven from Sydney HQ

This role will be to take on Regulatory and Quality.

ROLE/DESCRIPTION

• Broad based Quality Management role supporting management
• stand in for the manager when they are overseas on signing off on business docs / decisions
• Maintain Quality Management system in line with ISO13485, GMP
• hand in some strategic input
  21CFR820 and other standards relevant to the design, development, manufacture and distribution of a product.
• Document Control
• Support the Head of Quality Assurance and Regulatory Affairs
• Manage submissions for local and coordinate affiliates
• FDA and Medsafe and TGA liaison
• Configuration Management
• Provide oversight on CA/PA related activates

REQUIREMENTS

• Life sciences degree (pharmacy preferred)
• Extensive experience in Australian Regulatory Affairs (and New Zealand ideally)
• Experience with TGA, Medsafe and ideally the FDA
• Line Management to a medium sized team
• Global Regulatory Programs
• Extensive ISO 13485 knowledge
• People management would be a bonus
• Electronic QMS in a medical device setting
• Line Management

ABOUT i-PHARM CONSULTING

i-Pharm Consulting is a specialist Recruitment Company servicing the global Pharmaceutical industry. 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 and Bioinformatics.

www.i-pharmconsulting.com

TO APPLY

If you would like to discuss this vacancy further, please call Business Manager, Tom Desborough on +61 (0) 2 8310 5843, or email tdesborough@i-pharmconsulting.com. If this role is not suitable, Tom is also available to discuss other possible positions or answer any general questions regarding your career and the current market.