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

Employer
i-Pharm Consulting
Location
New South Wales, Australia, Sydney
Salary
AUD180000 - AUD250000 per annum
Start date
15 Jan 2023
Closing date
29 Jan 2023

View more

Discipline
Quality
Hours
Full Time
Contract Type
Permanent
Experience Level
Management
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Job Details

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.

Company

i-Pharm Consulting provides Talent Solutions for the global Life Sciences sector.

We are an award-winning international life sciences recruitment company with offices in London, Munich, Frankfurt, Sydney, New York, Charlotte, and Los Angeles. In a highly competitive marketplace, we connect top talent with the very best opportunities.

Since 2008, i-Pharm’s independent, expert, and ethical approach to procuring talent has helped power the pioneering progress made by Pharmaceutical, Biotech and MedTech companies around the world. 

With offices across 3 continents, we have teams servicing the major global life science hubs. We combine local knowledge, with a global network of contacts that allows us to bring together talent and opportunity when it matters most.

For candidates, we become “career partners”. We know them as people, not CVs, learning about their aims, motivations and personal situation. We build open dialogue, provide honest advice and offer ongoing support, whether or not we’re currently working with them. ​

As a result, we have supported many specialists in this focused field throughout their careers, helping them plan their path through life sciences by identifying the right roles for them, not just any roles to suit us.

We change the lives and trajectory of our candidates' careers by offering incredible opportunities with the best clients in the sector.

 

Find Us
Website
Telephone
+44 (0) 20 3189 2299
Location
52 Bedford Row
London
England
WC1R 4LR
GB
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