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Job details

Location
Sydney
Salary
Negotiable
Job Type
Full Time
Ref
38277
Contact
Madeleine Byrnes
Posted
10 days ago

Job details

Location
Sydney
Salary
Negotiable
Job Type
Full Time
Ref
38277
Contact
Madeleine Byrnes
Posted
10 days ago

Benefits

An opportunity to utilise your diverse experience in Clinical Research or Medical affairs at a market leading global pharmaceutical company has become available. The company is committed to investing in their employee's well-being and growth. There will be development opportunities, an attractive salary package with extra leave entitlements, additional super contribution matching and very flexible working arrangements.

About the company

A company motivated to make life better for people around the world through discovery. With over 140 years' experience and almost 100 medicines available, the company continues to strive for excellence, integrity, and respect. The company also endeavours to improve the understanding and management of diseases and is proud of their philanthropic focus.

About the opportunity

A Sydney based GxP Quality Manager role has become available at a renowned global pharmaceutical company. The company is based in Northwest Sydney with the option to WFH most days if preferred. You will be overseeing the implementation of quality system initiatives, keeping abreast of GxP trends to advise the company both locally and globally.

Duties

  • Ensure the implementation of the Safety and Efficacy Quality System (SEQS). This will involve reviewing of local and international SOPs as well as providing insight and implementing initiatives regarding compliance concerns across the company
  • Approve and provide insight on company tools, templates, and procedures from a quality compliance perspective
  • Maintain 'audit ready' environment by conducting quality assessments and facilitating inspections
  • Interpret relevant guidelines and regulations and implement protocols to ensure compliance both locally and globally
  • Be the main point of contact for global and ANZ compliance concerns
  • Ensure the implementation of regional and global Quality Plans, providing reports to internal and external stakeholders on their progress
  • Consult and support the business with quality systems including deviations, change controls, CAPAS and root cause analysis processes
  • Analyse trends of quality systems using key metrics, provide insight into strengths, weaknesses and advise on strategies that can be implemented to address findings
  • Continue to coordinate and drive the improvement, efficiency, and simplification of procedures from a Quality perspective

Skills and Experience

  • Tertiary qualification in Pharmacy, Chemistry (Pharmaceuticals), Science or related field
  • Experience implementing and analysing Quality systems within a highly regulated environment
  • Experience in Pharmacovigilance, Regulatory Affairs, Medical Affairs or Clinical Research
  • Excellent communication skills
  • Experience in applying risk-based decision making within a regulated environment

Culture

Collaborative team environment. Company values integrity, discovery, and respect.

How to Apply

Click apply or contact Madeleine Byrnes, Sourcing Consultant on 0288778703 for a confidential discussion.

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