Proclinical Staffing

Quality Manager

Sydney (Region), New South Wales (AU)
$120,000-$130,000 + benefits
05 Feb 2021
07 Mar 2021
Full Time
Contract Type
Experience Level

ProClinical are working exclusively with a pharmaceutical manufacturing company based in Macquarie Park, who are looking for a Quality Manager with solid FDA experience and a pharma background, and exceptional interpersonal & management skills who can buy into the company philosophy and culture.

Role Overview:

Reporting directly to the Quality Director, this position is to develop business practices, and drive improvements, to align with the company’s global quality strategies.

Job Duties:

  • Management of direct reports and activities with internal and external stakeholders and recruitment.
  • Strategy for quality consistent with company policy, regulations and QMS management
  • Ensure product quality in all aspects
  • Manage deviations, CAPAs, Laboratory OOS investigations, internal and external audits
  • Working with the EMA and FDA and understanding of elements of regulatory affairs
  • Ensure business processes and products continuously meet the regulatory requirements of the TGA

Applicant Requirements:

  • 5 years experience in Quality or similar, working with QMS and regulatory understanding;
  • Minimum 3 years working in a management role but still with a passion for embracing the foundational work initially;
  • Relevant Tertiary education (Chemistry – at a bachelor level as a minimum. Relevant post graduate education preferred);
  • Good working knowledge of TGA and FDA, and Australian regulations.
  • Excellent communication and interpersonal skills
  • Working knowledge of GLP, GMP and Quality functions, CAPAs, deviations, validation etc.
  • Australian Resident

If interested, please call me ASAP on 0290 547 418 or email for more information.

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