- 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.
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.
- 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
- 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 email@example.com for more information.
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