Senior Pharmaceutical Compliance Manager

4 days ago

Melbourne, Victoria, Australia beBeeQuality Full time $90,000 - $150,000

**Pharmaceutical Quality Assurance Manager Role**

About the Opportunity:

We are seeking a highly skilled Pharmaceutical Quality Assurance Manager to join our team. The successful candidate will be responsible for ensuring the quality of systems and processes, reviewing and approving related records, supporting quality risk assessments, non-conformances, investigations, CAPAs, and change controls.

The Role:

  • Manage and oversee all aseptic filling and support related activities to provide real-time review of process steps, media filling; and visual inspection oversight, documentation, activities and behavior;
  • Support product quality and compliance partnering with all teams regarding quality aspects;
  • Manage and approve deviation processes, including initial risk assessment meetings, creation of environmental / personnel trends, root cause analysis, development and agreement of CAPAs and analysis of repeat issues;
  • Perform QA review and approval of operational, processing and records to ensure regulatory compliance with Australian, EMEA and USA regulatory requirements;
  • Participate in batch document review and manage change controls to ensure that planned implementation actions are appropriate and supported by relevant level of risk statements;
  • Lead and influence continuous improvement activities including global harmonisation projects and 'Right First Time' projects.

Required Skills and Qualifications:

  • A degree in science or engineering or pharmaceutical science;
  • 5+ years' experience in a similar role in pharmaceutical manufacturing, quality compliance;
  • 3+ years' experience with the aseptic filling;
  • Experience with cGxP regulatory requirements including risk-based decisions, inspections and industry guidance documents such as those required by TGA or FDA;
  • Experience leading a technical team in a regulated environment and providing technical support;
  • Experience preparing written technical documents and presenting complex information;
  • Experience in a role requiring conceptual and analytical thinking to reconcile ambiguities;
  • Flexibility to support out of hours media fills or other quality escalations.

Benefits:

We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.

About Us:

We are a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas.

Join Our Team:

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