Experience

Extractas Bioscience

• Australia
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Compliance Director

  • Jan 2019 - Present

  My role of Compliance Director brings Quality Regulatory Affairs, IT and EHS under a single management model that is responsible for ensuring that the business can achieve its legal obligations across these areas.

• Director Business Development

  • Sep 2016 - Dec 2018

  Lead the development and execution of the TasAlk growth strategy by contacting and developing relationships with key industry participants. The position was responsible for identifying new products and markets assessing, the potential revenue and costs of good and competitor analysis. The position provided strategic knowledge to formulating and/or updating the strategic plan and executing actions associated with growing the business.

• Director Quality Operations

  • Jan 2014 - Sep 2016

  • Manage Quality Release, Quality Compliance and Quality Laboratory Supervisors as well as other applicable personnel. • Acts as a quality consultant to site personnel and Tasmanian Alkaloids Executive Leadership Team on complex GMP issues that require a unique interpretation of GMP and FDA guidelines. • Makes go/no decisions regarding product release when exceptional issues arise. Review results of multidisciplinary team investigations held to resolve complex product issues or GMP manufacturing system failures and ensure Quality Operations group and/or customers implement the necessary system improvements. • Leads all Quality audits and interactions with appropriate regulatory bodies, guiding the site QA personnel and Tasmanian Alkaloids managers

• Production Manager

  • Jan 2003 - Dec 2013

  I joined the production team in 2003 as a Technical Officer for the extraction plant and then moved to the Assistant Production Manager in 2004. In these roles I developed extensive knowledge of the plant and the processes for the extraction of different poppy varieties. I have experience in compliance requirements for quality, safety and environment for the production of narcotic raw materials. I achieved a talent for leading and establishing a team environment. In 2008 I was promoted to the position of Production Manager which increased my responsibilities to include the Chemical and Specialty Chemical Plants. These two facilities produced APIs which further enhanced my knowledge of quality (GMP) compliance.

• Quality Laboratory Analyst & Supervisor

  • Apr 1998 - Jan 2003

• R&D Technician

  • Apr 1997 - Apr 1998