You will have the responsibility for steering the entire development of the facility’s Quality Assurance IT strategy, ensuring the processes conform to our policies and comply with cGMPs, Health Agency regulations and all other applicable governing regulations.
You will have close collaboration with high performance talent from our global team and the biotechnology industry to develop and execute multiple Quality Assurance systems and processes.
We would like this person to have the ability to inspire his/her team to build the future of our biologics through a Quality culture that delivers unconstrained supply, that is Right First Time to patients worldwide.
A key function of this role will be providing training and guidance on the interpretation and implementation of our policies and regulatory requirements. We would like this person to have a focus on automation, commissioning, and/or quality system build.
You will have responsibility for the quality aspects of GMP computerized systems and the supporting infrastructure used in site facilities, utilities, manufacturing, packaging, labelling, and laboratories to ensure compliance with company policies, procedures and regulatory expectations.
You will get the opportunity to work closely with stakeholders and SMEs from site operations, quality operations, IT, automation and engineering.
You will report to the Quality Assurance lead Director
Qualifications / Experience
- 5+ years experiencer in Quality Control, Quality Assurance or Pharmaceutical or Technical Operations.
- A self starter and results focused, the successful candidate will have strong contemporary knowledge of relevant cGMPs, regulations and current industry trends.
- Experience in delivering validated IT solutions or an application support position in a regulated environment.
- The motivation to eb an inspiring member of a high performing team.
- The desire to continuously learn, improve and develop.
Bachelor’s degree (or higher) in Chemistry, Biology, Microbiology, Automation, Engineering or in a relevant discipline, the successful candidate will also ideally have a proven track record in delivering excellence. The candidate will also show ambition and drive to develop and advance their career
For a confidential discussion and more information on this opportunity please contact Gillian Nicholson directly on 0906478104 or email me directly at firstname.lastname@example.org