Director, Global Sterility Assurance

Job Description

Reporting to the head of Global Quality Assurance, the Director Sterility Assurance will provide microbiological oversight across all Seqirus manufacturing sites to assure that approaches to sterility assurance practices are adopted, and that daily manufacturing operation runs observing its validated status, all SOPs, the Quality manual and Good Manufacturing Practice. You will oversee sterility assurance investigations at each site ensuring a risk assessment approach is used.

Provide consultation on Sterility Assurance at each site

• Provide subject matter expertise on sterility assurance best practices and mitigation strategies
• Ensure collaboration/communications on Sterility Assurance issues across Quality Assurance, the laboratories and the manufacturing areas.
• Evaluate deviations from a sterility assurance and QA perspective to identify trends and mitigation strategies that can be implemented across sites

Assure the microbial assurance aspects of the Quality System are implemented across sites

• Implement, globally, the sterility assurance aspects of the Quality System
• Design and oversee the sterility assurance risk assessment process at each site as part of the site Quality plan.
• Present important trends and issues at the Global Quality Council.
• Maintain knowledge of changes in Regulatory authority requirements and expectations.

Maintain knowledge of new/updated regulations and trends

• Understand new/updated regulations and track trends affecting Sterility Assurance
• Ensure that staff are educated on regulatory trends and possible effects
• Educate senior leadership on regulations and trends and the impact on operations, including CMOs

Track Sterility across sites and escalate latest trends to important partners

• Identify sterility issues that present a trend across sites; escalate new trends to partners and Global departments
• Ensure each site has a process to ensure that all of operational areas are aware of results obtained and trends that are developing ensuring that they have the opportunity to contribute to root cause investigations

Provide Global Sterility Assurance team leadership

• Provide guidance to site-based Sterility Assurance teams to executive on Quality Assurance strategies and programmes.
• Set goals and provide clear direction for execution at the sites concerning sterility assurance.

Education Requirements

Graduate level in a related discipline (Microbiology, Biochemistry, Pharmaceutical Sciences)

Experience Requirements

• 6 years' experience in Sterility Assurance processes
• 3 years' experience leading a Team with some global input
• cGMP background in the Pharmaceutical industry
• Experience of Quality Control testing techniques and industry practices

About Us
Our Benefits
Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the benefits you can participate in when you join Seqirus.
About Seqirus
Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about Seqirus .
We want Seqirus to reflect the world around us
As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at Seqirus.
Do work that matters at Seqirus!