Senior Manager, QA Site Compliance
The Opportunity:
We are looking for a Senior Manager, QA Site Compliance to provide leadership support to all compliance activities across the site including assessment of compliance with both regulatory and CSL/Seqirus requirements, KPI management, inspection readiness, and CAPA execution. You will ensure adherence to GMP/GxP standards and regulatory requirements, with a focus on compliance activities including external Health Authority Inspections. You will manage site self-inspection programs, coordinating quality management reviews, and escalating compliance issues.
You will perform gap assessments for other audits at sites within the CSL network according to procedure. You will be responsible in the evaluation of the site against the output of external regulatory or internal CSL audits, changes of market specific regulations, and the coordination and delivery of site-based gap assessments according to appropriate timelines. This will involve appropriate liaison with the global Compliance and Risk groups.
Key Responsibilities:
Reporting to the Senior Director, Global Quality Assurance, you will:
- Lead audit readiness activities, including TGA, DAFF, OGTR and FDA inspections, and act as the primary contact for regulatory and corporate audits.
- Execute the site self-inspection program to verify compliance with global GMP regulations including the completion of any Animal Ethics audits as per the scheduled requirements.
- Manage site-based deliverables for local and global quality management reviews.
- Perform gap assessments and ensure timely closure of actions from audits.
- Maintain processes, procedures, and SOPs for handling inspections.
- Foster a culture of continuous improvement and audit readiness within the site teams.
- Oversee CAPA execution and ensure timely resolution of compliance issues.
- Escalate compliance issues to ensure prompt resolution.
Skills & Experience:
- Bachelor's degree in science or engineering; advanced degree.
- 5-10 years' experience engineering, manufacturing, or quality management in regulated industry
- Strong knowledge of GMP, quality, and risk management.
- Excellent leadership, organizational, and communication skills.
- Proven experience in managing regulatory inspections and audits.
- Experience with manufacturing processes and compliance requirements.
How to Apply?
Please submit your application with your resume by 14th February 2025.
#LI-Onsite
Our Benefits
CSL 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 CSL Seqirus.
About CSL Seqirus
CSL Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. In Australia, CSL Seqirus is also a leading provider of speciality pharmaceuticals and other essential vaccines. Learn more about CSL Seqirus.
We want CSL Seqirus to reflect the world around us
As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL Seqirus.
Do work that matters at CSL Seqirus!
The Opportunity:
We are looking for a Senior Manager, QA Site Compliance to provide leadership support to all compliance activities across the site including assessment of compliance with both regulatory and CSL/Seqirus requirements, KPI management, inspection readiness, and CAPA execution. You will ensure adherence to GMP/GxP standards and regulatory requirements, with a focus on compliance activities including external Health Authority Inspections. You will manage site self-inspection programs, coordinating quality management reviews, and escalating compliance issues.
You will perform gap assessments for other audits at sites within the CSL network according to procedure. You will be responsible in the evaluation of the site against the output of external regulatory or internal CSL audits, changes of market specific regulations, and the coordination and delivery of site-based gap assessments according to appropriate timelines. This will involve appropriate liaison with the global Compliance and Risk groups.
Key Responsibilities:
Reporting to the Senior Director, Global Quality Assurance, you will:
- Lead audit readiness activities, including TGA, DAFF, OGTR and FDA inspections, and act as the primary contact for regulatory and corporate audits.
- Execute the site self-inspection program to verify compliance with global GMP regulations including the completion of any Animal Ethics audits as per the scheduled requirements.
- Manage site-based deliverables for local and global quality management reviews.
- Perform gap assessments and ensure timely closure of actions from audits.
- Maintain processes, procedures, and SOPs for handling inspections.
- Foster a culture of continuous improvement and audit readiness within the site teams.
- Oversee CAPA execution and ensure timely resolution of compliance issues.
- Escalate compliance issues to ensure prompt resolution.
Skills & Experience:
- Bachelor's degree in science or engineering; advanced degree.
- 5-10 years' experience engineering, manufacturing, or quality management in regulated industry
- Strong knowledge of GMP, quality, and risk management.
- Excellent leadership, organizational, and communication skills.
- Proven experience in managing regulatory inspections and audits.
- Experience with manufacturing processes and compliance requirements.
How to Apply?
Please submit your application with your resume by 14th February 2025.
#LI-Onsite
Our Benefits
CSL 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 CSL Seqirus.
About CSL Seqirus
CSL Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. In Australia, CSL Seqirus is also a leading provider of speciality pharmaceuticals and other essential vaccines. Learn more about CSL Seqirus.
We want CSL Seqirus to reflect the world around us
As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL Seqirus.
Do work that matters at CSL Seqirus!
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