Csl - Australia | Director Audit, Inspection & Performance Optimisation | Melbourne (City)
vor 1 Monat
Your Role
The Director Audit, Inspection & Performance Optimisation is responsible for creating and maintaining CSL's strategic framework for the lifecycle management and oversight of pharmacovigilance audits, inspections, and related process performance improvements.
Reporting to the Head of International Pharmacovigilance, this position leads in formulating the strategy, related procedures, guidelines, best practices, and tools that support Safety Officers (SO) globally.
You will ensure Pharmacovigilance (PV) audit/inspection readiness and management methods are implemented by identifying and implementing process optimisation initiatives.
Your Responsibilities
Coordinate the implementation of inspection and audit readiness activities within Regions/Affiliates Support all global Quality forums to communicate the health of the Regions PV sub-system (e.g., PVSQC and Commercial Quality Council) Work with Regions Representatives and SOs as applicable to manage out-of-compliance activities/metrics and support the implementation of process improvement initiatives Support the PV audit process for affiliates/vendors across the globe Review/provide input to the Annual Audit Plan in close collaboration with Regional Heads & Safety Officers Oversee audit preparation activities, front and back-room support during audits, provide guidance/advice for audit responses to ensure consistency and alignment with local and global requirements Ensure issues or non-compliances identified during audit/inspection readiness are managed and escalated in accordance with CSL deviation and issue escalation process Implement proactive PV change management activities for Regions and Affiliates to support audit/inspection readiness, ensuring Regions/Affiliate appropriate change planning Ensure Regions/Affiliate/vendor CAPA generated from audits and inspections are followed up and closed in a timely manner in close collaboration with auditee and auditor Drive the uptake of a Regions/Affiliate audit/Inspection ready mindset, mentoring and coaching personnel to implement audit/Inspection readiness activities Monitor industry trends, best practices, and experiences applicable to GCSP Regions and SOs, related to PV audits, inspections and process optimisation
Your Experience
Degree (Bachelor/Masters/Diploma) in a Business related or scientific/medical/pharmaceutical discipline 10+ years' experience in the biotech/pharma industry is preferable Minimum 5 years' experience with pharmacovigilance audits and inspections, of directly working in PV Quality and/or PV compliance function Knowledge of the activities related to the Affiliate PV sector Experience in working in or with QA function Ability to develop innovative, value-add solutions to problems and issues of a complex nature
To apply, submit your CV no later than Monday 9th December
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 specialty 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
Watch our 'On the Front Line' video to learn more about CSL Seqirus #J-18808-Ljbffr
-
Director Audit, Inspection
vor 1 Monat
Melbourne, Österreich Csl - Australia VollzeitYour RoleThe Director Audit, Inspection & Performance Optimisation is responsible for creating and maintaining CSL's strategic framework for the lifecycle management and oversight of pharmacovigilance audits, inspections, and related process performance improvements.Reporting to the Head of International Pharmacovigilance, this position leads in formulating...
-
Director Audit, Inspection
vor 1 Monat
Melbourne, Österreich Csl - Australia VollzeitYour RoleThe Director Audit, Inspection & Performance Optimisation is responsible for creating and maintaining CSL's strategic framework for the lifecycle management and oversight of pharmacovigilance audits, inspections, and related process performance improvements.Reporting to the Head of International Pharmacovigilance, this position leads in formulating...
-
Director Audit, Inspection
vor 1 Monat
Melbourne, Österreich Csl - Australia VollzeitYour RoleThe Director Audit, Inspection & Performance Optimisation is responsible for creating and maintaining CSL's strategic framework for the lifecycle management and oversight of pharmacovigilance audits, inspections, and related process performance improvements.Reporting to the Head of International Pharmacovigilance, this position leads in formulating...
-
Director Audit, Inspection
vor 1 Monat
Melbourne, Österreich Csl VollzeitYour Role The Director Audit, Inspection & Performance Optimisation is responsible for creating and maintaining CSLs strategic framework for the lifecycle management and oversight of pharmacovigilance audits, inspections, and related process performance improvements. Reporting to the Head of International Pharmacovigilance, this position leads in formulating...
-
Director Audit, Inspection
vor 1 Monat
Melbourne, Österreich This Is An It Support Group VollzeitYour RoleThe Director Audit, Inspection & Performance Optimisation is responsible for creating and maintaining CSL's strategic framework for the lifecycle management and oversight of pharmacovigilance audits, inspections, and related process performance improvements.Reporting to the Head of International Pharmacovigilance, this position leads in formulating...
-
Melbourne, Österreich Tideri Jobbörse VollzeitYour Role The Director Audit, Inspection & Performance Optimisation is responsible for creating and maintaining CSL's strategic framework for the lifecycle management and oversight of pharmacovigilance audits, inspections, and related process performance improvements.Reporting to the Head of International Pharmacovigilance, this position leads in formulating...
-
Melbourne, Österreich Tideri Jobbörse VollzeitSummary of RoleReporting to the Senior Director, Global Business Development and Licensing, this role is responsible, on a global basis, for business development and licensing activities for the CSL product portfolio.This includes leading cross-functional, global and regional diligence and deal teams, and negotiating licence and distribution agreements...
-
Melbourne, Österreich Tideri Jobbörse VollzeitYour RoleCSL are hiring a Scientist, Analytical Antibodies to join our team in Melbourne.Our CSL Melbourne Global Head Quarters is a unique mix of A Grade offices, meeting rooms and laboratories over 23 levels located in the Melbourne Bio-Medical Precinct.You will deliver assays and analytical reagents supporting Seqirus' SARS-CoV-2 and influenza vaccine...
-
Melbourne, Österreich Tideri Jobbörse VollzeitAs the Director, Asset Innovation Evaluation, you will be responsible for the development of commercial opportunity assessments that inform prioritization and decision-making regarding investment in internal and external asset-level innovation.This role works closely with the Global Commercial Development Therapy Area (TA) Teams, R&D, Global Insights and...
-
Director, Corporate Communications
vor 1 Monat
Melbourne, Österreich Csl - Australia VollzeitYour Opportunity:You are a seasoned and strategicDirector of Corporate Communicationspoised to join a newly remodelled global Corporate and External Affairs team based at our new, award winning, Corporate headquarters in Melbourne.In this key leadership role, you will shape and execute CSL's corporate communications strategy, building a compelling story,...
-
Qms Process Optimisation Lead
vor 2 Monaten
Melbourne, Österreich Csl - Australia VollzeitThe Opportunity: We are looking for a dynamic and experienced QMS Process Optimization Lead to join our Quality Management Systems (QMS) team.You will help enhance our Quality Management Systems, ensuring they are efficient, effective, and aligned with our global standards.As a regional Lead, you will utilize Lean and agile methodologies to optimize Quality...
-
Director, Corporate Communications
vor 1 Monat
Melbourne, Österreich Csl - Australia VollzeitYour Opportunity:You are a seasoned and strategic Director of Corporate Communications poised to join a newly remodelled global Corporate and External Affairs team based at our new, award winning, Corporate headquarters in Melbourne.In this key leadership role, you will shape and execute CSL's corporate communications strategy, building a compelling story,...
-
Director - Bioinformatics & Ai
vor 3 Wochen
Melbourne, Österreich Csl - Australia VollzeitYour RoleIn the role of Director, Bioinformatics & AI you will lead a team focused on the method development and application of computational approaches for addressing scientific questions in pre-clinical research and translational medicine; focusing on genetics, omics, imaging, biomedical literature, and RWD data modalities.As a member of the biomedical...
-
Csl - Australia | Director - Bioinformatics & Ai
vor 3 Wochen
Melbourne, Österreich Tideri Jobbörse VollzeitYour RoleIn the role of Director, Bioinformatics & AI you will lead a team focused on the method development and application of computational approaches for addressing scientific questions in pre-clinical research and translational medicine; focusing on genetics, omics, imaging, biomedical literature, and RWD data modalities.As a member of the biomedical...
-
Director - Bioinformatics & Ai
vor 3 Wochen
Melbourne, Österreich Csl - Australia VollzeitYour RoleIn the role of Director, Bioinformatics & AI you will lead a team focused on the method development and application of computational approaches for addressing scientific questions in pre-clinical research and translational medicine; focusing on genetics, omics, imaging, biomedical literature, and RWD data modalities.As a member of the biomedical...
-
Engagement Engineer- Building Operations
vor 3 Wochen
Melbourne, Österreich Csl VollzeitThe Opportunity: We are looking for a dynamic and dedicated Engagement Engineer to become a key player in our Building, Operations, and Services (BOS) team at CSL Melbourne.This permanent role offers an exciting opportunity to contribute to the coordination, development, and operational support of our Engineering Services, with a special focus on building...
-
Melbourne, Österreich Tideri Jobbörse VollzeitAdd expected salary to your profile for insights.You are a seasoned and strategic Director of Corporate Communications poised to join a newly remodelled global Corporate and External Affairs team based at our new, award winning, Corporate headquarters in Melbourne.In this key leadership role, you will shape and execute CSL's corporate communications...
-
Director, Marketing Primary Immunodeficiency
vor 2 Monaten
Melbourne, Österreich Csl - Australia VollzeitPurpose: The Director for Immunoglobulins (IG) Portfolio, Primary Immunodeficiency (PID), develops and implements brand and disease area strategy for the CSL Behring international (INT) region.You will be the vanguard of improving sales growth through a combination of market expansion and brand adoption strategies that align across a diverse international...
-
Director - Bioinformatics & Ai
vor 3 Wochen
Melbourne, Österreich Csl - Australia VollzeitYour RoleIn the role of Director, Bioinformatics & AI you will lead a team focused on the method development and application of computational approaches for addressing scientific questions in pre-clinical research and translational medicine; focusing on genetics, omics, imaging, biomedical literature, and RWD data modalities. As a member of the biomedical...
-
Scientist, Analytical Antibodies
vor 1 Monat
Melbourne, Österreich Csl VollzeitYour RoleCSL are hiring a Scientist, Analytical Antibodies to join our team in Melbourne. Our CSL Melbourne Global Head Quarters is a unique mix of A Grade offices, meeting rooms and laboratories over 23 levels located in the Melbourne Bio-Medical Precinct.You will deliver assays and analytical reagents supporting Seqirus' SARS-CoV-2 and influenza vaccine...
