This Is An It Support Group | Director Audit, Inspection
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.
#J-18808-Ljbffr
-
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...
-
Sales Director
vor 3 Wochen
Melbourne, Österreich This Is An It Support Group VollzeitSales Director - Melbourne - This is an IT support groupJob Title: Director of SalesJob Summary: We are seeking a talented Director of Sales to lead our sales team in achieving exceptional results. As a chic explorer, sophisticated innovator, and imaginative problem solver, you will be responsible for developing and implementing sales strategies.Key...
-
Sales Director
vor 3 Wochen
Melbourne, Österreich This Is An It Support Group VollzeitSales Director - Melbourne - This is an IT support groupJob Title: Director of SalesJob Summary: We are seeking a talented Director of Sales to lead our sales team in achieving exceptional results.As a chic explorer, sophisticated innovator, and imaginative problem solver, you will be responsible for developing and implementing sales strategies.Key...
-
This Is An It Support Group | Sales Director
vor 3 Wochen
Melbourne, Österreich Tideri Jobbörse VollzeitSales Director - Melbourne - This is an IT support group Job Title: Director of Sales Job Summary: We are seeking a talented Director of Sales to lead our sales team in achieving exceptional results.As a chic explorer, sophisticated innovator, and imaginative problem solver, you will be responsible for developing and implementing sales strategies.Key...
-
Manager, Audit And Surveillance
vor 4 Wochen
Melbourne, Österreich This Is An It Support Group VollzeitLocation: Melbourne | CBDJob type: Full timeOrganisation: Victorian Building AuthoritySalary: Salary not specifiedOccupation: OtherReference: VG/6715We are seeking a Manager, Audit and Surveillance who will play a key leadership role to a team of field-based inspectors to conduct inspections and audits to drive compliance that ensures the VBA meets its...
-
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...
-
Melbourne, Österreich Buscojobs VollzeitPosition InformationRef #Region : Perth, WAClassification : Site Management & SupervisionDate Posted : 02-Apr-2024Description & Requirements We're recruiting for a full-time Inspection Coordinator to join our Offshore Energy team in Perth.This role will ensure quality delivery of inspection works to ensure compliance with Company Maintenance Plans and...
-
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...
-
Performance Group Director
Vor 2 Tagen
Melbourne, Österreich This Is An It Support Group VollzeitAbout GroupM NexusGroupM Nexus is the world's leading global media performance organisation that unites GroupM's global performance Talent & Technologies.Nexus unites GroupM Practices (search, social, programmatic, ad-ops, commerce) and Solutions (ATV, ADOOG, APROG and Goat) into a single unit.The global organisation is underpinned by a new cross-channel...
-
Performance Group Director
Vor 2 Tagen
Melbourne, Österreich This Is An It Support Group VollzeitAbout GroupM Nexus GroupM Nexus is the world's leading global media performance organisation that unites GroupM's global performance Talent & Technologies.Nexus unites GroupM Practices (search, social, programmatic, ad-ops, commerce) and Solutions (ATV, ADOOG, APROG and Goat) into a single unit.The global organisation is underpinned by a new cross-channel...
-
Ehs Audit And Knowledge Management
vor 2 Wochen
Melbourne, Österreich This Is An It Support Group VollzeitResponsible for compliance oversight of Global EHS programs through establishing Global EHS standards and training, and Global EHS auditing programs to minimize EHS liability for the company and minimize risk to employees and facilities.Reports to: Senior Director, Global EHS Systems & GovernanceThis position has no direct reportsResponsibilities:Create and...
-
This Is An It Support Group | Retail
Vor 2 Tagen
Melbourne, Österreich Tideri Jobbörse VollzeitThis is a SELF EMPLOYED - Contractor Position.LOCATIONS NEEDED: Perth, Melbourne & Sydney This role is operating as a self-employed associate covering work as an Assessor as determined by client terminology for the specific work.The role is responsible for delivering Food Safety audits, with the Hospitality & Retail Delivery division.This is specific audits...
-
Melbourne, Österreich Tideri Jobbörse 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...
-
Retail & Hospitality Auditor
Vor 5 Tagen
Melbourne, Österreich This Is An It Support Group VollzeitThis is a SELF EMPLOYED - Contractor Position. LOCATIONS NEEDED: Perth, Melbourne & Sydney This role is operating as a self-employed associate covering work as an Assessor as determined by client terminology for the specific work.The role is responsible for delivering Food Safety audits, with the Hospitality & Retail Delivery division.This is specific audits...
-
Retail & Hospitality Auditor
Vor 5 Tagen
Melbourne, Österreich This Is An It Support Group VollzeitThis is a SELF EMPLOYED - Contractor Position. LOCATIONS NEEDED: Perth, Melbourne & Sydney This role is operating as a self-employed associate covering work as an Assessor as determined by client terminology for the specific work.The role is responsible for delivering Food Safety audits, with the Hospitality & Retail Delivery division.This is specific audits...
-
Retail & Hospitality Auditor
Vor 5 Tagen
Melbourne, Österreich This Is An It Support Group VollzeitThis is a SELF EMPLOYED - Contractor Position.LOCATIONS NEEDED: Perth, Melbourne & SydneyThis role is operating as a self-employed associate covering work as an Assessor as determined by client terminology for the specific work.The role is responsible for delivering Food Safety audits, with the Hospitality & Retail Delivery division.This is specific audits...
-
Nexus Wavemaker | Performance Associate Director
vor 1 Monat
Melbourne, Österreich This Is An It Support Group VollzeitPERFORMANCE ASSOCIATE DIRECTOR ABOUT GROUPM NEXUSGroupM Nexus is the world's leading global media performance organisation that unites GroupM Practices (search, social, programmatic, ad-ops, commerce) and Solutions (Finecast, Xaxis, Sightline and Goat) into a single unit. The global organisation will be underpinned by a new cross-channel performance...
-
Nexus Wavemaker | Performance Associate Director
vor 1 Monat
Melbourne, Österreich This Is An It Support Group VollzeitPERFORMANCE ASSOCIATE DIRECTORABOUT GROUPM NEXUSGroupM Nexus is the world's leading global media performance organisation that unites GroupM Practices (search, social, programmatic, ad-ops, commerce) and Solutions (Finecast, Xaxis, Sightline and Goat) into a single unit. The global organisation will be underpinned by a new cross-channel performance platform,...
