GVP Vendor Oversight and QA Lead

GVP Vendor Oversight and QA Lead

Entity: CSL Behring

Job Category: Quality

Job Family: Quality Assurance

Job Type: Full Time

Location: Melbourne, Victoria, Australia

Employer Reference: R-293146

Job Description

CSL is recruiting a GVP Vendor Oversight and QA Lead to join the newly established Vendor and Supplier Quality Assurance (VSQA) function within R&D Quality. This role owns the quality oversight of CSL's pharmacovigilance (PV) vendors and service providers, including safety and PV CROs, ICSR and case processing providers, literature monitoring, signal management support, medical information and call centre providers. You will lead the end-to-end PV vendor lifecycle: defining the qualification and risk-based oversight strategy, owning quality agreements, overseeing CAPAs and effectiveness checks, and driving issue management and continuous improvement.

Reporting to the Head, VSQA, you will be the senior quality point of contact for PV vendor matters within R&D Quality, partnering with and influencing Pharmacovigilance and Safety, the QPPV Office, Regulatory Affairs, QA, Procurement, Legal and senior management.

This role will be based at our Melbourne office in a hybrid capacity.

This role requires travel of up to 50% across the APAC region.

Your Responsibilities

As the GVP Vendor Oversight and QA Lead, you will:

• Vendor Lifecycle and Governance
• Define and own the risk-based qualification and requalification strategy for PV vendors.
• Lead vendor qualification activity across paper, remote and onsite assessments.
• Own the drafting, negotiation and maintenance of Quality Agreements with PV vendors.
• Establish vendor KPIs, SLAs, dashboards and governance forums, and set performance and escalation thresholds for risk and remediation.
• Lead periodic vendor reviews, holding vendors accountable to target performance and ensuring CAPAs are implemented, verified and effective.
• Quality Standards and Compliance
• Set the quality standards expected of PV vendors against EU GVP Modules, EU pharmacovigilance legislation, ICH guidelines and ALCOA+ principles.
• Own and develop the QMS procedures, templates and training that govern PV vendor oversight.
• Provide quality input to deviation, complaint, change control and CAPA processes involving PV vendors, and participate in root cause analysis where vendor performance is implicated.
• Act as the internal reference point for PV vendor quality matters, maintaining expert knowledge of GVP requirements and industry trends.
• Risk Management
• Lead risk assessments for PV vendors using FMEA and risk register approaches, setting controls and monitoring frequency based on risk.
• Analyse trends across audit findings, deviations and complaints.
• Present actionable insight at management reviews and governance forums.
• Audit Findings, CAPA Oversight and Inspections
• Review findings classifications from audits conducted by CSL's Auditing Services function, assess CAPA adequacy with vendors and own follow-up effectiveness checks. This role does not conduct audits.
• Lead PV inspection readiness for vendor-related scope.
• Provide front and back-room support during health authority inspections where PV vendor services are in scope, including inspection storyboards and support to the QPPV Office on vendor-related PSMF commitments.
• Cross-Functional Partnership and Due Diligence
• Embed quality requirements into PV vendor scopes of work and contracts, working with Procurement and Legal.
• Provide quality guidance on data flows, safety data handovers and transitions between CSL and PV vendors.
• Train internal stakeholders on PV vendor quality expectations and good practice.
• Contribute to due diligence assessments for acquisitions and divestitures involving PV vendor relationships, including quality risk identification and post-deal integration planning.

About You

• To be successful in this role, you will bring:
• Bachelor's degree in a relevant scientific discipline; a postgraduate qualification is desirable.
• Demonstrated GVP or PV quality experience, including direct oversight of vendors or service providers.
• A track record of owning quality agreements and contributing to or leading vendor oversight programmes.
• Working knowledge of audit and inspection management, with the ability to assess findings and CAPA adequacy.
• Demonstrated knowledge of EU GVP Modules, EU pharmacovigilance legislation, ICH guidance and ALCOA+ data integrity principles.
• Strong communication, influencing and negotiation skills at stakeholder and vendor level.
• The ability to work autonomously and across multinational teams.
• Willingness to travel up to 50%.

Why Join CSL?

• VSQA is a newly established function within R&D Quality, responsible for the quality oversight of external partners across GxP disciplines. Joining at this stage, you will work closely with the Head, VSQA to put the operating model in place, with genuine scope to shape how PV vendor oversight is established within the function.
• In your first months, you will map the current PV vendor base and address immediate oversight gaps, review and update Quality Agreements, set up the KPI and SLA framework for PV vendor governance, and establish working interfaces with Auditing Services and the QPPV Office.

About CSL Behring

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

Our Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.

You Belong at CSL

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

Equal Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.

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