GMP Vendor Oversight and Quality Assurance Lead at CSL USA

Melbourne, Victoria, Australia -

Full Time

Start Date

Immediate

Expiry Date

12 Aug, 26

Salary

0.0

Posted On

14 May, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Vendor Oversight, Quality Assurance, GxP Auditing, Quality Agreements, CAPA Management, Risk-Based Decision Making, KPI Monitoring, Regulatory Compliance, Data Integrity, Stakeholder Management, Negotiation, Analytical Problem Solving

Industry

Biotechnology Research

Description

We are seeking a Vendor / Supplier R&D Quality Assurance professional to provide quality oversight of external partners supporting CSL’s R&D and regulated activities, including CROs, CMOs, laboratories, and technology vendors. This role is responsible for managing the end‑to‑end vendor lifecycle, ensuring third‑party services meet applicable GCP, GMP, and GVP requirements, data integrity standards, and regulatory expectations. You will partner closely with Clinical, non‑Clinical, CMC, Safety, Procurement, Legal, and IT teams to enable compliant and reliable delivery from external partners and will be based at our Elizabeth street Melbourne office. This role will require 50% of travel around APAC Key Responsibilities Lead vendor qualification, re‑qualification, and governance activities using risk‑based approaches Develop, negotiate, and maintain Quality Agreements aligned with commercial contracts Plan and support GxP audits and inspections of CROs, vendors, and service providers Review audit findings and oversee CAPA development and effectiveness checks Monitor vendor performance through KPIs, SLAs, dashboards, and periodic reviews Support deviations, change controls, complaints, and CAPAs involving third parties Maintain vendor risk assessments and drive continuous improvement initiatives Act as a key QA partner across Clinical, CMC, Safety, Procurement, Legal, and IT Maintain current knowledge of GxP regulations, data integrity, and industry trends Your Experience Bachelor’s degree in a relevant scientific discipline 3+ years’ experience in GxP Quality with direct vendor/CRO/CMO oversight or auditing Working knowledge of GLP/GCP/GMP/GVP, ICH guidelines, FDA/EMA expectations, and data integrity (ALCOA+) Experience supporting or leading audits and inspections Strong analytical, problem‑solving, and risk‑based decision‑making skills Excellent communication, influencing, and negotiation capabilities Comfortable working independently in a global, cross‑functional environment Strong organisational skills with the ability to manage multiple priorities Collaborative, pragmatic, and improvement‑focused approach 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. 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 click here. CSL Global Privacy Notice for Job Applicants and Candidates

How To Apply:

Incase you would like to apply to this job directly from the source, please click here

Responsibilities

Lead the end-to-end quality oversight and governance of external R&D partners, including CROs and CMOs, to ensure compliance with GxP requirements. Manage vendor qualifications, quality agreements, and audits while monitoring performance through KPIs and CAPAs.