GLP Vendor Oversight and Quality Assurance Lead
About this opportunity
The Opportunity:
Own quality oversight of external partners supporting nonclinical and GLP activities (CROs, laboratories, test facilities).
Lead the vendor lifecycle: due diligence, qualification, quality agreements, risk-based monitoring, issue management and continuous improvement, ensuring adherence to GLP/GCP/GMP, data integrity and applicable regulations. Partner with Nonclinical Development, Procurement, Legal and IT.
The Role:
Vendor Lifecycle and Governance: Run risk-based qualification and requalification, draft and maintain Quality Agreements, and set vendor KPIs and governance forums, ensuring actions and CAPAs are closed.
Inspections : Identify and prioritise vendors for audit on a risk basis; planning, conducting and grading sits with the audit function. Confirm vendor CAPAs are fit for purpose and run effectiveness checks. Coordinate inspection readiness and front- and back-room support.
Quality Systems and Compliance: Ensure vendor practices meet GLP/GCP/GMP, OECD GLP, 21 CFR Part 58, ICH, ISO and data integrity (ALCOA+). Provide input on third-party deviations, change control, CAPA, and the QMS.
Risk Management and Continuous Improvement: Lead vendor risk assessments (risk registers, FMEA) to set oversight frequency, improve vendor performance, and present trends at management reviews.
Cross-Functional Partnership : Embed quality requirements in scopes of work and contracts, guide technology transfers and data flows, and train internal stakeholders.
Maintain and share knowledge of Regulations and Requirements: Stay current with GLP and GxP regulations and translate changes into CSL requirements.
Skills & Experience:
Bachelor's degree in a relevant scientific discipline.
3+ years of GxP quality experience with direct vendor/CRO oversight and/or auditing (GLP/GCP/GMP), nonclinical/GLP preferred.
Knowledge of OECD GLP, 21 CFR Part 58, Annex 11/Part 11 and data integrity (ALCOA+).
Competencies: Works with limited supervision across multinational teams. Strong analytical, problem-solving, influencing and organisational skills. Knowledge of QMS implementation, regulatory frameworks and audit/inspection management.
Competencies
Ability to work with limited supervision and with multinational teams and external suppliers speaking different languages.
Strong analytical and demonstrated problem solving skills, excellent interpersonal/communication/influencing/negotiation skills, and excellent organizational skills with respect to planning / tracking and timelines.
Demonstrated knowledge of QMS implementation and regulatory frameworks.
A strong understanding of the requirements for Quality Assurance in relevant GxP discipline.
Experience in audit/inspection management and processes.
Travel: This role will include up to 50% travel
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 .
Job details
How this role compares
Computed from every other active Quality role in our database, not just this employer's listings.
We currently track 757 comparable Quality roles across 94 biopharma companies.
Salary context
145 of 757 peers report a salary range (USD, annualized)
Peers share this role's job function. This posting doesn't list a seniority level, so peers aren't narrowed by seniority either -- the range below may span more levels than usual.
Where these roles are based
Top locations among the 757 comparable roles
+ 42 more countries
Seniority mix
350 of 757 peers have a known seniority level
Therapeutic area mix
1 of 757 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
Similar opportunities
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How we calculate "similar"
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Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.