At a Glance
- Tasks: Oversee quality of external partners in R&D and regulated activities.
- Company: Join CSL Seqirus, a leading global influenza vaccine provider.
- Benefits: Enjoy competitive salary, health benefits, and a supportive work culture.
- Other info: Collaborative environment with opportunities for professional growth.
- Why this job: Make a real impact on global health through quality assurance.
- Qualifications: 3+ years in GxP quality with vendor oversight experience required.
The predicted salary is between 60000 - 80000 £ per year.
The Vendor/Supplier QA Auditor role will own the quality oversight of external partners supporting R&D and regulated activities (e.g., CROs, CMOs, laboratories, technology vendors). Lead the end-to-end vendor lifecycle—due diligence, qualification, quality agreements, risk based monitoring, issue management, and continuous improvement—ensuring adherence to GLP/GCP/GMP/GVP, data integrity and applicable regulations. This role partners closely with Clinical, Nonclinical, CMC, Safety, Procurement, Legal, and IT to enable compliant, reliable delivery from third parties.
Main Responsibilities and Accountabilities:
- Vendor Lifecycle & Governance
- Define and execute risk-based vendor qualification and requalification strategies (paper assessments, remote/onsite diligence assessments, performance reviews).
- In collaboration with R&D/Technical/Legal and QA Functional teams contribute to drafting, negotiating, and maintain Quality Agreements aligned to master service agreements (roles/responsibilities, quality standards, change control, deviation management, data integrity, and inspection support).
- Establish and assure upkeep of vendor KPIs/SLAs, quality dashboards, and governance forums for performance, risk, and remediation tracking.
- Lead periodic vendor reviews (e.g., QBRs) as appropriate, ensuring KPIs achieve target level, actions, and corrective and preventive actions (CAPAs) are implemented/verified to assure the overall health of the relationship.
- Inspections
- Support planning of routine GxP audits of CROs, CMOs, labs, and system/service providers; ensuring findings are classified, graded, and reported internally and externally.
- Liaise with Vendors/Suppliers to assure corrective and preventative CAPA’s are defined and fit-for-purpose. Perform follow up effectiveness checks.
- Coordinate inspection readiness and provide front/backroom support when third party services are in scope, support development of storyboards.
- Maintain auditee scheduling, auditor qualification, and audit program metrics.
- Quality Systems & Compliance
- Ensure vendor practices meet GLP/GCP/GMP/GVP, ICH, OECD, ISO, and data integrity principles (ALCOA+) as well as other function specific guidelines, regulations, standards.
- Provide input to deviation, complaint, change control, and CAPA processes involving third parties; participate in root cause analysis where appropriate.
- Contribute to the Quality Management System (QMS)—procedures, templates, and training—for third party oversight.
- Risk Management & Continuous Improvement
- Lead risk assessments (e.g., risk registers, FMEA) to prioritize controls and monitoring frequency for specific vendors/suppliers.
- Drive quality improvements with vendors (process robustness, right first time (cycle time reduction, etc.).
- Analyze trends (audit findings, deviations, complaints) and present management reviews with actionable insights.
- Cross Functional Partnership
- Collaborate with Clinical Operations, Nonclinical, CMC, Safety, Supply Chain, Procurement, Legal, and IT to embed quality requirements in scopes of work and contracts.
- Provide guidance during technology transfers, method validations, sample handling, and data flows between sponsor and vendors.
- Act as CSL Person-in-Plant as appropriate to provide contemporaneous quality support to CSL specific vendor operations.
- Train internal stakeholders on third party quality expectations and best practices.
- Maintain and share knowledge of Regulations and Requirements
- Stay current and up to date with GxP regulations and requirements related to audit management as well as industry/regulatory trends in this area.
- Identify and/or create new requirements to ensure a high level of quality and communicate internally.
Position Qualifications and Experience Requirements:
- Education
- Bachelor’s degree in relevant scientific discipline.
- Experience
- 3+ years of GxP quality experience with direct vendor/CRO/CMO oversight and/or auditing (GLP/GCP/GMP).
- Demonstrated knowledge of one or more of the following ICH (e.g., E6(R2)/E8(R1)/Q9(R1)), OECD GLP, FDA, EMA, EU Annex 11/21 CFR Part 11, and data integrity (ALCOA+).
- Effective communication and negotiation skills.
- 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.
GMP Vendor Oversight and QA Lead employer: CSL Seqirus
CSL Seqirus is an exceptional employer that prioritises employee well-being and professional growth, offering a collaborative work culture where innovation thrives. With a strong commitment to inclusion and belonging, employees are empowered to contribute meaningfully to global health initiatives while enjoying comprehensive benefits and opportunities for continuous improvement in their careers. Located in a state-of-the-art facility, the company fosters a dynamic environment that supports both personal and professional development.
StudySmarter Expert Advice🤫
We think this is how you could land GMP Vendor Oversight and QA Lead
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, attend relevant events, and don’t be shy about asking for introductions. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by researching the company and its culture. Understand their values and how they align with your own. This will help you tailor your responses and show that you're genuinely interested in being part of their team.
✨Tip Number 3
Practice makes perfect! Conduct mock interviews with friends or use online platforms to get comfortable with common questions. The more you practice, the more confident you'll feel when it’s time to shine in front of the real interviewers.
✨Tip Number 4
Don’t forget to follow up after your interviews! A simple thank-you email can go a long way in leaving a positive impression. It shows your enthusiasm for the role and keeps you fresh in their minds as they make their decision.
We think you need these skills to ace GMP Vendor Oversight and QA Lead
Some tips for your application 🫡
Tailor Your Application:Make sure to customise your CV and cover letter to highlight your experience in vendor oversight and quality assurance. We want to see how your skills align with the specific requirements of the GMP Vendor Oversight and QA Lead role.
Showcase Relevant Experience:When detailing your work history, focus on your GxP quality experience and any direct involvement with vendors or CROs. We love seeing concrete examples of how you've managed quality agreements or conducted audits.
Be Clear and Concise:Keep your application straightforward and to the point. Use bullet points where possible to make it easy for us to read through your qualifications and achievements quickly.
Apply Through Our Website:We encourage you to submit your application directly through our website. This ensures that your application gets to the right people and helps us keep track of all candidates efficiently.
How to prepare for a job interview at CSL Seqirus
✨Know Your Regulations
Make sure you brush up on GLP, GCP, GMP, and GVP regulations before the interview. Being able to discuss these in detail will show that you understand the compliance landscape and can navigate it effectively.
✨Showcase Your Experience
Prepare specific examples from your past roles where you've successfully managed vendor oversight or quality assurance. Highlight any risk assessments or CAPA processes you've led, as this will demonstrate your hands-on experience in the field.
✨Collaborative Mindset
Since this role involves working closely with various departments, be ready to discuss how you've collaborated with teams like Clinical, Legal, or IT in the past. Share examples of how you’ve embedded quality requirements into projects to ensure compliance.
✨Ask Insightful Questions
Prepare thoughtful questions about the company's vendor management strategies and how they measure success. This shows your genuine interest in the role and helps you assess if the company’s values align with yours.
