At a Glance
- Tasks: Lead vendor oversight and ensure quality compliance in R&D activities.
- Company: Join CSL Seqirus, a global leader in influenza vaccine production.
- Benefits: Enjoy competitive pay, health perks, and a supportive work culture.
- Other info: Be part of a diverse team driving innovation and inclusion.
- Why this job: Make a real impact on global health through quality assurance.
- Qualifications: 3+ years in GxP quality with strong analytical and communication skills.
The predicted salary is between 60000 - 75000 £ per year.
The Vendor/Supplier QA Auditor role will support 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: Provide input to R&D/Technical customers on 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). Maintain vendor KPIs/SLAs, quality dashboards, and governance forums for performance, risk, and remediation tracking. Prepare periodic vendor reviews (e.g., QBRs) as appropriate, ensuring KPIs achieve target level, actions, and corrective and preventive actions (CAPAs) are implemented/verified to assess 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. Support 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: Maintain risk logs and 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.
GLP/GCLP Vendor Oversight and QA Lead (EU) in Slough employer: CSL Seqirus
CSL Seqirus is an exceptional employer that prioritises inclusion and belonging, fostering a culture of curiosity and empathy. With a commitment to employee well-being, the company offers comprehensive benefits and robust opportunities for professional growth, all while being at the forefront of global health innovation in the vibrant EU market. Joining CSL means being part of a diverse team dedicated to making a meaningful impact on public health through quality assurance and vendor oversight.
StudySmarter Expert Advice🤫
We think this is how you could land GLP/GCLP Vendor Oversight and QA Lead (EU) in Slough
✨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. We all know that sometimes it’s not just what you know, but who you know that can land you that dream job.
✨Tip Number 2
Prepare for interviews by researching the company and its culture. We recommend practicing common interview questions and even role-playing with a friend. The more comfortable you are, the better you’ll perform when it counts!
✨Tip Number 3
Follow up after interviews! A quick thank-you email can go a long way in showing your enthusiasm for the role. We suggest mentioning something specific from the interview to remind them of your conversation.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, we love seeing familiar names pop up in our system!
We think you need these skills to ace GLP/GCLP Vendor Oversight and QA Lead (EU) in Slough
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the GLP/GCLP Vendor Oversight and QA Lead role. Highlight your relevant experience in vendor management, quality assurance, and compliance with GxP regulations. We want to see how your skills align with what we're looking for!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about this role and how your background makes you a perfect fit. Don’t forget to mention any specific experiences that relate to vendor oversight and quality management.
Showcase Your Communication Skills:Effective communication is key in this role, so make sure your application reflects that. Use clear, concise language and structure your documents well. We want to see that you can convey complex information simply and effectively!
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way to ensure your application gets into the right hands. Plus, you’ll find all the details you need about the role and our company culture there!
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 frameworks confidently 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 conducted audits. Use the STAR method (Situation, Task, Action, Result) to structure your responses and highlight your achievements.
✨Collaborative Mindset
This role requires working closely with various teams. Be ready to discuss how you've collaborated with cross-functional teams in the past. Highlight your communication and negotiation skills, as these will be key in ensuring smooth partnerships.
✨Continuous Improvement Focus
Demonstrate your commitment to quality by discussing how you've driven improvements in vendor processes or quality systems. Share any metrics or outcomes that illustrate your impact, as this will resonate well with the interviewers.
