At a Glance
- Tasks: Lead quality oversight of external partners in R&D and regulated activities.
- Company: Join CSL Seqirus, a global leader in influenza vaccine production.
- 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 of GxP quality experience and strong analytical skills 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 maintaining 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 CAPAs 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
- Bachelors 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 in Maidenhead employer: CSL Behring
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 in Maidenhead
✨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 help you land that dream job.
✨Tip Number 2
Prepare for interviews by researching the company and its culture. Understand their values and how they align with your own. We want you to walk into that interview feeling confident and ready to show them why you’re the perfect fit for the role!
✨Tip Number 3
Practice makes perfect! Conduct mock interviews with friends or mentors to refine your answers and get comfortable with the process. We believe that the more you practice, the more natural it will feel when it’s time for the real deal.
✨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. We recommend expressing your appreciation for the opportunity and reiterating your enthusiasm for the role.
We think you need these skills to ace GMP Vendor Oversight and QA Lead in Maidenhead
Some tips for your application 🫡
Tailor Your Application:Make sure to customise your CV and cover letter for the GMP Vendor Oversight and QA Lead role. Highlight your relevant experience in vendor oversight, quality agreements, and compliance with GxP regulations. We want to see how your skills align with what we're looking for!
Showcase Your Experience:When detailing your work history, focus on specific examples that demonstrate your expertise in managing vendor relationships and conducting audits. Use metrics where possible to show the impact of your contributions. This helps us understand the value you can bring to our team.
Be Clear and Concise:Keep your application clear and to the point. Avoid jargon unless it's relevant to the role. We appreciate straightforward communication, so make it easy for us to see why you're a great fit for the position without wading through unnecessary details.
Apply Through Our Website:We encourage you to submit your application directly through our website. This ensures that your application is processed efficiently and allows us to keep track of all candidates. Plus, it’s the best way to stay updated on your application status!
How to prepare for a job interview at CSL Behring
✨Know Your Regulations
Make sure you brush up on GxP regulations and standards like GLP, GCP, and GMP. 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 conducted audits. Highlight your problem-solving skills and how you've driven quality improvements in those situations.
✨Collaborate Like a Pro
This role requires cross-functional collaboration, so be ready to discuss how you've worked with teams like Clinical Operations or Procurement. Share examples of how you’ve embedded quality requirements into projects and contracts.
✨Ask Insightful Questions
Prepare thoughtful questions about the company's approach to vendor management and quality assurance. This not only shows your interest but also gives you insight into their processes and culture.
