At a Glance
- Tasks: Oversee quality of external partners in R&D and regulated activities.
- Company: Join a leading biopharmaceutical company committed to innovation and quality.
- Benefits: Competitive salary, health benefits, and opportunities for professional growth.
- Other info: Collaborative environment with diverse teams and global reach.
- Why this job: Make a real impact on quality assurance in life-saving research.
- Qualifications: Bachelor’s degree and 3+ years of GxP quality 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.
Responsibilities
- 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 levels, 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). 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.
- Regulatory Knowledge: 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.
Qualifications
- Education: Bachelor’s degree in a relevant scientific discipline.
- Experience: 3+ years of GxP quality experience with direct vendor/CRO/CMO oversight and/or auditing (GLP/GCP/GMP).
- Knowledge: Demonstrated knowledge of one or more of the following—ICH (e.g., E6(R2)/E8(R1)/Q9(R1)), OECD GLP, FDA, EMA, EU Annex11/21CFRPart11, and data integrity (ALCOA+).
- Communication & Negotiation: 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; excellent organizational skills with respect to planning, tracking, and timelines; demonstrated knowledge of QMS implementation and regulatory frameworks; 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 Plasma Inc.
At CSL, we pride ourselves on being an exceptional employer, offering a collaborative work culture that fosters innovation and professional growth. Our commitment to employee development is reflected in our comprehensive training programmes and opportunities for cross-functional collaboration, particularly in the vibrant setting of our R&D facilities. Join us to be part of a team that values quality, integrity, and continuous improvement, while making a meaningful impact in the biopharmaceutical industry.
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 land you that dream job.
✨Tip Number 2
Prepare for interviews by researching the company and its culture. We recommend practising common interview questions and tailoring your answers to highlight your experience with vendor oversight and quality assurance. Show them you’re the perfect fit!
✨Tip Number 3
Follow up after interviews! A quick thank-you email can go a long way in keeping you top of mind. We suggest mentioning something specific from your conversation to remind them why you’re the ideal candidate for the role.
✨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, so make sure you’re in the mix!
We think you need these skills to ace GMP Vendor Oversight and QA Lead in Maidenhead
Some tips for your application 🫡
Tailor Your CV:Make sure your CV reflects the skills and experiences that align with the GMP Vendor Oversight and QA Lead role. Highlight your GxP quality experience and any relevant vendor oversight or auditing work you've done.
Craft a Compelling Cover Letter:Use your cover letter to tell us why you're the perfect fit for this role. Share specific examples of how you've successfully managed vendor relationships or led quality assurance initiatives in the past.
Showcase Your Communication Skills:Since effective communication is key in this role, make sure your application showcases your ability to convey complex information clearly. Use concise language and structure your application well to demonstrate your organisational skills.
Apply Through Our Website:We encourage you to apply directly through our website. This way, you can ensure your application reaches us quickly and you’ll have access to all the latest updates about the role and our company.
How to prepare for a job interview at CSL Plasma Inc.
✨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. 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.
✨Ask Insightful Questions
Prepare thoughtful questions about the company's vendor management processes and quality assurance practices. This not only shows your interest but also gives you a chance to assess if the company aligns with your values and work style.
