GMP Vendor Oversight and QA Lead
Location: Maidenhead
Time Type: Full time
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:
1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
About CSL Seqirus
CSL Seqirus is part of CSL. As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S., the U.K. and Australia, CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.
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 the company portal.
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