Sr. Principal Quality Advisor, Vendor Assessment
3 months ago
Responsibilities
- Plan, coordinate, execute and manage the global supplier qualification programme, ensuring the programme is risk-based, robust, justifiable and efficient.
- Maintain Resolian’s Global Supplier Database
- Action new supplier requests
- Assess new suppliers according to Resolian’s risk-based criteria
- Perform periodic supplier assessments as per Resolian’s schedule
- Monitor and report metrics on supplier sustainability
- Lead periodic meetings with high risk suppliers
- Lead the reporting of complaints and other supplier issues.
- Participate in external sponsor audits on matters related to supplier qualification and feedback comments into process improvements.
- Build effective relationships with suppliers and act as a point of focus for external communications.
- Liaise with clients and internal stakeholders in the preparation and execution of quality agreements.
- Maintain regulatory agency registrations (FDA, EMA, DUNS, etc) as required.
- Perform study, process and facility audits as required according to the audit program and study deadlines.
- Maintain a strong knowledge of the current regulations and guidance.
- Investigate and resolve supplier CAPAs.
- Work with QA and Operational teams across Resolian to enhance, improve and drive efficiencies across the group.
- Act as the contact point for client quality agreements, and regulatory agency registrations, ensuring documentation is accurate and current.
Skills, Education & Qualifications
- Strong knowledge and understanding of working within a GxP or ISO regulated environment and their application.
- Demonstrable audit skills that can be practicably applied to auditing activities as a sole auditor or as part of a team.
- Experience of establishing audit scope and developing relevant audit schedules and checklists.
- An understanding of the function of the QMS and actively supporting QMS systems such as Deviations, OOS, Change Control and CAPA.
- Able to demonstrate strong customer (internal and external), supplier and regulator interaction skills.
- Experience working within the pharmaceutical industry is preferable.
- Minimum level of BSc in scientific field or recognised auditor certification, or equivalent industry experience
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