We are hiring a Vendor Quality Lead (VQL).
In this role, you will act as the central QA point of contact for the quality management of assigned vendors. Below are the key accountabilities:
* Ensure all Quality Agreements are in place and take ownership for the vendor(s). Maintain agreements up to date, performing periodic reviews in collaboration with internal stakeholders and the vendor(s).
* Ensure all relevant documentation (methods, specifications, process descriptions, etc.) is provided to vendors and implemented according to Quality Agreement requirements.
* Act as central QA contact for:
* Investigations, deviations, out-of-specifications linked to assigned vendor(s),
* Change Controls,
* Perform QA review and approval of related records, collecting supportive information from stakeholders. Ensure reviews are documented and stored in the Controlled Documents System.
* Drive resolution for complex quality issues related to vendor(s), including coaching other VQLs. Act as contact for critical post-release vendor issues. Challenge practices and propose improvements.
* Collaborate with Vendor team and Quality Leads to determine root causes and coordinate vendor-related quality investigations.
* Participate ad-hoc in Product or Global Change Control Committees for vendor-related activities.
* Manage KPIs for QA activities linked to vendor(s) with support of the Vendor Quality Support Team. Track vendor performance in defined tools and update the Vendor Quality Risk Score (QRS).
* Establish and follow-up reinforced Quality Plans with vendor(s) when applicable.
* Ensure Annual Product Stability Program is implemented at vendor(s) in line with company requirements.
* Ensure Product Quality Reviews (PQR) are completed by vendors on time, reviewed within deadlines, and documented in the Controlled Documents System.
* Represent QA in regular vendor meetings, present issues and resolutions, and drive vendor quality performance.
* Provide expert QA advice, support, and management for operational and general QA matters related to vendor(s).
* Work closely with Corporate QA, Technical Operations, Business stakeholders, and Affiliates effectively and efficiently.
* Act as QA stakeholder for Operational Review Meeting (ORM) preparation/discussion, Vendor Risk management, and Vendor Team objectives.
* Act as contact person for vendor follow-up on Quality Complaints (Market complaints). Ensure vendor investigations are properly managed from notification to final report.
* Support corporate audit preparation and, when required, attend audits as observer. Manage follow-up on audit observations and CAPA implementation with the Lead Auditor.
* Maintain oversight of Health Authority (HA) inspections related to vendor(s). Track and follow-up audit observations and CAPA implementation according to Quality Agreements.
* Coordinate Health Authority submission requests (Response to Questions process) with vendor team and Quality Lead.
* Ensure Audit/HA Inspection and CTR trackers are up to date for monthly KPI reporting.
* Support customer audits and Health Authority inspections at vendor(s), when needed.
* Cover the entire product lifecycle when applicable: from commercialization, technology transfer, and knowledge transfer, through product improvements to phase-out.
* Develop and own QA plans and product resource/capacity overview for activities related to vendor(s).
* Ensure relevant RA dossier sections are reviewed and communicated to vendor(s) when required.
* Manage and control quality documents related to vendor(s) in the Controlled Documents System.
* Coordinate review and authorization of product reprocessing and repackaging when applicable.
* Work in compliance with HSE and Corporate policies. Drive personal training and development activities aligned with business needs and career growth.
* Provide Operational QA support to other vendors when required.
* Act as substitute for other Vendor Quality Leads during absences.
* Act as coach for less experienced VQLs.
* Act as Best Practice ambassador, lead best practice streams, and use internal/external business knowledge to improve processes.
* Act as coach for direct reports, perform personal development discussions, manage year-end evaluations, and set objectives (if applicable).
Profile required:
* Strong Quality Assurance experience within the pharmaceutical or biotech industry.
* Proven expertise in vendor quality management, audits, inspections, and performance monitoring.
* Ability to resolve complex issues and lead cross-functional initiatives.
* Strong communication, organizational, and leadership skills.