Contracting – Walloon Brabant Our partner is currently looking for a Vendor Quality Lead to join its team. This international company is well-known for its pharmaceuticals. This position will provide leadership and in-depth QA expertise in driving strategic and operational Quality Assurance activities associated with complex Global Vendors (Contract Manufacturing Organizations) engaged in GMP manufacturing activities for the company Products. Vendor Quality Lead (VQL) related accountabilities: Be the central QA point of contact for the organization for investigations / deviations / out-of-specifications / audit observations associated with the assigned vendors. Perform the QA review of deviation notifications, retrieve and collect supportive information from involved stakeholders to allow assessment. Manage the key performance indicators (metrics) for key operational QA activities and services associated with the vendors in the defined described tracking tools (Vendor QA KPI tracker, QuickScore) and track the vendor's performance Ensure all Quality agreements are in place and take ownership of agreements for the vendors. Maintain Quality Agreement with the vendors up to date and perform periodic reviews and update of the agreement in close collaboration with the vendors. When applicable, be sure that the Annual Product Stability Program is rolled-out and executed at the vendor in accordance with the company Stability Program Ensure the Product Quality Reviews (PQR) are completed by the vendors in a timely manner and as needed and are reviewed within the requested time period. Ensure that this review is documented and made available in the internal Controlled Documents System. Participate as QA representative to the recurrent vendor meetings, present issues and resolutions, and drive vendor quality performance through these meetings Quality Complaints: be the contact person for the follow-up with vendors for the manufacturing investigation part. When applicable, ensure that initial receipt, logging of quality complaints into the company Complaint System and provision of responses to the complainant are professionally coordinated and managed. If needed work with the Vendor team and CMC Quality Lead to determine the Root cause of issues which may lead to a Corporate Technical Review (CTR) meeting. Coordinate vendor quality related investigations Participate on ad-hoc basis to the company Product Change Control Committees for activities related to the vendors Provide in-depth expert QA advice, support and management for technical operational QA and general QA strategic matters associated with the vendors Work closely with Global QA teams, Technical Operation Teams, Business stakeholders and Affiliates in an effective and efficient way Cover the entire product life cycle from initial commercialization including Technology Transfer/Knowledge transfer, commercial (key raw materials to distribution), product improvements to phase out for the assigned vendors Developer and owner of the QA plans and product resource and capacity overview for activities associated with the assigned vendors Ensure all relevant documentation are provided to the vendors and implemented (Methods, Specs, Master Batch record) Ensure review of relevant RA dossier section related to the assigned vendors Have the overview of the company audit and HA inspections related to the vendors. Track and follow-up on Audit observation and CAPA plan implementation at the vendor. Be the QA stakeholder for Vendor Risk management. Manage and control quality documents related to the vendors in the Controlled Documents System Support on customer audits and Health Authority inspections at the vendors, as needed Receipt, coordinate review and authorize product reworks and repackaging Drive resolution for complex quality issues related to the vendors in scope including coaching other VQL's on problem solving for complex issues. Be the point of contact for critical post-release vendor issues (supply chain, distribution, etc.). Challenge current practices for issue resolution and incorporate new perspectives into existing problems. As required provide Operational QA support to other vendors Act as substitute for other Vendor Quality Leads in times of absenteeism (e.g. vacation, illness) Acts as a coach for VQL's with less experience. Work in accordance with internal HSE and Corporate policy requirements and drive personal training and development activities to meet the needs of the business and professional career development. Acts as a Best Practice ambassador, leads best practices steams and uses knowledge of internal/external business environment to improve existing process. Master's degree in Life Sciences, Engineering, or a related field Experience in Quality Assurance. Experience in vendor management. Experience with Quality Management Systems (QMS) in pharmaceutical manufacturing environments. Knowledge of aseptic manufacturing processes. Must be knowledgeable in several areas of the global pharmaceutical industry, including the interpretation and practical application of applicable regulations. Has good background knowledge of the pharmaceutical industry from a business and technical perspective. Must be able to work independently and handle complex / difficult situations. Output from actions will most likely impact activities across several departments. Possess good auditing capabilities and skills. Must be able to effectively interact with and influence senior internal and external personnel on many aspects of project and product related matters. Must possess excellent interpersonal, verbal, and written communication skills at all levels internally and externally especially at senior... Technology transfer, Senior management, Pharmaceuticals, Corporate Culture, Quality Issues, Minute taking, Improve Product, Driving, Business, Tracking Tools, Audit, Manufacturing, Masterbatch, Coaching, Problem Management, Supply chain, Complex Issues, Investigations, Projects, Ensuring Quality, Policy, Coordination, Risk Management, Support Management, Leadership, Quality Reviews, Personal Training, Career Development, ACT!, Quality Control, Vendor Management, Ad Hoc Work, Writing Skills, Product Quality, Quality assurance, Notifications, Business Needs, Audit, Vendors, CMC, Implementation, Assessment Skills, KPI, Expertise, GMP, Documentation, PLM, Health System, Knowledge Transfer, Company Products, Taking Ownership, Audit Observations, Stakeholders, Affiliate marketing, Quality assurance, Company Products, Inspection, Investigations, Client Audit, Practicality, Regulation, Company Audit, Raw material, Marketing, Engineering, VOS, Metric, Best Practices, Life Science, Committees, Customer support, KPI, Knowledgeable, Point of contact, Service, Accountability, Root Causes, Change Control, Quality assurance, Problem Management, CAPA, Distribution, Peer support Originele vacature is te vinden op StepStone.be – Maak nu een Jobagent aan op StepStone en vind je droombaan! https://bit.ly/2jPYsZC Vind gelijkaardige jobs, informatie over werkgevers en carrièretips op StepStone.be! 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