Site Name: Wavre Posted Date: Jun 24 2024 Job purpose: The role provides leadership and direction to ensure the Quality R&D operates in compliance with GSK standards. As Quality Compliance Director R&D you, Lead Quality performance and compliance for the RD GxP areas, monitoring the KPI Performance and initiating action as required. Ensure incidents are appropriately escalated, managed, and communicated Provide support in assessing the impact of critical deviations Ensure the Quality risks for the RD GxP areas are identified understood and managed and that a Quality Risk Model is developed and used to effectively identify and manage risk Your responsibilities: Support the implementation of the quality strategy for R&D Quality. Contribute to quality performance and culture ensuring adverse trends in compliance dashboards are investigated and action taken. Support site inspections as required. Oversight/ Chair for Quality governance (e.g. PIRC, ICF committee….) process ensuring incidents are properly escalated and managed and support key quality decisions. AL3 chair (where there is not an aligned PQL for the product) Accountable for the Tier 2 Quality Council/ICF council process for R&D Quality ensuring agenda and escalation are appropriate to drive improvement and mitigate risks. Ensure that QC process is continuously improved. Accountable for the Quality Performance meeting ensuring that all the quality metrics are understood, trend identified and resolved, and status of compliance improved, including leading Quarterly Deviation Trend review and coordinating regional CAPAs and actions (as an example A&A audit has CAPAs which is applicable to all Vaccines Sites) Own the quality and compliance governance processes required by the QMS, e.g. Quality Council, Risk Management, Quality Risk Model and LIC/PIRC processes. Accountable for the tracking of risks, Quality Risk Model Process for vaccines – lead the QRM Gemba and ensure that sites progress improvement plans. Lead DI CoP and track the progress on DI plans Communicate with other functions and providing Regional inputs (Inputs to draft Quality Alert, Monthly PRS Meeting, Monthly QMS Tier1, etc.) Additional information: Reporting line: Head QRD Number of positions available: 1 People management (direct/indirect reports, etc.): no Business travel requirements: 10% Primary location: Wavre, Belgium Secondary location: Europe. Applications from candidates located close to strategic vaccines locations will be considered on a case-by-case basis. No relocation support provided. Application closing date: Monday July 15th, 2024 EOB Why You? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Minimum BA/BS degree level in Biological Sciences, Chemistry, Pharmacy or related scientific disciplines Minimum 10 years of experience in Quality in a highly regulated environment Experience in Product Quality and Compliance Knowledge of cGMP globally Knowledge of CEP products Knowledge and application of the QMS Knowledge of OE tools and KPI management Ability to influence teams and to drive change Ability to standardize and work across boundaries Fluency in English both written and spoken Preferred Qualifications: If you have the following characteristics, it would be a plus: Master’s degree level or higher in Biological Sciences, Chemistry, Pharmacy or related scientific disciplines Business Management degree e.g. MBA Knowledge of GCP Application closing date: Monday July 15, 2024 EOB Please take a copy of the Job Description, as this will not be available post closure of the advert. #LI-GSK If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements. 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