Quality Compliance Director, Vaccines

<p></p><p><b>Job purpose:</b></p><p></p><p>The role provides leadership and direction to ensure the Vaccines Quality operates in compliance with GSK standards.</p><p></p><p>As Quality Compliance Director Vaccines (Vx), you</p><ul><li><p>Lead Quality performance and compliance for the operational business unit, monitoring the KPI Performance and initiating action as required.</p></li><li><p>Ensure incidents are appropriately escalated, managed, and communicated to the authorities.</p></li><li><p>Provide support in assessing the impact of critical deviations.</p></li><li><p>Ensure the Quality risks for the business unit products are identified understood and managed and that the Quality Risk Model is used to effectively identify and manage risk.</p></li><li><p>Act as the Business process owner interface for quality systems and processes, partnering with quality leaders across global teams.</p></li></ul><p></p><p><b>Your responsibilities: </b></p><ul><li><p>Support the implementation of the quality strategy for Vaccines Quality.</p></li><li><p>Contribute to quality performance and culture ensuring adverse trends in compliance dashboards are investigated and action taken.  Support site inspections as required.</p></li><li><p>Oversight/ Chair for PIRC and LIC process ensuring incidents are properly escalated and managed and supports key quality decisions.</p></li><li><p>AL3 chair (where there is not an aligned PQL for the product)</p></li><li><p>Local business owner for enterprise quality systems, a key interface between Vaccines quality and Quality Systems and Data team.</p></li><li><p>Accountable for the Tier 2 Quality Council process for Vaccines Quality, and leads Regional Quality RMCB ensuring agenda and escalation are appropriate to drive improvement and mitigate risks. Ensure that QC process is continuously improved.</p></li><li><p>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&amp;A audit has CAPAs which is applicable to all Vaccines Sites )</p></li><li><p>Support sites in effectively deploying the GSK Quality Management System (QMS) and owns the quality and compliance governance processes required by the QMS, e.g. Quality Council, Risk Management, Quality Risk Model and LIC/PIRC processes.</p></li><li><p>Accountable for the tracking of risks, Quality Risk Model Process for vaccines – leads the QRM Gemba and ensures that sites progress improvement plans.</p></li><li><p>Lead DI CoP and track the progress on DI plans</p></li><li><p>Communicate with other functions and provide Regional inputs (Inputs to draft Quality Alert, Monthly PRS Meeting, Monthly QMS Tier1 etc)</p></li></ul><p></p><p><b>Additional information: </b></p><ul><li><p>Reporting line: VP Quality Vaccines</p></li><li><p>Number of positions available: 1</p></li><li><p>People management (direct/indirect reports, etc.): no</p></li><li><p>Business travel requirements: 10%</p></li><li><p>Primary location: Wavre, Belgium</p></li><li><p>Secondary location: Europe. The successful candidate will ideally be based in Wavre, Belgium. Applications from candidates located in strategic vaccines locations will be considered on a case-by-case basis. No relocation support provided.</p></li></ul><p></p><h1><b>Why You?</b></h1><p></p><p><b>Basic Qualifications:</b></p><p>We are looking for professionals with these <u>required</u> skills to achieve our goals:</p><ul><li><p>Minimum BA/BS degree level in Biological Sciences, Chemistry, Pharmacy or related scientific disciplines</p></li><li><p>Minimum 10 years of experience in Quality in a highly regulated environment</p></li><li><p>Experience in Product Quality and Compliance</p></li><li><p>Experience in Manufacturing Operations</p></li><li><p>Knowledge of cGMP globally</p></li><li><p>Knowledge of CEP products</p></li><li><p>Knowledge and application of the QMS</p></li><li><p>Knowledge of OE tools and KPI management</p></li><li><p>Ability to influence teams and to drive change</p></li><li><p>Ability to standardize and work across boundaries</p></li><li><p>Fluency in English both written and spoken</p></li></ul><p></p><p><b>Preferred Qualifications:</b></p><p>If you have the following characteristics, it would be a plus:</p><ul><li><p>Master’s degree level or higher in Biological Sciences, Chemistry, Pharmacy or related scientific disciplines</p></li><li><p>Business Management degree e.g. MBA</p></li></ul><p></p><p><b>Application closing date:</b> <u>Monday July 15, 2024 EOB</u></p><p></p><p>Please take a copy of the Job Description, as this will not be available post closure of the advert.</p><p></p><p>#LI-GSK</p><p><span>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 r