Quality Compliance Director - Biologics & Devices
Site Name: Evreux, GSK HQ
Posted Date: Mar 26 2025
The role provides leadership and direction to ensure the Biologics & Devices Quality operates in compliance with GSK standards. It will report into the VP, Quality Biologics & Devices.
Responsibilities
As Quality Compliance Director B&D, you:
* Lead Quality performance and compliance for the operational business unit, monitoring the KPI Performance and initiating action as required.
* Ensure incidents are appropriately escalated, managed, and communicated to the authorities.
* Provide support in assessing the impact of critical deviations.
* Ensure the Quality risks for the business unit products are identified, understood and managed.
* Act as the Business process owner interface for quality systems and processes, partnering with quality leaders across global teams.
In this role you will:
* Support the implementation of the quality strategy for B&D Quality.
* Contribute to quality performance and culture ensuring adverse trends in compliance dashboards are investigated and action taken.
* Oversight/ Chair for PIRC and LIC process ensuring incidents are properly escalated and managed and supports key quality decisions.
* Local business owner for enterprise quality systems, a key interface between B&D quality and Quality Systems and Data team.
* Accountable for the Quality Council process for B&D Quality, ensuring agenda and escalation are appropriate to drive improvement and mitigate risks.
* Accountable for the Quality Performance meeting ensuring that all the quality metrics are understood, trend identified and resolved.
Basic Qualifications & Skills
We are looking for professionals with these required skills:
* Degree qualified in Biological Sciences, Chemistry, Pharmacy or related scientific disciplines.
* Significant experience in a Quality in highly regulated environment.
* Experience in Product Quality and Compliance.
* Experience in Manufacturing Operations.
* Knowledge of cGMP globally.
* Knowledge of CEP products.
* Knowledge and application of the QMS.
* Strong stakeholder management and influencing capabilities.
Preferred Qualifications & Skills
Please note the following skills are preferred:
* MSc or PhD or other Chartered / Professional Qualification in Biological Sciences, Chemistry, Pharmacy or related scientific disciplines.
* Knowledge of OE tools and KPI management.
* Excellent management, communication and interpersonal skills.
* Experience setting goals and driving results.
* Fluency in English both Written and Spoken.
Please take a copy of the Job Description, as this will not be available post closure of the advert.
GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
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