Quality Compliance Director – Biologics & Devices

Quality Compliance Director – Biologics & Devices (B&D) This role can be based in London, UK or at other strategic GSK locations in Europe and US on a case-by-case basis. 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. 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, and that the Quality Risk Model is used to effectively identify and manage risk. 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. Support site inspections as required. Oversight/ Chair for PIRC and LIC process ensuring incidents are properly escalated and managed and supports key quality decisions. AL3 chair (where there is not an aligned PQL for the product). Local business owner for enterprise quality systems, a key interface between B&D quality and Quality Systems and Data team. Accountable for the Tier 2 Quality Council process for B&D 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. Accountable for the Quality Performance meeting ensuring that all the quality metrics are understood, trends identified and resolved, and status of compliance improved, including leading Quarterly Deviation Trend review and coordinating regional CAPAs and actions. Why you? Basic Qualifications & Skills: We are looking for professionals with these required skills to achieve our goals: 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 not necessary, just preferred, if you do not have them, please still apply: 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, with comfort cooperating with individuals internally and externally at all organisational levels. Experience setting goals and driving results, defining priorities, managing and influencing individual and team performance. Fluency in English both Written and Spoken. Closing Date for Applications – 4th February 2025 Please take a copy of the Job Description, as this will not be available post closure of the advert. When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application. As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, 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 (US only). We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

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