Job purpose:

The Compliance Manager is responsible for ensuring that the site complies with all applicable laws, regulations, and internal policies. This role plays a crucial part in managing risk by developing and implementing compliance programs, conducting audits, and overseeing corrective actions. The Compliance Manager leads initiatives to train staff on compliance standards, maintain governance processes, and ensure the site is audit-ready at all times. This role is instrumental in promoting a strong culture of compliance and ethical practices across the Yusen Logistics Distribution Center.

Your responsibilities:

• Collaboration with Internal and External Teams: You closely work with Yusen Logistics personnel and GSK staff at the Gembloux site to ensure a continuous and compliant supply of vaccines, adhering to GMP/GDP regulations and GSK QMS quality standards.
• Leadership and Team Building: You lead a multidisciplinary team by defining roles, responsibilities, and objectives, while fostering an environment that encourages motivation and teamwork.
• Compliance Governance: You drive local governance processes to maintain a high compliance standard at the site, ensuring adherence to all relevant regulations.
• Deviation and CAPA Management: You oversee deviation and Corrective and Preventive Actions (CAPA) processes, ensuring that effective methodologies are followed to manage and resolve deviations in a timely manner.
• Training and Development: You proactively manage and coordinate organizational training programs to ensure staff perform their tasks in full compliance with applicable requirements (GxP, GSK standards, etc.).
• Standard Operating Procedures (SOPs): You write and update Local Standard Operating Procedures (LSOPs) in line with GSK standards, systems, and cGMP/CGDP regulations to ensure consistency and regulatory compliance.
• Quality Systems Management: You ensure proper and timely execution of Quality Systems, including LSOPs, deviations, CAPA, gap assessments, change controls, internal audits, and training programs.
• Support to Aviation Security Compliance: You assist the Aviation Security Manager to ensure site compliance with the regulations set by the Directorate General for Air Transport (DGTA).
• Audit and Inspection Readiness: You ensure that the site remains prepared for internal and external audits, offering expert support during inspections and audits to maintain compliance.
• Escalation of Critical Issues: You promptly escalate critical issues to the Head of Warehouse, VDO Global Compliance Manager, and/or VDO QA Manager to ensure swift resolution.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Bachelor/Master degree or previous related experience.
• Significant experience in compliance related role(s) in a vaccines, biopharmaceuticals or scientific environment
• Ability to lead a team, develop people, set direction, focus on priorities, and inspire.
• Fluent in spoken and written English and French both /technically as well as conversational.
• Experience in writing and updating LSOPS in accordance with GSK standards/systems and GMP/GDP regulations.
• Experience in deviation, CAPA and change control management.
• Experience in dealing with internal and external audits.
• GMP/GDP expertise
• SAP expertise
• Influencing skills, charism and leadership to represent YLDC in meetings and act as expert during inspections.
• Rigor and pragmatism

#Li-GSK  #GSKVaccines

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.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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