Auditor - Audit and Quality Compliance (6 months)

Auditor  - Audit and Quality Compliance (6 months contract)

Job purpose :

• Carry out an independent quality oversight across the Belgium organization (MPUs, Shared Services and NPI) by leading transversal internal audits in order to assess sustainability and compliance of our operations with cGMP expectations ; risk management / escalation and governance processes

• Identify and communicate to the management any issues that impact product quality, safety or efficacy, regulatory compliance or business continuity.

• Ensure effective and sustainable management of compliance issues through harmonized remedial actions and improvement plans.

In this role, you will...

• Organize and lead transversal GMP audits within the Belgium organization - commercial activities and NPI - to assess compliance with QMS standards / cGMps requirements and identify issues ; highlight un-harmonized practices and identify best practices to be shared throughout the Belgium organization

• Carry out independent review of topics identified on a risk based analysis in the relevant part of the organization

• Oversee remediation activities of the auditees to ensure compliance to the GSK Quality Management System and cGMPs requirements within the Belgium organization ( commercial activities and NPI )

• Accountable to propose and ensure implementation of actions to achieve or maintain the in use status of the quality standards taking into account the quality requirements and the cost awareness.

• Develop and instill a mindset oriented towards continuous improvement of quality, ensuring the right balance between the compliance expectations and an control excessive

• Verify robustness and sustainability of the remediation activities

• Communicate outcomes of the audits related to significant quality or compliance issues to internal stakeholders through appropriate escalation processes.

• Develop, through coaching, the expertise and auditing skills of the auditors in the Belgium network.

• Support regulatory inspection preparation activities: pre-audit, facilitation during inspection.

• Remain current with industry trends and changes in the regulatory and GMP standards.

Why you?

• University degree in Sciences

• Broad experience in pharmaceutical / Biological environment covering various area: QA, production, QC with managerial and project management roles.

• Strong knowledge of regulatory and GMP regulations (European, US, Japanese, WH0 ...).

• Demonstrated leadership ability and experience in influencing improvement activity to ensure implementation of appropriate CAPAs

• Familiar with Lean/Six Sigma tools

• Qualified / Certified auditor is a plus – demonstrated lead auditor skills

• Communications skills to ensure issues, risks and opportunities are well understood and that effective actions are put in place

• Fluent in French and English ( written and spoken )

• Demonstrated ability to function effectively across a complex organization

• Knowledge of technologies used in the (bio)pharmaceutical business

Application closing date: Friday 09 May 2025

Please take a copy of the Job Description, as this will not be available post closure of the advert.

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.

 
Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.