This role is a 6 months contract

Job Purpose:

• Responsible for the preparation, facilitation and follow up of Quality councils, and prepare escalations to Belgium Quality council.

• Drives inspection readiness every day.

• Defines and coordinates QA oversight and L1 inspections for cluster.

• Coordinates and facilitates L2/L3/L4 inspections.

• Responsible for follow up on complaints related investigations in scope of the cluster.

• Responsible for QMS alignment.

• Accountable for collection of and distribution (where matters) of quality escalations (QEFs, transversal CAPAs, Quality Bulletins, Regulatory intelligence, …).

• Identify, drive and deliver quality performance improvement initiatives, including trending analysis.

Key Responsibilities:

• Quality Council: Prepare, facilitate, and follow up of Quality councils for each of the production units in scope.

• Ensure timely escalation to appropriate quality governances (eg Belgium Quality council). Establish and continuously improve best practices for Quality council and Quality KPI performance reviews in line with requirements and which enables appropriate and impactful decision making and escalations.

• Inspection Readiness (IR): Facilitate efficient Inspection Readiness governance for each of the production units, establish and continuously improve best practices for IR meetings. Insights from risks, quality/regulatory intelligence, Site/GSK network inspections, …, are used to proactively identify risks and mitigations. Ensure fronters are sufficiently prepared.

• Quality oversight and L1 inspections: establishes Quality oversight universe, defines plan and follows execution.

• Inspection management: Facilitation (L2 audit) and coordination (L3/L4) of audits and inspections to ensure a smooth coordination, accurate description of requests and timely follow up of responses. QMS alignment: Ensure timely follow up of QMS gap assessments and remediation and proactively use the appropriate quality governance in case of risks.

• Complaint : ensuring follow up of the investigation in scope of the cluster and drive the performance  (trending, escalation in timely manner, …)

• Quality escalation follow up: ensure timely follow up of transversal escalations (eg QEF, transversal CAPA, quality bulletin, regulatory intelligence, …) and proactively use the appropriate quality governance in case of risks. Lead quality performance improvement initiatives at cluster level by holistically reviewing performance at cluster level including but not limited to trending analysis, by identifying challenges, good practices, by doing benchmarks (in Belgium and beyond).

Why you?

Basic Qualifications:

• Minimum level of education: University level: Science, Engineering, Quality, BioEngineer.

• Minimum 5-8 years of experience in GMP environment.

Preferred Qualifications:

• Strong communication skills.

• Strong analytical skills and continuous improvement mindset.

• Strong knowledge of cGMP and guidelines (FDA/EU/WHO).

• Demonstrated impact and influence.

• French speaker with good level of written and spoken English.

Please take a copy of this job description as it won't be available after posting

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 purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

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