Senior Specialist Extractables

**Site Name**: Belgium-Wavre, UK - County Durham - Barnard Castle
**Posted Date**: Oct 2 2025

Job Purpose
- The job owner has a GSME role in Extractables & Leachables.
- The job owner acts as primary GSME support for Medicines Large Molecules & Vaccines division including related CMOs.
- The job owner aligns the E&L GSC strategy with R&D, who are accountable for new product development and commercialization, aiming for a smooth transfer of commercial products.
- The job owner will conduct and document E&L risk assessments for biopharmaceutical manufacturing processes, container closure systems and dosing device (an interim until LSME network in Medicines Large Molecules division is in place and in use.)
- The job owner has the task to create and/or update the relevant internal standards (GQP, GQSOP, GG etc.) related to E&L strategy deployed in GSC.
- The job owner benchmarks internally and externally in the domain of expertise.
- The job owner will advocate GSK E&L position externally through international working groups (A3P, ISPE, BPOG, ) and/or conferences.
- The job owner manages risks escalation to the different parts of GSK.
- This job aims at providing expertise and supporting the GSK network.
- The job owner must deliver key technical information to business partners, to support business decisions and/or regulatory filings.
- The job owner will work with internal and external laboratories to ensure E&L testing is delivered in a scientific, compliant and cost effective manner.
- The job owner will participate to MSA process of GPROC to set up technical agreements and technical audits with potential E&L lab suppliers.
- The job owner will interact directly with regulatory agencies during audits to present E&L GSK strategic topics.
- The job owner acts as key contact person for Quality Regulatory Intelligence activities.
- The job owner defines the expertise’s lifecycle strategy.
- The job owner establishes the expertise’s lifecycle strategy.

Key Responsibilities

**Expertise /**Technical** **Knowledge**
- Monitor and assess new developments, industry trends, evolving regulatory expectations in area of expertise
- Represent GSK in internal and external boards and contribute to the development of new standards
- Maintain current knowledge of global regulations and guidance, global regulatory expectations, inspection intelligence, innovative / new technologies, industry standards and registered risks pertaining to area of expertise
- Define GSK requirements and sets policies and standards which are implemented through QMS, GQSOPs, technical standards or other means (e.g. assess requirements and propose global/local actions to avoid re-occurrence)
- Ensure compliance with external and internal requirements (e.g. GSK QMS, GSK GQSOPs) through interaction with internal organization
- Support sites in implementation of GSK requirements
- Lead or Support projects and other activities (e.g. ownership of transversal risks) in Quality and GSC, partnerships and Joint Ventures
- Provide expertise support (e.g. inspections preparation and response writing, risks, observations, deviations, improvement initiatives, remediation, Quality Alerts)

**Network Management**
- Be part of GSK E&L experts team
- Develop mid / long term vision and strategy within network
- Support sites to assess need for escalation to relevant Quality Council (if issue is applicable to other sites)
- Share global learnings through CoP

**Process**Ownership**
- Accountable to drive global strategy in area of expertise
- Define GSK system / process mandatory standards in compliance with GSK QMS requirements
- Deploy process throughout network and ensure standardization/harmonization at the appropriate level
- Drive continuous improvement
- Own and maintain applicable global procedure (e.g. GQSOPs), tools, templates, and other documents
- Own applicable libraires, repositories etc.
- Deploy digitalization in his/her field of expertise

**_ Why You_**:
Basic Qualifications
- At least 4+ years of working experience required in one of the following: E&L, Validation
- Risk Management
- Regulatory knowledge related to the specific expertise
- Strong technical writing skills
- Benchmarking skills
- EHS-awareness
- Proficient in both written and spoken English

Preferred Qualifications
- Strong interpersonal and communication skills
- Demonstrated ability to work effectively across a diverse customer base
- Awareness of FDA, US Pharma and Good Manufacturing Practices (GMP) requirements related to packaging
- Ability to work effectively in a matrix organization across geographies and cultures
- Teamwork ability
- Networking and facilitation skills
- Coaching, mentoring, training
- Problem solving attitude
- Can-do spirit
- Customer focus
- Able to propose solutions in critical situations
- Prioritization skills
- Execution & coordination skills in validation
- Supplier interface

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