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 / TechnicalKnowledge

• 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