Senior Specialist - Extractables & Leachables (18 months contract)

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

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

For hiring in grade 7 Minimum 8 years applicable experience in biopharmaceutical manufacturing and / or experience in QA, QC, RA or GSCM within a biological environment. With at least 4+ years of working experience required in one of the following : E&L, Validation

A scenario with hiring in grade -1 is possible with a at least a 3 - 5 years experienced candidate in one of the following : E&L, Validation

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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