Supplier & Im Management Systems & Processes - Wavre, België - GSK

GSK

Geverifieerd bedrijf

Wavre, België

3 weken geleden

Geplaatst door:

Sophie Dubois

beBee Recruiter

Beschrijving

Site Name:
Belgium-Wavre

Posted Date:
Jan

_ Supplier & IM Management Systems & Processes_:

Job purpose:

Ensuring compliant, reliable, integrated and innovative systems supporting the management of suppliers of materials and services within GSK Vaccines.
Successfully implementing the Quality strategies relating to supplier assessments.
Creating and improving Vaccines' supplier quality processes and control strategies for Incoming Materials in alignment with QMS and current regulatory requirements.
Representing GSK Vx quality in business initiatives currently being or planned to be implemented within GSK Vaccines
Ensuring backup from supplier regulatory compliance perspective.

You will be expected to support in creating, developing, adapting, implementing and selling the business quality processes and Strategies within Quality and the business stakeholders within GSK Vaccines manufacturing network.

In this role you will

Quality control strategy for incoming materials_
Support the Incoming material specification steering Committee
Be Global SME for incoming material specifications strategy and testing and be strongly connected with external environment
Accountable for global processes for release specification and reduced testing
Processes & systems_
Ensure and improve IM & supplier quality assurance processes (e.g. VSOP) and practices are compliant to QMS, regulatory requirements and cGMP.
Ensure digitalization and innovation to improve and simplify systems for the quality management of suppliers and incoming materials.
Ensure development, maintenance and execution of a long term L1& L2 auditing strategy within Quality Shared Service in accordance with GSK Vaccines policies.
Provide support for an integrated and robust documentation and archiving system within Supplier Quality Operation team.
Provide transversal support to the teams by organizing and providing practical trainings to all members of SQ operations and to SME network (QA IM representatives).
Design and implement effective KPI follow up system and TIER accountability.
Regulatory vigilance and benchmark_
Develop, implement and maintain systems to track and evaluate all changes in the regulatory and external environment related to IM to ensure that any issue likely to impact compliance and supply continuity are well understood and assessed. Ensure proper regulatory knowledge management within Quality shared service.
Remain current with industry trends and changes in the regulatory and external environment through established networks to ensure that any issues likely to impact the supply base are well understood and communicated in order to avoid disruption to supply.
Ensure effective knowledge and best practices sharing with external stakeholders and Pharma/Consumer Health
Ensure network building and strong partnership with all GSK Vaccines sites. Lead initiatives to enhance mutual understanding, harmonize processes and align strategies between GSK Vaccine sites in compliance with GMP requirements and appropriate levels of the GSK standards
Risk management & supplier performance monitoring:_
Support risk management by proactively identifying and mitigating potential quality and compliance risks through the risk register process.
Communicate results of investigations and/or identified risks to ensure stakeholders understand the technical, regulatory and quality risks.
Contribute to supplier risk management by performing supplier Performance risk scoring
Contribute to reinforce the supplier risk model and supplier performance monitoring within GSK Vx
Support_
Assist the Head of SQ Operations in tracking and monitoring of quality risks, issues and continuous improvement opportunities within his department. Assist in development of strategies for reducing the identified risks and introduction of improvement plans.
Provide assistance, training and workshops on processes & systems to the SME network achieve their business and quality objectives.

_ Why you? _

Qualifications & Skills:_
University degree in Chemistry, Microbiology, Biological Sciences, Pharmaceutical Science, Bio or chemical engineering, or related
Minimum 5 years' experience in pharmaceutical manufacturing and quality operations.
Proficiency and experience in planning and executing audits to identify and reduce significant risks / noncompliances
Good knowledge of technologies used within the material supply base.
Fluency in English, French is a plus
Preferred Qualifications & Skills: _
Excellent influencing and negotiating skills to ensure implementation of appropriate standards, specifications and agreements.
Excellent verbal and written communications skills to ensure effective relay of issues, risks and opportunities so that these are well understood by all parties and that effective actions are put in place.
Demonstrated ability to function effectively in a matri