Cold Chain and Distribution Senior Quality Manager

Ready to help shape the future of healthcare? Your talent can bring our science to life!

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Job purpose :

• Ensuring GSK and regulatory requirements for distribution are implemented within supply chain logistics.

• Leading the definition of cold chain strategies and guidelines across the network.

In this role, you will...

• Lead and implement a Quality and Compliance improvement mind-set within the Supply Chain organization and manufacturing network for cold chain and distribution management.

• Act as SME for Cold Chain related topics across the network; create, review and/or approve GSK Cold Chain management principles and processes. Be an active member of Cold Chain Technical Life Cycle Team (TLCT). Provide training, guidance and technical support to GSK user sites, as required.

• Review, assess and approve documentation related to distribution oversight (e.g. DRAs, LSPs or route assessment) and qualification (e.g., insulated packaging systems, temperature controlled active systems, Physical integrity qualification, monitoring devices, etc.).

• Be the Quality partner in distribution related projects, actively participating in the definition of targets and provide support for reaching the milestones within the agreed timelines.

• Ensure GDP service providers (e.g. LSP) are aligned with Quality GSK and regulatory requirements; lead quality oversight of GDP service providers e.g. Quality Agreements management & approval, business reviews attendance, audits performance/support including follow up, KPI review and trend analysis performance.

• Be the quality partner of cold chain and distribution related teams i.e. participation to sub-team compliance meeting(s), review/approval of change controls, review and/or approval of guidance/procedures/WoW and review and approval of deviations including definition and implementation of CAPA where needed. Ensure inspection/audit readiness; participation to inspections/audits and related follow up as applicable.

• Act as Quality partner with QC representatives (Thermostability Group) for application and use of stability data in Vaccines Sites (Manufacturing), Business Process (IT), Distribution and HCP (Medical Affairs). Define Thermostability and ToR management strategy and principles and respective implementation

Why you?

Technical Skills & Qualifications :

• Bachelor or Master’s degree in Sciences/Engineering/Pharmacy

• Extensive experience in pharmaceutical/ vaccines manufacture, release & distribution.

• Experience in cold chain and distribution.

• Good understanding of ICH Q10 Pharmaceutical Quality Systems.

• Good understanding of how cold chain strategy and distribution requirements is implemented within global supply chain.

• Knowledge of global regulations and guidance, global regulatory expectations, inspection intelligence, innovative/new technologies, industry standards and registered risks pertaining to area of expertise.

• Fluency in English (global scope and interactions)

Soft Skills & Qualifications:

• Excellent written and verbal communication skills.

• Stakeholders management and leadership skills (influence, decision making)

• Ability to work across many different cultures, functions and manufacturing/ distribution operational areas, therefore a good span of knowledge would be advantageous.

• Experience in projects linked to supply chain improvements is preferred

• Agility & Business Acumen

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 special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

 
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