Job Title : 3R Program Manager
Location : 1330 Rixensart+1 location
Company : GSK
Salary :
Open Date : 2023-02-11
Close Date : 2023-06-11
Site Name: Belgium-Wavre, Belgium-Rixensart
Posted Date: Feb 10 2023
3R Program Manager

Job purpose

Responsible of the deployment of internal 3R activities linked to GSK Quality sites for all portfolio life cycle products, future products and starting materials. Management of 3R projects in Quality includes:

• Expertise / Technical Knowledge within respective area especially replacing DTaP animal potency testing

• Network Management

• Project Ownership

• Internal and external advocacy to maximize acceptance of 3R within industries and regulators

In this role you will…

Expertise / Technical Knowledge

• Represent GSK in internal and external boards and communications linked to animal use, 3R and animal welfare via trade associations, health authority contacts, collaborative studies and scientific conferences

• Support site in implementation of GSK Vaccine requirements and monitor site implementation status. Accountable to drive the DTaP IVRP project implementation. Plan and coordinate laboratory activities for the development of new immunoassays in close collaboration with local QC and ARD validation and release team

• Coordinate the different activities between physico and Immuno assays development in GIO, QC and R&D and align the project deliverables with GSK strategy and R&D future products

• Maintain current knowledge of global regulations and guidance, global regulatory expectations, novel animal free methods, industry standards and registered risks pertaining to 3R and animal testing replacement

• Lead or Support projects and other activities in non-animal methods in R&D, Quality and GIO, partnerships Ensure quality oversight of all activities related to 3R and animal testing replacement e.g. define GSK vaccine requirements and set policies and standards which are implemented through QMS, VSOPs, technical standards or other means (e.g. CAPA globalization, assess requirements and propose global/local actions to avoid re-occurrence)

• Ensure compliance with external and internal requirements in the area of3R and animal testing replacement (e.g. GSK QMS, GSK Vx VSOPs) through interaction with internal organization Internal control, Std compliance with MCB, Pharmacopeia compliance

• Provide expertise support (e.g. inspections preparation and regulatory submissions, writing, risks, owning eCC, deviations, improvement initiatives, remediation, CAPA globalization, Quality Alerts) as well as development and delivery of training materials

Network Management

• Manage external network of Key opinion leaders from critical Health Authorities and competitors to ensure harmonization were feasible and ensure acceptance of GSK strategy were not

• Manage internal network of local and global experts and ensure sharing of best-practice and learnings in 3R and animal testing replacement

• Manage and maintain relationship with GSK experts from other Departments (e.g. Preclinical R&D, Technical R&D, GIO, MSAT)

• Develop mid / long term vision within network

• Build the local expert network and mentor/coach local experts

Process Ownership

• Accountable to drive the execution of global vaccines strategy to minimize animal testing in Quality and improve in R&D

• Deploy process throughout network and ensure standardization/harmonization at the appropriate level

• Monitoring – Accountable to collect and analyze assessment criteria on the system effectiveness and performance (incl. trend analysis) and report to senior management as well as to competencies in the network

• Drive continuous improvement

• Own and maintain applicable global Vaccines procedure (e.g. VSOPs, Position Papers), tools, templates and other documents

• Knowledge management: own applicable libraries, repositories etc.

This job opportunity is a permanent contract not opened for relocation.

Why you?

Qualifications & Skills

• Master in Biological Sciences, Biochemistry, Pharmaceutical Science, medicine or related field

• 5+ years of experience in a technical field related to Quality control and animal test replacement

  • Experience with development of analytical methods of biological products, including usage of novel alternatives to animal methods.

  • Experience with cGMP or other quality system regulations. Experience with senior stakeholder management and external experts.

  • Experience in project management with strategic visions.

• In depth knowledge and expertise of 3R and linked areas.

• Ability to communicate across all organizational levels and with teams where English is not their first language.

• Ability to manage networks and build relationships transversally across the Vaccines network and beyond.

• Customer focused; ability to understand requirements of local sites and supply

• Proficiency in English and French

Preferred Qualifications & Skills:

• Reliable individual -a change agent-, with strong managerial and leadership skills; ability to influence at all levels of the organization.

• Strong presentation skills.

• Good understanding of vaccines or similar biologics manufacturing and controls (primary and secondary operations) as well as raw material manufacturing technologies.

• Good knowledge of quality and risk management principles and tools.

• Flexible, proactive and strategic thinking. Passion for improvements.

• Ability to adapt, work under uncertainty and accommodate flexible work demands.

• Willing to travel abroad; travel: (10-20%)

Why GSK?

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 organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

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.

Find out more:

Annual Report 2021

#Li-GSK

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.

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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

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