3r Program Manager

il y a 4 semaines

Wavre, Belgique GSK Temps plein

**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.

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