Senior Manager - Wavre, België - GSK

GSK

Geverifieerd bedrijf

Wavre, België

3 weken geleden

Geplaatst door:

Sophie Dubois

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Beschrijving

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Senior Manager - Global QA Aseptic Technologies Sterilizing processes:

Job purpose:

Recognized internally and externally as the quality expert on regulation, guidance and industry standards related to sterility assurance principles for sterilizing processes, APS, aseptic holding times and wrapping. Develop and give presentations at international conferences (PDA, ISPE, etc.) and influence regulators externally.

Guidance

Establish and maintain global standards, guidelines, methodologies, and knowledge repositories to ensure harmonization and use of best practices within SA domains of sterilizing process. Act as the GSK Vaccines reference to develop/revise QMS documentations with GMS partners.

Support

Provide/coordinate network technical expertise for continuous improvement and major troubleshooting not solved by local organization. Consolidate and pull technical expertise and support manufacturing improvement programs to ensure harmonization and quality across products, processes, and sites with the aim to guarantee quality and timely delivery to our customers. Influence the organization to drive transversal improvement programs.

Knowledge

Develop/coordinate and ensure proper training and certifications using innovative learning tools, skill assessments, coordination of a network of experts. Lead benchmarking (internal and external) to ensure GSK is stateofart as required. Develop the group as a reference center within the GIO/Q network for all matters related to SA domains of sterilizing processes. Is the reference for interactions with regulatory bodies (Type-C meeting, regulatory inspections, etc.).

In this role you will

Direction/Guidance: Top Down _
Standardize and establish, rules, standards, processes, targets and guidance for sterility assurance domains of sterilizing processes following QMS guidance
Lead external and internal benchmarking for multiple domains of expertise (sterilizing processes, APS, aseptic holding times and wrapping.)
Set mid/long term vision and strategy for multiple domains of expertise within SA (sterilizing processes, APS, aseptic holding times and wrapping.)
Act as voice of GIO/Q for multiple domains of expertise (internally & externally) on sterilizing processes
Monitor and escalate risks for the implementation of major GIO/Q change programs
Assess and review local proposals for change projects
Collect and analyse KPI (incl. trend analysis) for multiple domains of expertise within SA (sterilizing processes, APS, aseptic holding times and wrapping.)
Support: Bottom Up _
Provide expertise support for major troubleshooting and continuous improvement activity within manufacturing and development as necessary.
Mentor and coach local experts to promote site autonomy in sterility assurance performance
Process _
Develop and animate an expert community for multiple domains of expertise on sterilizing processes, including PSC
Promote knowledge sharing and exchange of expertise across GSK network

Support
development and delivery of training materials for multiple domains of expertise within Sterility Assurance (SA)

Collaborate with other domains of expertise within Sterility Assurance to ensure appropriate objective setting, prioritization, consistency of approach and issue resolution (one voice)
Accountability _

The scope encompasses all sites involved in manufacturing (clinical trials and commercial).

Why you?

Qualifications & Skills:_
Master's degree in Microbiology, Biochemistry, Bioengineering, Pharmacy, Food aseptic production
Minimum 10 years' experience in aseptic or bioburden control manufacturing environment (production, QA, validation) with demonstrated successful results, preferably in FDA regulated environment
Previous experiences leading both local and global projects or strategies is a huge plus
Great communication skills in English and French
Preferred Qualifications & Skills:_
Personal credibility, confidence, and robustness to drive and influence a network of experts
Ability to make persuasive recommendations based on rationale analysis
Able to network internally and externally and to communicate to a wide base of partners
In depth knowledge of regulations, guidance, and industry standards related to sterility assurance (for example: GMP, WHO, PDA, ASTM, ISPE, PhRMA, etc.)
Strong technical and quality skills in sterility assurance issue
Resilience, capacity for adapting in different environment and resistance to pressure
Coaching & mentoring capabilities (competencybased approach)

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 arra