Qc Quality Manager Data Integrity

il y a 2 semaines

Wavre, Belgique GSK Temps plein

**Site Name**: Belgium-Wavre

**Posted Date**: Aug 7 2023

In this role you will
- Be responsible for the effectiveness of the Quality processes (lean and efficient)
- Co-responsible with the Head for the progressive improvment of Quality pillars through adequate Deep Dive, analysis and improvement proposals
- Ensure adequate Key Performance Indicators and processes ( i.e. tier meeting, deviation review board,) are in place and in use in all the QC department to monitor, track, and drive progress with respect to i.e. deviations, CAPA, eCC, Doc & Training, Learning, Data integrity, Audit & Inspection and Compendiale vigilance.
- Escalade risks, problems, proposing action plans to Leadership Management Team for decisions regarding Quality matters.
- Analyze, lead and coordinate coaching or mentoring based on individuals’/ team needs and business requirements, i.e. new standards, transversal procedure, etc. linked to Quality
- Evaluate applicability of best practices within the MPU/SPU and provide pro-active feedback for their implementation and use
- Be the local operational expert of the Quality process and act as a coach
- Actively contribute to driving cultural change, building up of capabilities and continuous improvement within the MPU/SPU
- Actively benchmark local practices (not included in Best Practices package) with other MPU/SPU & QA organization ), activate the network to anticipate changes/trends)

Additional specific to this role:

- Responsible for Data integrity (Transversal position within QC)
- Be the QC DI LSPOC and actively participate to the transversal DI community - Represent the QC voice, propose simplification and improvement and challenge proposals that mainly impact QC
- Train & mentor on the job (cfr 70% on the job development of the GSK leadership development framework) the new employees or new persons on the data integrity aspects to increase maturity through QC
- Evaluate the performance management of data integrity, make results visible through KPI’s and periodic report, share the results in i.e. QC monthly quality council, drive the QC DI community and propose improvement
- Support for specific DI deviation management approach (e.g. complex investigation )
- Train all new persons to RCA tools in collaboration with the MPU/SPU DCC community
- Give DI support in the Digitalization projects

**_ This job opportunity is a permanent contract _**_not_**_ opened for relocation._**

**_ Why you? _**
- Qualifications & Skills:_
- Master’s degree in Engineering and scientific in biotechnology
- Interaction with a wide range of stakeholders on a transversal level.
- Min 5 to 10 years of relevant experience
- Good understanding and knowledge of regulatory guidance and cGMP/GQP/GQMP
- Good knowledge of the Data Integrity (DI) principle on all the Quality aspects
- Good knowledge in English and fluent in French
- Strong interpersonal and people management skills with demonstrated engaging, empowering and decisive leadership style

Preferred Qualifications:

- Demonstrated ability to quickly understand end to end process
- Sense of urgency, flexibility and accountability Enterprise thinking (end-to-end supply orientation, cross functional team spirit, sharing of good practices within the network)
- Strong quality and results oriented mindset
- Maintain a high level of integrity while balancing multiple priorities and responsibilities
- Ability to lead and drive change
- Demonstrated ability to take full accountability of small or medium project
- Li-GSK

GSKTechTalent

**_ 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 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 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.

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

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