QC Quality Manager Audit & Compendial Vigilance

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Site Name: Belgium-Wavre

Posted Date: May 24 2022

As QC quality manager Audit and Compendial vigilance you ensure the quality processes are effectively and efficiently deployed and managed for the Be QC (Belgium Quality Control) so that high quality level practices relative to the processes are in place and in use and affect positively the business performance.

You support the business strategy and Operational Be QC objectives by improving process efficiency within the department through the deployment of quality programs, Continuous improvement initiatives, Program Management and Learning.

Key Responsibilities

• Responsible for the effectiveness of the Quality processes (lean and efficient)
• Co-responsible with the Head for the progressive improvement of Quality pillars through adequate Deep Dive, analysis and improvement proposals
• Ensure adequate Key Performance Indicators and processes ( i.e. tier meeting, …) are in place and in use in all the QC department to monitor, track, and drive progress with respect to i.e. CAPA from Audit, Audit & Inspection and Compendial 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 (Manufacturing Performance Unit) and provide pro-active feedback for their implementation and use
• Be the local operational expert of the Quality process (Audit & inspection, compendial vigilance)
• 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

• Guarantee a pro-active auto-inspection/internal audit culture, inspection readiness and follow up of compendial vigilance for QC.
• Prepare, organize and coordinate QC BE internal inspections and inspections from authorities (including answering process)
• Prepare and follow-up of L1 inspection schedule (univers, planning), monitor and continuously improve the performance of self-inspection process
• Perform self-inspection
• Lead and apply the inspection readiness program for Be QC
• Coordinate and follow up the assessments in case of compendial changes
  

Why you?

Basic Qualifications

We are looking for professionals with these required skills to achieve our goals:

• Master degree in a scientific discipline with min 5 to 10 years of relevant experience
• Good understanding and knowledge of regulatory guidance and cGMP/GQP/GQMP
• Good knowledge of the DI (data integrity) principle on all the Quality aspects
• Able to interact with scientist and managers.
• Able to turn theoretical learning into practical tools.
• Good knowledge in English and fluent in French
• Strong interpersonal and people management skills with demonstrated engaging, empowering and decisive leadership style
• Well developed relation building skills to gain trust and credibility and to build a great place to work and good social climate within cross functional teams
• Excellent team builder / team player
• Customer oriented: ability to active listening to internal customers and pro-actively proposing solutions based on their needs
• Creative approach to problem solving and the ability to challenge the status quo
• Effective communication skills (communication with different stakeholder) , including training / animation / presentation skills
• Effective influencing skills – ability to influence at all levels of management and to energize a team towards to pursue common goals
• 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
  

Preferred Qualifications

If you have the following characteristics, it would be a plus:

• Demonstrated ability to quickly understand end to end process
• Demonstrated ability to take full accountability of small or medium project
• Good analytical and problem-solving skills
  

Why GSK?

At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Healthcare, strengthening our leadership, and transforming our commercial execution. Now, we’re making the most significant changes we’ve made to our business in over 20 years. We’re on track to separate and create two new companies in 2022:New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands.

With new ambition comes new purpose. For New GSK, this is to unite science, talent, and technology to get ahead of disease together – all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive.

Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients– so we deliver what matters better and faster; accountable for impact– with clear ownership of goals and support to succeed; and where we do the right thing. So, if you’re ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together.

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.

Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.

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