QC Quality Manager (Deviation)

작업 내용

Site Name: Belgium-Wavre

Posted Date: Oct 21 2021

We are currently looking for a QC Quality Manager Deviation to join our Quality Control Department.

Key Responsibilities

• You are responsible for the effectiveness of the Quality processes, e.g. deviations, CAPA, eCC, Doc & Training, Learning, Data integrity, Digitalization, Audit & Inspection and Compendiale vigilance (lean and efficient)
• You are co-responsible with the Head for the progressive improvment of Quality pillars through adequate Deep Dive, analysis and improvement proposals
• You 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, Digitalization, Audit & Inspection and Compendiale vigilance.
• You escalade risks, problems, proposing action plans to Leadership Management Team for decisions regarding Quality matters
• You 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
• You evaluate applicability of best practices within the MPU/SPU and provide pro-active feedback for their implementation and use
• You are the local operational expert of the Quality process and act as a coach for “deviation fronter” during inspections
• You actively contribute to driving cultural change, building up of capabilities and continuous improvement within the MPU/SPU
• You 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 Deviation (Transversal position within MPU/SPU)

• You are one of the QC DCC (Dev & Capa champions) and actively participate to a transversal community of deviation champions – Represent the QC voice and challenge proposals that mainly impact QC
• You train & mentor on the job (cfr 70% on the job development of the GSK leadership development framework) the new employees or new persons in the deviation role or any person in this role, initiator, Manager, QA
• You evaluate the performance management and deviation efficiency, make results visible through KPI’s
• You ensure the use and application of deviation best practices and guarantee the continuous improvement on deviation management, communicate on deviation quality process
• You evaluate the content of deviations using the assessment grid and apply consequent actions for disqualification (START methodology)
• You support for specific deviation management approach (e.g. Human errors, complex investigation…) and take the lead for the deviations linked to the Dev System
• You assure back up through the team (more specifically for Capas / DCC role and DI aspects)
• You understand and apply RCA tools, check their use on the shop floor, support users
• You ensure use and application of the RCA approach for all complex and multi-department deviations
• You guarantee the RCA expertise transfer efficiently through adequate training, mentoring & coaching activities
• You analyze and identify the individual competences of anyone involved in the use of RCA tool and support them for development needs
• You train all new persons to RCA tools in collaboration with the MPU/SPU DCC community
  

Why you?

Basic Qualifications

• 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
• Key user of the system you are in charge of (Deviation)
• 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

• 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
• Li-GSK
  

Why GSK?

Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork in a culture of Innovation, Performance and Trust.

GSK Vaccines – Our Vaccines business is one of the largest in the world, developing, producing and distributing over 2.5 million vaccines every day to people across 170 countries. For further information, please visit www.gsk.com.

Quality Belgiummanages all product quality related activities in industrial operations in Belgium, including regulatory compliance. The scope covers any action that potentially impacts final product quality. Quality Belgium is also responsible for the quality control and the release of final products made in Belgium.

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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