Automation Compliance Manager

The role of Automation Compliance Manager is a new role that has been announced as part of the Belgium Automation Transformation.

The mission of the team is to drive the vision of automation across the Belgium sites, by leading the definition, implementation and application of Automation Strategy. The team provide dedicated expertise to support to automation operations & deliver transversal projects for Wavre, Rixensart and Gembloux to ensure that all systems, equipment and facilities are properly maintained, safe, reliable and compliant with GAMP.

The role is support the operational and transversal automation teams in all the Safety & Quality compliance aspects of their activities. You will be accountable to apply best practices to manage deviation, capa, change control, training, master data and admin task for all automation. You will set up and manage the governance for those subjects across automation. You will be in charge to develop your team capabilities to install efficient performance management system.

Your responsibilities:

• You will ensure the full responsibility of the team (6 to 15 people including externals). This includes people selection, coaching, personnel training to the required competencies, contacts with social partners, as well as all daily aspects of a team’s life.
• You will make sure that EHS, cGMP (current Good Manufacturing Practices), GMP procedures and recommendations from the authorities are respected across automation.
• You will be accountable for the management of quality activities in automation: Deviation, CAPA, Change control are properly initiated, executed and closed.
• You will be responsible for the implementation of a continuous improvement system around Training Management to ensure training is continuously adapted to automation activities.
• You will be responsible for the implementation of a continuous improvement system around Master data Management to ensure that Master Data is continuously adapted to automation activities.
• You will be accountable for leading, driving, participating and reviewing deviation investigations and back up of the compliance coordinator in his/her team, including Deviation Manager role.
• You will participate to Quality meetings for REEX, activity strategy
• You will participate in the development and maintenance of performance metrics to drive continuous Improvement
• You will facilitate the development of governance to ensure that automation activities are performed consistently in a safe, compliant and efficient manner
• Preparation and representation for automation in regulatory and customer audits. Fronter during inspection, coordinate answers.
• You will be managing automation compliance methodologies, strategies, systems and standards including Data Integrity, SOP periodic review and other documentation.
• You will assist leadership team with strategy, methodologies and documentation of process and procedures from a compliance perspective.

Basic Qualifications:

• About 5 years of management

• Master in management sciences or similar study

• Strong networking, influencing and negotiation skills to engage a broad community of multi-departmental stakeholders.
• Ability to handle multiple issues and effectively prioritize
• Exposure to FDA regulated environments including validation experience
• Fluent in French and English

Preferred qualifications:

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

• Capacity to make independent sound decisions and independently manage priorities
• Positive, Autonomous & solution-oriented
• Manage complexity and deliver long term benefits for the company
• Decision-making abilities

• Li-GSK

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.

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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