Manager QC Data Integrity

The QC Manager Data Integrity is responsible for the QC of Data Integrity remediation and sustainability.

• You are responsible for the DI remediation/mitigation: establish and execute plan to close Data Integrity gaps. Through the validation team, deliver validation services including process control validation (writing and reviewing/approval of protocols, execution, management of deviations & CAPAs)

• You are responsible for the coordination of the process control validation of analytical systems

• You develop equipment validation expertise to be recognized as single point of contact for Data Integrity activities

• You support introduction of new technologies and provide security advices to ensure DI requirements are met

• You act as SME (Subject Matter Expert)

• You are responsible for ensuring inspection readiness regarding validation during internal GSK audits and external authorities inspections and to ensure follow-up of commitments.

• You are fronter during audits and inspections

• You ensure compliance with QA within its scope of responsibility.

• You manage and develop a team of 5 people including technicians, coordinators & consultants/contractors.

Basic Qualifications:

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

• University scientific degree or equivalent gained through experience

• Specialistation in Life-Science (Biology, Biochemistry or Chemistry) or specialization of lab equipment (process) validation

• Min 5 years’ experience including experience in leading groups

• Expertise in lab equipment

• Fluent French and good knowledge of English

Preferred Qualifications:

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

• Ability to talk about equipment and functionality in use in Laboratories with a good knowledge of its use and functionality.

• Knowledge in the validation life-cycle process as well as in specific validation strategies (i.e. process control).

• Project management skills and project management experience.

• Ability to drive change

• Good capacity to work in GXP environment.

• Inspection front-liner is an asset.

• Ability to engage, influence and lead people

• Li-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 has a broad portfolio and innovative pipeline of vaccines to protect people of all ages. We deliver over two million vaccine doses per day to people living in over 160 countries.

For further information, please visit www.gsk.com.

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

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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