QA MPU Head

Several major projects are on-going to revamp our MPU facilities and to robust the manufacturing processes and improve the sterility assurance. Plans are being established to increase the capacity of manufacturing to meet the increased market demand, and projects are on-going to supply the US market with our products in the future.

Your responsibilities:

• You establish, manage and assure implementation of quality strategies and programs to enable and support the GSK Vaccines business of the MPU in scope following applicable regulatory, quality, safety and ethical requirements as defined by GSK Vaccines internal policies and procedures and respective national and international regulations and laws.
• Develop and operate Quality activities relating to MPU in scope (Operations, Technical Services, Validation, Governance, Release, Trends, Compliance, Data Integrity, and Sterility Assurance) as part of the Vaccines network of GSK through the application of key business and GMP processes in line with the strategies, policies and standards of GSK Vaccines.
• Achieve quality performance targets, regulatory compliance and cost efficiency for the MPU.
• Act with colleagues on the Manufacturing Quality Assurance Management Team to ensure the continuous supply of vaccines in line with GSK business objectives to meet customer needs and to assure the right level of alignment within the Belgium site.
• Responsible for all release activities related to each product manufactured in MPU providing to the QP the associated release certificate for following steps.

• Responsible for the leadership and operational quality management of the MPU Operations consisting of:

• Multi product facility
• cGMP activities
• Sterility assurance
• Quality systems
• Compliance and audit
• Validation
• Technology Transfer between sites
• Commissioning, Qualification and Operationalization of new investment for significant projects

• Responsible as a member of the MPU leadership team of the PSQDC (People, Safety, Quality, Delivery, Cost) day to day management & results of the MPU

Basic Qualifications:

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

• University degree (M.Sc., M.Eng., MBA, PhD) in area of Science, Engineering (business with science)

Preferred Qualifications:

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

• Minimum 10 years of experience, in a pharmaceutical/sterile operations /biological production environment and min of 5 in QA.
• Excellent knowledge of FDA/EU/ICH/CDN/AUS guidelines and inspections.
• Strong knowledge of GMP.
• Executive and leadership capability to manage people.
• French speaker with excellent written and spoken English skills.
• Strong Interpersonal skills and developed knowledge of data integrity.

• 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.

Global Quality Departments is responsible for setting up all global rules and regulations to ensure GSK vaccine products are manufactured, tested, released and distributed in compliance with regulatory requirements.

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.

Quality for Research & Development in partnership with R&D teams promotes quality and enables them ensuring activities of Research & Development are delivered in a compliant and sustainable way, in order to guarantee patient safety, company and regulators satisfaction, as well as successful product pipeline delivery.

At GSK we value diversity and treat all candidates equally. We aim to create an inclusive workplace where all employees feel engaged, supportive of one another, and know their work makes an important contribution.

We provide a supportive working environment, and a range of development challenges and opportunities. We also offer competitive benefits and compensation packages designed to attract and to retain the very best.

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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