Manager QA Validation & Projects for Technical Service (MPU New PA)

Job purpose:

You act with colleagues of the production team and Primary / Secondary Quality Assurance Team to ensure the continuous supply of vaccines in line with GSK business objectives to meet customer needs.

You manage operational quality assurance activities in the Manufacturing Performance Unit (MPU) as part of the GSK Vaccines network through the application of key business and GMP processes in line with the strategies, policies and standards of GSK Vaccines.

Monitors and analyses quality performance targets for the MPU

Ensures regulatory compliance and audit readiness of the MPU in collaboration with the QA Release, Trending and Compliance manager

Responsible to implement and monitor the GSK Vaccines quality strategy within the operations of the MPU.

Responsible for the leadership of the operational QA within the MPU.

The scope of the quality oversight consists of :

• One or several productions lines or production building within the Manufacturing Performance Unit
• The responsibility covers:

QA GMP operational activities

QA Technical Services related to Maintenance, Calibration and Measurement, …

QA Validation (for operational aspect

Your responsibilities:

• Organize and provides QA oversight for operational and technical services activities related to commercial vaccines manufactured in an Manufacturing Performance Unit (MPU)
• Ensure a continuous Quality and Compliance improvement mindset within the Operations environment such as to ensure compliance with cGMP’s and GSK Quality Management System.
• In collaboration with QA release, ensure continuous release of commercial batches in compliance with Good Manufacturing Practices and regulatory requirements.
• Contributes to regulatory inspection readiness and provide QA expertise to act as a key spokesperson during external Regulatory inspection
• Organizes and takes the Quality Assurance oversight for new projects (facilities – utilities – equipment – processes) in the MPU

Acts as a backup of the MPU QA Head

Quality Assurance

• Ensures adequate QA oversight on all production, maintenance and calibration deviations both in terms of content (root cause and CAPA’s) and timeliness
• Ensures any deviations, CAPA, change control, maintenance and calibration plan are reviewed and handled in accordance with procedures and in a timely manner
• Timely escalates critical deviation and major risks to management
• Ensures adequate QA oversight on all production change controls both in terms of content and timeliness
• Ensures all master production documentation are in line with validation and regulatory files.
• Ensures building, equipment are under validated stage and CVP, VP, QSR, TCD, periodic requalification for his/her MPU are timely approved.
• Acts as a key player in the continuous Quality and Compliance improvement in collaboration with QA compliance manager.
• Prepares and participates to regulatory inspections: be a front line spokesperson for all operational quality related aspects during inspections
• Provides QA expertise to support new project or new product introduction in the MPU.
• Ensures QA representation and decision making in all meeting related to his/her area of responsibility
• Ensures deployment of GMP training to QA and MPU personnel.
• Masters the key QA activities related to production, QC, maintenance, calibration, and validation in his/her area of responsibility

People Management and Development:

• Leads, selects, trains, evaluates, coaches and motivates QA operational team towards the pursuit of operational excellence and attainment of Good Manufacturing Practices
• Manages people through effective performance management and labor relations excellence
• As a leader, personally role models and develops the team towards high performance behaviors
• Ensures succession is in place for key roles in his/her organization to minimize operational risks
• Engages the team to deliver the GSK Vaccines, GIO and Quality strategy

Site Representation:

• Participates to external audit as appropriate

Change and Process Management:

• Implements change initiatives involving processes, technologies and people which contribute to the overall effective improvement of Quality within the MPU
• Applies lean sigma across the teams to ensure continuous improvement

Shares and integrates best practices within the Vaccines Quality Network.

Why you?

Basic Qualifications:

We are looking for professionals with the following required skills to achieve our goals (must-have):

• University (Master) degree in Sciences / Biological Engineering (e.g. Pharmacist / master’s in sciences / Bio Engineer)
• French speaker with good level of written and spoken English
• At least 5 or 8 years of experience in a pharmaceutical / biotech / medical device / food industry or equivalent environment
• Direct experience with GxP regulated environment within major authority jurisdiction (FDA / EU / WHO Audit)
• Successful team leadership experience
• Relevant quality experience, not necessarily within a quality department manufacturing unit
• Substantial knowledge of regulatory, GMP and legal requirements relating to QA needed
• Need to master the key QA activities related to production, QC, maintenance, calibration, and validation in his/her area of responsibility.
• Strong interpersonal and people management skills with demonstrated engaging, empowering and decisive leadership style and well-developed relation building skills to gain trust and credibility and to build a great place to work and good social climate
• Strong knowledge of GMP and guidelines (FDA/EU/WHO)
• Demonstrated impact and influence

Preferred Qualifications:

The following characteristics are assets (nice-to-have):

Experience with clean or aseptic manufacturing is an asset for certain

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.

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.

Our department:

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.

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.

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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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