Manager, QA Operations Packaging
- University (Master) degree in Sciences / Biological Engineering (e.g.Pharmacist / Master in Sciences / Bio Engineer)
- At least 3 or 5 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
- Experience with clean or aseptic manufacturing is an asset for certain manufacturing units
- 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 cGMP and guidelines (FDA/EU/WHO)
- Demonstrated impact and influence
- French speaker with good level of written and spoken English
Acts with colleagues of the production team and Primary / Secondary Quality Assurance Team to ensure
the continuous supply of clinical vaccines in line with GSK business objectives to meet customer needs.
Manages operational quality assurance activities in Primary/Secondary NPI ops 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.
Drives and leads the release QA release process in the primary/secondary NPI to ensure a continuous and
effective release of clinical batches (intermediate or finished products produced within the Manufacturing
Performance Unit) in compliance with Good Manufacturing Practices and Regulatory requirements.
Monitors and analyses quality performance targets for the Primary/Secondary NPI and provides trending
Ensures regulatory compliance and audit readiness of the Primary/Secondary NPI 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
Responsible for the leadership of the operational QA within the Primary/Secondary NPI.
The scope of the quality oversight consists of :
- One or several productions lines or production building within NPI Unit
The responsibility covers:
- QA GMP operational activities
Organizes and provides QA oversight for operational and technical services activities related to commercial
vaccines manufactured in an Primary/Secondary NPI
Assures the QA release of batches at each production step in compliance with GMP requirements including
documentation and certificate review
Ensures a continuous Quality and Compliance improvement mindset within the Operations
Environment such as to ensure compliance with cGMP's and GSK Quality Management System.
Ensures Documentation Management within Primary/Secondary NPI is aligned with GSK Vaccines Belgium
Documentation system / SOPs and performs compliance check as well as alignment with method of
production, process validation and regulatory files prior to procedure approval ; ensures Primary/Secondary
NPI master production documentation is in line with validation and regulatory files prior to QA Operation
Approves Primary/Secondary NPI specific GMP training packages for QA, Production and support staff
within the Primary/Secondary NPI and ensures QA staff are adequately trained/certified and coach QA
team through presence on the shop floor
Approves specific Primary/Secondary NPI compliance and quality risks and follows up risk register actions
Timely escalates critical non compliance and compliance/quality risks within Primary/Secondary NPI to
management and manages these risks through the risk register process
Ensures Primary/Secondary NPI regulatory files are adequately reviewed before submisson
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 Primary/Secondary NPI
Acts as a backup of the Primary/Secondary NPI QA Head
At GSK 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. GSK is proud to promote an open culture, encouraging people to be themselves and giving their ideas a chance to flourish. GSK is an equal opportunity employer.
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.
GSK is one of the world's leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.
GSK Vaccines is one of the world's leading vaccine companies, with a comprehensive portfolio of 39 vaccines for infants, adolescents and adults and 15 more in development. We have more than 16,000 people working worldwide to deliver nearly 2 (1.9) million vaccines every day to people in around 90% (172) of the world's countries.
For further information, please visit www.gsk.com.
You may apply for this position online by selecting the Apply now button.
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