Basic qualifications: 

•Bachelor’s Degree + practical experience in aseptic manufacturing or quality role (10 years)
•Microbiology, bio-engineering, pharmacy, biology, food industry
•Complexity and specificity of aseptic vaccine manufacturing
Post-graduate degree (Master, PhD, DSc…) + practical experience  in aseptic manufacturing or quality role
Microbiology, bio-engineering, pharmacy, biology
Strong and demonstrated experience in aseptic manufacturing is a must.
Experience in quality assurance, quality control (microbiology), engineering, regulatory inspection, project support is preferred.
Credibility. Complexity and specificity of integration of aseptic aspects in vaccine manufacturing

Preferred qualifications: 

See Basic Qualifications

Details: 

Our Company:

GSK is a science-led global healthcare company that researches and develops a broad range of innovative products in three primary areas of Pharmaceuticals, Vaccines and Consumer Healthcare.
We have a significant global presence with commercial operations in more than 150 countries, a network of 86 manufacturing sites in 36 countries and large R&D centres in the UK, USA, Spain, Belgium and China.
Research is vitally important to the success of our business, and we spent just £3.4 billion in 2013 in our search to develop new medicines, vaccines and innovative consumer products. We are one of the few healthcare companies researching medicines and vaccines for the World Health Organization’s three priority diseases - HIV/AIDS, tuberculosis and malaria.
Our Vaccines business is one of the largest in the world, producing paediatric and adult vaccines against a range of infectious diseases. In 2013, we distributed more than 860 million doses to 170 countries, of which over 80% were supplied to developing countries.
At GSK Vaccines, we employ over 12,000 people worldwide, including more than 8,000 at our global headquarters in Belgium. Almost a quarter of our staff work in research and clinical development, inventing new and innovative vaccines against some of the world’s most serious infections and diseases.  
For more information please visit www.gsk.com


The department:

Global Quality Assurance 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.
QA Belgium manages all product quality related activities in industrial operations in Belgium, including regulatory compliance. The scope covers any action that potentially impacts final product quality. QA Belgium is responsible for the release of final products made in Belgium and at international sites.
Applicants should have a master’s degree in science or engineering. Experience in the pharmaceutical or biotechnology area is an asset. GSK will give you the opportunity to develop strong organisational skills in a challenging and complex project-driven environment.

Job purpose:
•Benchmark bio and GMS sites to review best practice. To take part in conferences and workshops, to benchmark industry standards, build an external network
•Define global strategy for aseptic and EM practices e.g. EM locations, gowning, viable and non-viable monitoring program, material transfer, Grade A cont. capping, human behaviour, etc.
•Act as a reference for world class expertise in aseptic matters.
•Coaching global sites: Singapore, China, Belgium, France ,USA ,Canada
•Provide specialist support for major aseptic issues e.g. Contamination in Grade A/B areas, hidden surfaces, unusual aseptic issues, Media fill failures.
•Run aseptic transversal projects in the global GSK Bio sites network
•Global SME for aseptic and EM processes e.g. writing bio guidelines, defend global aseptic and EM issues in audits.
•Provide expertise regarding facility design and WOW for aseptic processes to senior management, Local QA, QC, GTS, GIO.
•Work/interact/partnership with GMS to standardize, harmonise and improve quality documents e.g. GQMPs
•Active member of the global GSK Biologicals community of practice e.g. discussion of technical aseptic issues, presentation of new concepts / improvements.
•Interpretation of regulatory documentation when they are updated.

Our Offer: 

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.

Apply here: http://www.jobsinbrussels.com/ads-GSK-Bio-Senior-Manager-Quality-Assurance-66931.aspx