Manager Sterility Assurance Performance
- Master degree in Sciences or equivalent experience
- At least 5 years of professional experience in the pharmaceutical environment on site manufacturing sterile drugs or vaccines. An experience of min. 2 years in production is a must.
- Successful experience as change leader in complex environment – strong influencing skills
- Successful experience of network animation in complex environment - Very good communication skills with various people (from shopfloor people up to site management – including quality and production)
- Broad experience in sterility assurance and GxPs
- Lean and 6 sigma knowledge si an advantage
- Strong analytical skills
- Good Interpersonal skills with demonstrated engaging and decisive leadership style and well developed relation building skills to gain trust and credibility
- Very good knowledge of cGMP for biological products
- Ability to make a good balance between GMP requirements and manufacturing reality
- Strong analytical and problem solving (trouble shooting) skills and flexible thinking capability
- Continuous improvement focus – ability to challenge the status quo
- Effective communication skills, good level of written and spoken French (mother language) and English
- Effective influencing skills – ability to influence at all levels of management
- Training and mentoring skills
- Strong quality and results oriented mindset
Job purpose :
- Measures, analyses, monitors & report on site Sterility Assurance (S.A.) Performance – organizes central oversight on S.A. Performance – tracks related action plans
- Animates the corresponding network (i.e. community of MPU S.A. Performance managers + their compliance authority (SAMs)). Promotes best practices & sharing inter-MPUs.
- Coordinates the definition of Site & MPU S.A. performance indicators. Ensures the in use status of those indicators. Proposes transversal action plans based on the output of the analysis.
- Manages S.A. risks & escalation process – is the link with the MPUs
- Coordinates evaluation of S.A. transversal SOPs feasibility (changes & current SOPs). Facilitates the implementation & changes of the transversal S.A. SOPs & CAPAs
Key responsabilities :
- Sterility Assurance :
- Anlayses site S.A. performance on a Monthly & quarterly basis, based on the indicators defined & endorsed by the site
- Reports to the site & vaccine S.A. Governance (SAG Peformance & VPQB)
- Follows & challenges MPU – SPUs on action plans & CAPAS roll-out & effectiveness
- Supports MPUs through Gembas, PSS, deep dives. Interfaces with the vaccine, site & local experts – proposes transversal action plans
Network animation :
- Organises & animates the monthly TIERs with S.A. Perfomance managers & SAMs : preparation, challenge on results, roll-out action plans, escalations, communications, sharings, etc.
- Is the link between the MPUs-SPUs and the S.A. transversal & global functions (site & global SMEs)
- To be the voice of the site for S.A Performance; for intra or inter-sites meetings
S.A. Risks management & escalation :
- Manages & inputs the S.A. Risk Register
In use status of the S.A. transversal SOPs :
- Proposes pragmatic solutions to implement new S.A. rules. Uses the network to achieve this (Gembas, PSS, deep dives, deep dives, workshops, etc.)
- Uses the network to identify implementation problems, in order to propose mitigation actions
- Quality / Regulatory / EHS :
- Ensures compliance to local and international standards, cGMP, Regulatory requirements and all GSK Quality Management Systems (QMS) policies and procedures as applicable as well as adherence to the Environmental, Health and Safety rules.
- People & Organization:
- No team to manage
- Financial :
- No budget to manage
- Change and continuous improvement & Knowledge:
- Provides quality environment and leadership for change initiatives in the area of expertise which contribute to the overall effective improvement of GSK Vaccines manufacturing and supply
- Shares and integrates best practices within the GSK Quality, GSK Vaccines and wider GSK Network
- Represents quality during external regulatory audits in specific area of responsibility as required
- Replies to auditors requests during inspections and supports the manufacturing operations during GMP inspections
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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