Quality & Regulatory Intelligence Senior Manager
oRequired Diploma : Bachelor Degree in Life science : Pharmacy, Medical/Veterinary, Biology or Biomedical Sciences
oPreferred Diploma: Master of Science or PhD in Life Sciences : Pharmacy, Medical/Veterinary, Biology or Biomedical Sciences
oRequired Experience :
Previous experience in R&D pharmaceutical or vaccines environment is required.
Knowledge of regulatory and industry worldwide guidelines, especially quality systems and vaccines regulations.
Background in scientific or pharmaceutical industry with at least 6 years of experience, among which 4 years in quality assurance or regulatory compliance, preferably in the R&D environment
Detailed knowledge of change control and risk management is preferable.
Experience in global multicultural and virtual teams is required.
GxP regulations and / or international harmonized standards and industry practices (e.g. ICH) in several of the following areas: GLP (Good Laboratory Practices), GcLP (Good clinical Laboratory Practices), GCP (Good Clinical Practices), GEP (Good Epidemiological Practices), GVP (Good PharmacoVigilance Practices), GMP (Good Manufacturing Practices), GDP (Good Distribution Practices)
Global perspective; cultural sensitivity.
oRequired Language: English fluent
oPreferred Language: French fluent
oThis role will :
Ensure a robust End-to-End management of incoming Quality & Regulatory Intelligence Vx R&D wide with an effective triage mechanism with appropriate tools & systems
Support to QRI driven compliance initiatives in R&D so that they are conducted to highest quality standards;
Establish a long term strategic plan for a sustainable handling of QRI intelligence across Vaccines R&D in accordance with well-defined key success criteria.
- Perform screening, monitoring, progress tracking and triage of incoming external QRI which may impact the manufacture & control of vaccines throughout the R&D life-cycle in a time-efficient manner from various external databases.
- Perform an advisory role on review of new/updated/draft QRI potentially impacting Vaccines R&D operations (from discovery research, pre-clinical, technical to clinical, safety and submission authorization to life cycle management) within broad range of GxP area's and internationally recognized quality standards.. Ability to perform and Independent and critical review of QRI.
- Contribute to strategies/quality programs to optimize QRI management and to the roll-out of a cross-transversal improvements project to enhance harmonization in implementation of QRI. Lead activities driving to a consistent, uniform and effective approach to QRI management. Support to development of a new IT system/architecture for database/ dashboard/ tracking QRI system and ensure maintenance once launched.
- Interact within a matrix team involved and embed a strong network/matrix environment with R&D / Q4 R&D partners. Gain alignment and enhance cross-functional collaboration by being a central point of contact for QRI across various functions/stakeholders involved.
- Collect, assess information to improve transversal risk related to QRI management in close collaboration with R&D partners. Ensure continuous improvement and facilitate the deployment of robust remediation activities.
- Manage project and is able to define appropriate progress oversight mechanisms
- Participate as quality partner to initiatives related to updates to R&D written standards owned by the business and assure that the content of R&D written standards meets the regulatory expectations, industry best practices and to Quality Management System Requirements
- Liaise with advocacy practitioner networks internal and external to R&D. Create learning environment for QRI management; enable a knowledge transfer and capability building. Drive and develop 'lessons learned' and associated internal communication. Prepare analysis and build up trends to support to inform management.
- Contribute to QRI topic related discussions in R&D Platforms Quality Councils and quality governance in Q4R&D including preparations/follow-up of the Council and consolidation of quality metrics
- Collect data, set up reports/dashboard (KPIs, KQI, ...), to measure effectiveness of the QRI process and monitor the business readiness on a changing quality & regulatory context.
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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