Site Conformance Manager
- Master Degree or PhD
- Pharmaceutical Sciences, Biology, Chemistry, Bio/Chemical Engineering or any other applicable scientific discipline, as the person will act as accountable of the regulatory oversight of operations, he/she must have a scientific background
o10 years in Pharmaceutical Industry
oExperience in a quality or regulatory compliance role (preferably in an FDA approved context)
- Area of specialization: Knowledge of legislation related to licence acquiring and life cycle
- Knowledge of quality systems
- Capacity to work across boundaries and in cross functional teams
- Communication and influence skills
- Coaching and training skills
- Capacity to present in front of a national and international panel
- Analytical skills
- European cGMPs (Eudralex vol4) define that the purpose of controlling batch release is to ensure that the batch has been manufactured and checked in accordance with the requirements of its marketing authorization.
- The principal duty of the Site Conformance Manager is :
oTo liaise, between the Global Regulatory Affairs organization and several Manufacturing Performance Units or Quality Control Department or incoming Material Department , on regulatory compliance matters,
oTo ensure the regulatory oversight within operational Belgian organization.
- Provide Chemistry/Manufacturing/Controls (CMC) and regulatory expertise within various operational Belgian organization, to ensure continuous alignment of Operations with the approved data by Health Authorities, for different aspects.
- Accountable for:
oProvide leadership and direction to multiple operational Belgian departments on regulatory conformance matters.
oDefine workload priorities for multiple operational Belgian departments.
oCoach and develop regulatory expertise of multiple operational Belgian departments.
- Site support within CMC processes
oEnsure accuracy of documents requested for filing in the time frame required.
oApprove, on behalf of Operations, files submitted to Health Authorities.
oCoordinate Questions & Answers and Commitments.
oProvide technical/site support to Global Regulatory Affairs (GRA) in communication to and from Health Authorities.
- Provide CMC and regulatory conformance expertise to support the release of products (deviation, visibility to registered requirements, implementation strategy,…)
- Change Control
oPerform the initial assessment of the potential regulatory impact of changes.
oLiaise with Global Regulatory Affairs for the definition of the regulatory strategy
oLiaise with Operations for the definition of the implementation and release strategy.
- Be empowered to develop and drive improvements of the regulatory conformance matters in GSK practices.
- Be the Single Point of Contact (SPOC) for any topic related to regulatory compliance to support regulatory conformance on the Belgian Site.
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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