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| Senior Audit Manager, GCP Quality Assurance |
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Merck Serono is the division for innovative small molecules and biopharmaceuticals of Merck KGaA. Its Headquarters in Geneva, consist mostly of Research, Clinical, Marketing, Support Functions and the Divisional Management.
PURPOSE OF ROLE
Responsible for the management, conduct and follow-up of Clinical Development audits, as assigned, including vendor management in the framework of trials sponsored by Research & Development.
Provides to relevant functions, all appropriate audit elements and expertise to ensure continuous quality improvement of the Global R&D activities.
Supports the Head of the audit function in managerial tasks and strategic responsibilities within R&D QA and acts as deputy in his/her absence.
Interfaces with R&D QA Quality Optimization representatives for the development of quality strategies, provision of training expertise and performance management support.
Supports the preparation and follow-up of regulatory inspection activities.
KEY TASKS & RESPONSIBILITIES
Functional Tasks
Participates in the formulation and implementation of viable, results-oriented development audit strategies and methodologies,
Defines in collaboration with the Head of the audit function the audit strategy applicable to GCP related quality system, in liaison with Corporate QA and functional QA
Defines and implements comprehensive and consistent project and trial specific audit plans applicable to the assigned R&D Departments'activities and GCP-related facilities and tools,
Conducts and ensures appropriate follow-up of project and trial specific audits in concert with responsible DQA staff and Development partners,
Is accountable for reporting to DQA management on the accuracy, quality and integrity of effective Development activities and processes respectively conducted and implemented within assigned R&D Departments,
Supports the preparation of regulatory inspections related to R&D activities, processes or facilities
Independently coordinates external audit services on all audit types, from selection, contracting, surveillance, report review, follow-up of CAPA and evaluation of service.
Provides to the R&D QA Document Management group with audit expertise for the review of quality documents,
Liaises with R&D QA Quality Optimization group by providing support and expertise to the development of quality strategies and the identification/development and implementation of training needs/modules,
Keeps the Head of Global Development Audit Management informed on the status of assigned activities
Provides R&D QA intelligence in terms of audit approaches, methodologies and technical expertise by staying current with trends in industry and benchmarking with other relevant organizations and being active in external professional forums
Managerial Tasks
Lead and motivate employees
Plan and oversee budget and resource demands for their respective department/function/ responsibility area;
Coordinates the training and evaluation of auditors on new audit approaches or new audit standards
Foster an open communication, quality and performance oriented culture |
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Masters degree (scientific area)
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10 years + |
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French : Speak Well
German : Speak Well
English : Speak / Write Fluently
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open-ended |
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unspecified |
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EU National |
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Geneva |
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Life-science degree at a minimum, post-graduate degree in scientific area preferred
Fluent command of spoken and written English; knowledge of other language(s) such as French and/or German an asset
3 - 5 years experience in Good Clinical Practice auditing with in depth knowledge of auditing concepts, approaches and techniques
3 - 5 years in clinical development setting in an international pharmaceutical and/or biotech industry with excellent knowledge of regulatory and business requirements
1 - 3 years Managerial experience
Ability to interpret regulations for the day to day business of drug development
In depth knowledge regulatory requirements applicable to clinical development and GCP guidelines applicable in the ICH regions and awareness of US regulatory requirements |
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Merck Serono is the division for innovative small molecules and biopharmaceuticals of Merck KGaA.
Merck Serono’s global headquarters are located in Geneva, Switzerland. |
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