Data Integrity Principle
This job function has accountability for complying with the applicable elements of the Global Quality Framework and the Division Quality Management System (QMS).
Responsibilities and Duties:
- Acts as the point of contact providing regulatory compliance and quality guidance and expertise related to the scope of the Data Integrity practices, standards and tools.
- Be fully responsible for the implementation, oversight and improvement of Data Integrity practices including dependencies with Production and Process Control, Design Control, Supplier Management, Distribution Control, Risk Management, Computer System Validation, CAPA/Non-Conformance, Quality & Supplier Audits, Packaging & Labelling Control, and others, as appropriate.
- Provides Data Integrity guidance and direction to the business units in the development, implementation, maintenance and improvement of the Quality Management Systems; communicates the importance of an effective and compliant Quality Management System w.r.t. DI to all employees and assesses and reports on effectiveness to program management.
- Responsible for training or overseeing training of all staff relative to applicable Quality Management System requirements of Data Integrity practices and tools. Ensures Quality and Regulatory personnel’s professional development through interactions (e.g. on the job learning) and formalized training of DI practices.
- trainer, independent worker, excellent delegation ability, managerial courage and conviction, interpersonal savviness, able to manage vision and purpose, flexibility in approach, ability to work with cross-functional and cross-cultural teams, composure under pressure and able to build effective teams.
- Minimum Bachelor’s degree in Science, Engineering or Medicine with a minimum of 10 years medical device industry experience, particularly within in vitro diagnostics or other related regulatory affairs environment. Experience with Data Quality, Risk Management and Privacy Practices.
- Practical knowledge leadership with well-developed interpersonal, communication skills; management and motivation experience of groups or indirect teams.
- Extensive knowledge of Quality Systems, including successful interactions with regulatory bodies.
- Must have a strategic perspective and be capable of synthesizing information and applying prior experience from multiple sources to build efficient and successful DI compliance and quality strategies for the organization.
- Must be able to work effectively in a cross-functional environment, achieving regulatory compliance though teamwork, facilitation and influence.
- Must have demonstrated written and verbal presentation skills, including ability to articulate complex concepts with clarity. Must have advanced proficiency in MS PowerPoint and Excel.
- Must be well organized and attentive to detail, approaches tasks in a rational manner and capable of providing support and direction to others.
- Must have prior practical program/project management experience.
To apply for this position please contact Chloe Walsh at Sigmar Recruitment T: +353 91 455305 E: firstname.lastname@example.org
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