Quality Systems Principal
Job ID: JOB-11458
Quality Systems Principal
A leading medical device company in Galway is looking to hire a Quality Systems Principal to join their team on a permanent basis.
This role is responsible for supporting the Data Integrity (DI) activities, primarily through the division and entities, in accordance with the ALCOA+ requirements.
Responsibilities include identifying, evaluating, protecting against and reporting on data integrity risks and enacting mitigation actions. The Principal shall be a subject matter leader with a regulatory compliance background and a detailed working knowledge of data quality standards (e.g. ISO 25012, ISO 25024), practices, policies, and their application in a global medical device market.
The role will proactively work with Quality, Regulatory, R&D and IT Leaders and business units to implement techniques that meet defined policies and processes for data integrity practices.
Key activities include risk management (evaluation, control, risk/benefit analysis, residual risk acceptability and reporting), product and enterprise application controls, developing and implementing the applicable policy and process, training, monitoring and metrics of the ALCOA+ requirements. The Principal shall support the risk reduction and mitigation to the products and services to meet compliance and regulatory requirements within the Quality Management Systems.
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.
- Extend the Quality Systems Framework with the scope of Data Integrity. Monitor industry regulatory data integrity trends and evolving practices that impact the Quality Management Systems.
- 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.
- Lead the Data Integrity deployments that aligns with the business unit priorities.
- 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.
- Ensure site and division function procedures are created that adopt and align with the Data Integrity ALCOA+ requirements.
- Collaborates with the teams to create and implement shared processes and metrics, where appropriate. Establish partnerships with IT, Operations, Quality, R&D, Commercial and Regulatory Affairs.
- 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.
- Measure effectiveness of the DI process adoption in the Quality Management System and ensures continuous improvements.
- Responsible for exhibiting professional behavioru with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
- Responsible to understand and maintain awareness of the quality consequences which may occur from the improper performance of their specific job.
- Perform other duties and projects as assigned.
- Key position competencies: Problem solver, effective 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 be able to interpret the guidelines, and to convert these into practical and pragmatic deliverables. Practical knowledge of regulations and standards (e.g. ISO 25012).
- 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.
For further information on this role please contact Clara Burke on 086 816 8273 or firstname.lastname@example.org
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