Leading Quality

4 days ago

The Municipal District of Ashbourne, Ireland beBeeQualityLeader Full time €80,000 - €110,000
Job Title

A quality leader is sought to oversee the introduction of new products and manage large-scale projects within a regulated environment.

The ideal candidate will have experience in New Product Introduction (NPI) and quality governance, as well as sound working knowledge of cGMP. They will be able to communicate effectively with customers and stakeholders, and possess strong leadership skills.

Key Responsibilities
  • Ensure compliance with regulatory requirements and industry standards.
  • Partner closely with customers and stakeholders to understand and deliver on all records within timelines.
  • Participate in cross-functional teams to provide consultative support on quality-related issues and documentation management.
  • Manage operational instructional documentation to ensure it is up-to-date, compliant, and supports efficient production.
  • Act as the main point of contact for all quality escalations from customers.
  • Ensure products and devices are packaged and controlled to meet safety, quality, and GMP standards.
  • Communicate regularly and effectively with cross-functional teams to ensure communication within the business is up-to-date.
  • Work closely with program managers and cross-functional teams to define program strategy, scope, and objectives.
  • Manage project timelines to ensure quality elements are delivered on time and critical paths are identified and monitored throughout their lifecycle.
Requirements
  • Demonstrable experience in NPI and quality governance.
  • Sound working knowledge of cGMP.
  • Experience of working directly with customers as the single point of contact.
  • Strong insight into pharmaceutical customer requirements relating to speed to market, NPI, and service.
  • Industry knowledge of EU GMP and ISO requirements for Medical Devices.
  • 5 years' experience in a quality pharmaceutical or medical device role.
  • Educated to EQF level 6 in a technical, engineering, or science subject.
Benefits
  • Opportunity to work in a dynamic and growing company.
  • Chance to develop skills and expertise in quality management.
  • Collaborative and supportive team environment.
Others

This is an equal opportunity employer committed to equity and inclusion. We strive to create a workplace where everyone can belong and grow.

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