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Quality Leader (Packaging)

  • GE Healthcare
  • Experienced
  • Posted 2/15/2018 5:51:35 AM
  • 3011582
  • Job Function: Quality
  • Business Segment: Healthcare Quality
Location(s): Ireland; Cork

About Us:
GE is the world’s Digital Industrial Company, transforming industry with software-defined machines and solutions that are connected, responsive and predictive. Through our people, leadership development, services, technology and scale, GE delivers better outcomes for global customers by speaking the language of industry.

It is not about your career… it is not about your job title… it is about who you are…. It is about the impact you are going to make on the world. You want to go into uncharted waters… do things that haven’t been done to make yours and someone else's life better. GE has been doing that for decades! We will continue to do so! We are the world’s digital industrial company.

GE Healthcare provides transformational medical technologies and services to meet the demand for increased access, enhanced quality and more affordable healthcare around the world. GE works on things that matter - great people and technologies taking on tough challenges. From medical imaging, software & IT, patient monitoring and diagnostics to drug discovery, biopharmaceutical manufacturing technologies and performance improvement solutions, GE Healthcare helps medical professionals deliver great healthcare to their patients.

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Learn More About GE Healthcare

GE is committed to taking on the world’s toughest challenges. In order to fulfill that promise we rely on a culture of leadership, diversity and inclusiveness. We aim to employ the world’s brightest minds to help us create a limitless source of ideas and opportunities. We believe in hiring talented people of varied backgrounds, experiences and styles…people like you!

Role Summary:
GE Healthcare Ireland Ltd. manufactures and distributes X-ray and MRI Contrast Media for internal and external customers worldwide. In 2016, our production volume was ca 27.7 mill units (vials) and supported turnover across the Supply chain of ~USD 500M. As part of our ongoing journey to achieve our 2020 site vision of being a 50m unit (vials) capacity site we have created this new role to drive the necessary cultural and operational transformations and simplifications to make this happen.

Essential Responsibilities:
The QA Manager (Packaging) is responsible for managing and providing leadership to the QA Packaging team of QP’s, QA Specialists and QA analysts, as well as liaising closely with the Packaging Manager in the Cork Site to deliver the customer and business needs in a compliant manner that enhances the direct relationship culture. The QA Manager (Packaging) will engage with the relevant support departments and build strong relationships with same.

You will demonstrate Role Model Leadership by facilitating, coaching, mentoring and developing your team. You will deliver EHS performance in accordance with the requirements of the company’s 5S, safety and environmental management programs.

Reporting lines:

The QA Manager (Packaging) reports to the Director of Quality Operations.

Key responsibilities/essential functions include:

  • To coordinate all QA duties relating to packaging batch release and communicate all issues relating to batch release schedule in a timely manner.
  • To schedule, manage and deliver the batch release schedule in compliance with Regulatory requirements and GMP guidelines.
  • Ensure that all necessary production and quality control documentation has been completed and endorsed by authorized staff
  • Maintain oversight of deviations and change controls within the packaging business unit
  • Pro actively lead the packaging QMR process to ensure that the quality system continues to function effectively and that improvement/remediation actions are taken as required
  • Continuous improvement of the quality systems - Identifying and building in efficiencies as necessary from a systematic and compliance perspective
  • Coordinate support for operations in general troubleshooting and problem solving, providing technical direction and guidance to support overall business
  • As part of the QA Management Team responsible for driving the Quality goals in support of the overall business objectives
  • Maintain up-to-date knowledge of pharmaceutical legislation and industry best practice
  • Achieve key project deliverables on time and in budget and support Ad Hoc projects as and when required.
  • Develop and maintain critical relationships with support departments to both develop the role and to enable the growth of the site.

Leadership Behaviours

  • Ability to create and maintain effective interpersonal relationships with all levels of personnel within all cross functional departments in the organisation
  • Excellent communication and negotiation skills promoting openness, dialogue and collaboration
  • Results orientated with a strong ability to effectively troubleshoot and problem solve issues
  • Exceptional planning skills to consistently deliver stretch targets and objectives
  • Act as a change agent to promote a culture of continuous improvement

  • Proven Years’ experience within a regulated environment.
  • 3rd level qualification in Science / Engineering discipline or equivalent knowledge & experience
  • Eligibility to act as a Qualified Person in line with local and EU directives, an advantage, but not necesary
  • Self-starter with good motivational, decision making, planning, project management and communication skills.
  • Good level of knowledge of safety regulations, manufacturing and process automation.
  • Excellent interpersonal skills with the ability to work effectively with staff at all levels across multiple functions of the organization.
  • Experience in developing strong working relationships across teams and functions.

Locations: Ireland; Cork

GE offers a great work environment, professional development, challenging careers, and competitive compensation.  GE is an Equal Opportunity Employer.  Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

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