GE HealthCare Material Change Coordination Manager 

Ireland, Cork 

919427422

Material Change Coordination (MCC) Quality Lead Specialist coordinating and ensuring changes to artwork for printed packaging materials (PPM) and product materials are set up, implemented, and maintained in a compliant and timely manner for our GE Healthcare Pharmaceutical Diagnostics (PDx) product portfolio supplied from manufacturing facilities in Cork, Oslo, and Shanghai. This is managed in SAP ERP and current electronic Document Management Systems (eDMS). The position reports to PDx QRA function and will involve extensive contact with various functions and manufacturing sites across the world. Building and maintaining good collaborative relationships with stakeholder groups and working effectively in a virtual environment will therefore be an important part of the role. The process is strictly regulated by Good Manufacturing Practice (GMP), necessitating compliance with regulations and requirements - with the expectation that every action and decision is always with the highest integrity.

Roles and Responsibilities

• Maintain quality operations expertise; ensure quality and regulatory compliance following Good Documentation Practice (GDP) while driving process effectiveness and efficiency.
• Developing in-dept knowledge in how own area integrates with other functions.
• Developing In-dept knowledge of PDx products supplied from Cork, Oslo, and Shanghai manufacturing sites and “where used”.
• Developing In-dept knowledge of correlation between manufacturing processes and components/materials.
• Set up and maintain Stock Keeping Units (SKUs) and related Semi-finished, Packaging materials and Raw materials (Material Master and Master Recipe) on SAP ERP, coordinate implementation at plant level and deactivate at end of product lifecycle.
• Act as coordinator for the artwork change implementation process and effectively be the gatekeeper for each artwork change.
• Analyze request for changes to detect impact, actions, trends or identify potential risks (including but not limited to supply chain risks).
• Developing in-dept knowledge on how to apply and implement Global Product Identification and authentication (barcodes, GS1 standard, etc.) on artwork for PPM.
• Manage Change Controls, Quality Events and CAPAs in current Quality Management System (QMS).
• Ensure standard work and compliance through development of simple yet comprehensive procedures, work instructions, flowcharts, forms, templates, checklists, worksheets, and other product and process related QMS documentation.
• Uses experience and acquired expertise to execute functional policy/strategy according to standard practices and precedents.
• Communicate with colleagues/explain complex information and guide new team members.
• Apply LEAN mindset to drive Continuous Improvement.
• Other relevant tasks based on the person's qualifications and experience, and current needs within function.

Required Qualifications and Experience

• Bachelor’s degree level or equivalent experience from relevant industry.
• Familiar with Quality Management System (ISO, GMP, etc.).
• Familiar with SAP or equivalent ERP system and other electronic Document Management Systems (e.g., Veeva Vault).
• Excellent computer skills M365/Office.
• Fluent in Norwegian and English, orally and in writing.
• Experience from pharmaceutical industry and Good Manufacturing Practice (GMP).
• Experience with Standard Operating Procedures (SOP) and Work Instructions.
• Experience with Change Control, Deviation handling and CAPA.
• Familiar with Global Product Identification and authentication (barcodes, GS1 standard, etc.).
• Familiar with LEAN Methodology.

Desired Characteristics

• Strong oral and written communication skills.
• Analytical and problem-solving skills, ability to identify risks, analyzing root causes and resolve problems.
• Ability to document, plan, market, and execute projects.
• Established project management skills.
• Detail oriented and accurate.
• Highly organized, accountable, and independent.
• Collaborative working across multiple functions and geographies.
• Ability to learn and embrace new digital solutions quickly.
• Training, ability to provide clear guidance and mentoring.
• Enjoy working in a fast-paced environment.

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.