Quality Operations Process and Compliance Director

at  GE Healthcare

JOB DESCRIPTION SUMMARY

As Quality Operations (QO) Process and Compliance Director you will be responsible for coordination and execution of QO Operating Process Compliance and be the Quality Leader for PDx Strategic and Capacity Expansion Programmes. This role will be a key driver for GE Healthcare’s Quality vision and to execute at a global level across sites and functions quality objectives, metrics and operating mechanisms. You will report directly to the Executive Quality Operations, Pharmaceutical Diagnostics.
In this global role, you will work remote. Candidates for this role are currently based near one of our PDx production sites in Cork, Eindhoven or Oslo.

JOB DESCRIPTION

GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.
GE HealthCare Pharmaceutical Diagnostics (PDx) is the number one global supplier of contrast media and molecular imaging agents used to enhance medical imaging exams. Used throughout all major disease area diagnostic and treatment pathways, PDx products support three patients every second around the world.

BASIC REQUIREMENTS AND QUALIFICATIONS

• Bachelor’s degree and significant business experience in QA roles in the Pharmaceutical or Medical Device industries;
• Demonstrated experience with applying classic Quality tools
• Experience interfacing global regulatory agencies and governmental regulators;
• Demonstrated ability to lead teams across poles, cultures or sites;
• Ability to detect trends or shifts in requirements and align or shift the internal priorities and actions accordingly;
• Influencing/advocacy-able to determine a position and argue it effectively within the business context;
• Strong project management and prioritization skills, ability to effectively manage multiple tasks and priorities;
• Strong ability to guide change with global, cross-functional teams;
• Proven ability to drive operational excellence;
• Knowledge of and exposure to manufacturing or engineering processes.

• Drive priority Quality/Compliance programs and projects across the sites ensuring consistent project delivery and standardised process deployment;
• Influences the Quality Operations Leadership Team to drive ownership of Product Quality and Compliance with local site and functional teams;
• Drive the QO Lean and Digital journey ensuring successful and timely system deployments;
• Support and provide technical support for PDx Supply Chain Capacity Programs for both internal growth and integration of new collaborations and partnerships;
• Owns the Quality Lean Culture and is accountable for driving critical KPIs and Product Quality improvements to improve patient safety;
• Accountable for each of the metrics for the business (i.e. complaint investigation, internal audit score, product quality, employee engagement, etc.) and management review process.