Sr. Manager, Central Quality Audit

GE HEALTHCARE • OH

118d • $119,200 - $178,800

About The Position

Managing, ensuring and improving capabilities to comply with external standards and regulations. Interprets internal and external business challenges and recommends best practices to improve products, processes or services. Stays informed of industry trends that may influence work. GE Healthcare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. 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.

Requirements

• Qualified Lead Auditor with active certification.
• Bachelor's Degree.
• 5+ years’ experience in the pharmaceutical industry; or a High School Diploma and a minimum of 10 years' of progressive responsibility in the pharmaceutical industry.
• Minimum of 5 years’ experience driving Global programs to resolve quality compliance issues.
• Experience with Pharmaceutical QMS requirements and regulatory requirements including cGMP, GDP, GPvP, GCP and GLP.
• Experience with Artificial Intelligence.

Nice To Haves

• Master's Degree.
• Prior health authority experience.
• IRCA, ASQ (CQE, CQA, etc.) and/or Lean Certification (green belt, black belt).
• Extensive experience in the Pharmaceutical industry.
• Understanding of product quality improvement using tools such as Six Sigma, DFR.
• Demonstrated ability to analyze and resolve problems.
• Exceptional conflict-resolution skills.
• Strong oral and written communication skills in English.

Responsibilities

• Executes against GEHC's Central Quality & Regulatory Audit program, including scheduling, preparation, execution, reporting, and follow-up activities associated with Central Quality & Regulatory Internal Audits.
• Identifies and communicates high-risk issues; reports compliance concerns and recommended improvements to business leadership.
• Ensures audit strategy is executed to current industry practices and regulatory expectations.
• Supports GEHC Health / Competent Authority audits, including preparation, back-room management, tracking of Lessons Learned, and driving follow-up activities.
• Supports GEHC Quality Management System by defining, tracking, and maintaining metrics to promote early awareness and visibility of Quality & Regulatory issues.
• Regularly advises management in Central Quality.
• Leads functional teams or projects with indirect resources and medium to high risk and/or complexity.
• Communicates difficult concepts and influences others' opinions on topics.
• Develops self and others by promoting strong Quality & Regulatory practices, providing feedback, training, and mentorship.

Benefits

• Medical, dental, vision insurance.
• Paid time off.
• 401(k) plan with employee and company contribution opportunities.
• Life, disability, and accident insurance.
• Tuition reimbursement.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees