[Hiring] Global Quality Assurance Auditor @GE HealthCare

Role Description

This role is responsible for providing QA auditing for the Pharmaceutical Diagnostics (PDx) business, focusing on auditing and Global Compliance support to the GMP manufacturing sites and Pharmacovigilance (PV) related functions.

• Perform audits on behalf of CQA with a focus on PV.
• Share insights and industry trends within the organization to ensure compliance and identify areas for continuous improvement.
• Provide analyses of audits/trends and support compliance promotion within PV QA.
• Stay aware of changes to regulations and provide support for updates to operating procedures, risk assessments, and change controls.

Qualifications

• Bachelor's degree from an accredited university or college (or a high school diploma/GED with at least 8 years of experience in the pharmaceutical industry).
• 6+ years of experience in the pharmaceutical industry.
• Previous auditing experience required.
• Experience interfacing with global regulatory agencies.
• Ability to comprehend and communicate key regulatory requirements and expectations.
• Experience in collaboration, negotiation & conflict resolution skills.
• Knowledge of GPvP, cGMP, and GDP.

Requirements

• Support a program of internal and external audits for QRA.
• Ensure all identified actions/observations are appropriate and completed in a timely manner.
• Work with customers to undertake risk analysis of systems and processes.
• Support regulatory inspections and customer audits as a functional QA subject matter expert.
• Conduct trend analysis of audit and quality-related data.
• Assure completion of vendor qualification and surveillance activities.
• Participate in quality management system (QMS) improvements.
• Provide guidance on CAPA setup and perform QA approvals of Quality Event records.
• Keep up to date with guidelines from MHRA, FDA, EMEA, and other regulatory bodies.
• Provide Quality Assurance support and management of Quality Issues as assigned.

Benefits

• Competitive pay range: $102,320.00 - $153,480.00 Annual.
• Performance-based incentive compensation, including cash bonuses and/or long-term incentives (LTI).
• Medical, dental, and vision insurance.
• Paid time off.
• 401(k) plan with employee and company contribution opportunities.
• Life, disability, and accident insurance.
• Tuition reimbursement.