Global Quality Assurance Auditor, Pharmacovigilance

GE HealthCare

9d • $102,320 - $153,480

About The Position

This role provides Quality Assurance auditing for the Pharmaceutical Diagnostics (PDx) business, with a focus on auditing and Global Compliance support for GMP manufacturing sites and Pharmacovigilance (PV)-related functions. The auditor conducts audits on behalf of CQA, with a particular focus on PV, and proactively shares insights and industry trends to support continued compliance and early identification of opportunities for improvement.

The position analyzes audit results and trends and supports the assessment and promotion of compliance within PV QA. It monitors changes to regulations and guidelines and provides QA oversight and support for updates to operating procedures, risk assessments, and change controls related to process changes and productivity or efficiency improvement initiatives. The role also supports regulatory inspections, customer audits, vendor qualification and surveillance, QMS improvements, and quality issues.

Requirements

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

Nice To Haves

• Strong oral and written communication skills.
• Demonstrated ability to analyze and resolve problems.
• Ability to document, plan, market, and execute programs.
• Established project management skills.
• Demonstrated experience applying classic Quality tools.
• Change-agent mindset with energy, passion, and enthusiasm to drive change.
• Demonstrated effective interpersonal, teamwork, and networking skills.
• Ability to influence, determine a position, and argue it effectively within the business context.

Responsibilities

• Support the planning, preparation, and execution of internal and external audits for QRA.
• Ensure identified actions and observations appropriately remediate deficiencies, are completed in a timely manner, and undergo effectiveness reviews.
• Work with customers to conduct risk analyses of systems and processes and propose process or functional audits.
• Support regulatory inspections and customer audits as a functional QA subject matter expert.
• Conduct trend analyses of audit and other quality-related data and share results with internal and external stakeholders as agreed.
• Ensure vendor qualification and surveillance activities are completed and documented in accordance with global and functional procedures.
• Participate in quality management system (QMS) improvements.
• Guide the appropriate setup of CAPAs, including risk assessment, effective corrective and preventive actions, and required evidence; perform QA approvals of Quality Event records.
• Keep up to date with guidelines from MHRA, FDA, EMEA, and other regulatory bodies; monitor legislation, implement changes, and inform the company of relevant changes.
• Provide Quality Assurance support, guidance, and management of assigned Quality Issues.
• Share insights and industry trends to support compliance and identify areas for continuous improvement.
• Provide QA oversight and support for updates to operating procedures, risk assessments, and change controls for process changes and productivity or efficiency improvement initiatives.

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• Paid time off
• 401(k) plan with employee and company contribution opportunities
• Life insurance
• Disability insurance
• Accident insurance
• Tuition reimbursement
• May be eligible for performance-based incentive compensation, which may include cash bonuses and/or long-term incentives

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level