Global Quality Assurance Auditor, Pharmacovigilance

This is a fully remote position, open to applicants in United States.

📋 Description

• Plan, prepare, and execute both internal and external audits for QRA.

• Ensure that audit actions and observations effectively address deficiencies and are completed within the designated timeframe.

• Review completed actions to assess their effectiveness.

• Conduct risk analyses of systems and processes in collaboration with customers.

• Recommend process and functional audits.

• Serve as a functional QA subject matter expert during regulatory inspections and customer audits.

• Perform trend analyses of audit and other quality-related data.

• Deliver audit and quality data analyses to both internal and external stakeholders.

• Ensure the completion and documentation of vendor qualification and surveillance activities.

• Engage in quality management system enhancements.

• Offer guidance on CAPAs, including risk assessment, corrective and preventive actions, and required documentation.

• Conduct QA approvals of Quality Event records.

• Monitor guidelines and legislation from MHRA, FDA, EMEA, and other regulatory bodies.

• Assist with updates to operating procedures, risk assessments, and change controls.

• Notify the company of pertinent regulatory changes.

• Provide Quality Assurance support, guidance, and management of assigned Quality Issues.

• Share insights and industry trends to foster ongoing compliance and continuous improvement.

⛳️ Requirements

• Bachelor's degree from an accredited university or college, or a high school diploma / GED with a minimum of 8 years of experience in the pharmaceutical industry.

• At least 6 years of experience in the pharmaceutical sector.

• Previous auditing experience is mandatory.

• Familiarity with interfacing with global regulatory agencies.

• Ability to understand and communicate essential regulatory requirements and expectations.

• Experience in collaboration, negotiation, and conflict resolution.

• Knowledge of GPvP, cGMP, and GDP regulations.

• Strong oral and written communication capabilities.

• Proficiency in analyzing and resolving problems.

• Ability to document, plan, market, and execute programs effectively.

• Established skills in project management.

• Proven experience in applying classic Quality tools.

• Demonstrated strong interpersonal, teamwork, and networking abilities.

• Capacity to influence and advocate for a position effectively within a business context.

• Legally authorized to work in the United States.

• Willingness to undergo a drug screening, as required.

🏝️ Benefits

• Medical insurance.

• Dental insurance.

• Vision insurance.

• Paid time off.

• 401(k) plan with opportunities for employee and company contributions.

• Life insurance.

• Disability insurance.

• Accident insurance.

• Tuition reimbursement.

• Professional development opportunities.

• Competitive compensation.

• Performance-based incentive compensation, which may include cash bonuses and/or long-term incentives (LTI).