Global Quality Assurance Auditor, Pharmacovigilance

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

📋 Description

• Conduct quality assurance auditing for the Pharmaceutical Diagnostics sector, with a focus on GMP manufacturing locations and Pharmacovigilance-related tasks.

• Organize, prepare, and implement both internal and external audits for Quality Risk Assessment (QRA).

• Ensure that audit actions and findings adequately address deficiencies and are completed in a timely manner; assess their effectiveness.

• Collaborate with clients to carry out risk assessments of systems and processes, and suggest process/functional audits.

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

• Perform trend analysis of audit and quality-related data for both internal and external stakeholders.

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

• Engage in improvements for the quality management system.

• Oversee the setup of Corrective and Preventive Actions (CAPA) and conduct QA approvals of Quality Event records.

• Keep track of MHRA, FDA, EMEA, and other regulatory guidelines and legislation; implement and communicate relevant updates.

• Offer QA support, guidance, and management for assigned Quality Issues.

• Actively share industry trends and insights to foster compliance and continuous improvement.

⛳️ Requirements

• A 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 sector.

• A minimum of 6 years of experience in the pharmaceutical industry.

• Previous auditing experience is mandatory.

• Familiarity with global regulatory agencies is essential.

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

• Experience in collaboration, negotiation, and conflict resolution.

• Knowledge of Good Pharmacovigilance Practices (GPvP), current Good Manufacturing Practices (cGMP), and Good Distribution Practices (GDP).

• Strong verbal and written communication skills.

• Proficient in analyzing and resolving problems.

• Capability to document, plan, market, and execute programs.

• Proven project management skills.

• Experience in utilizing classic Quality tools.

• Effective interpersonal skills, 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; employment visa sponsorship is not available.

• Successful completion of a drug screen, if applicable.

🏝️ Benefits

• Medical, dental, and vision insurance.

• Paid time off.

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

• Life, disability, and accident insurance.

• Tuition reimbursement.

• Professional development opportunities.

• Challenging career paths.

• Competitive salary packages.

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