Responsibilities:
- Perform real-time review of investigations/post-market complaints to assess robustness and ensure appropriate corrective/preventive actions based on root cause and impact.
- Review and participate in investigations for critical quality events/escalations; provide guidance for continuous compliance and quality improvement.
- Review and participate in investigations for supplier non-compliance/escalations; provide guidance for continuous compliance and quality improvement.
- Provide timely reporting of analyzed data through governance and escalate critical findings to global and regional quality management.
- Assess Global SOPs/Policies vs. site SOPs; communicate enhancement opportunities to sites.
- Prepare and present monthly metrics summaries for investigation review key attributes.
- Routinely interact with stakeholders at site, regional, and global levels.
- Stay current with industry standards and interpretations of key regulations; apply learnings to process enhancements.
- Monitor and respond to investigation-metrics KPIs across assigned regions/sites to mitigate business risk.
- Travel: 10%β20% domestic/international (or as necessary).
Minimum Qualifications:
- Bachelorβs degree (or equivalent) and 4β7 years of experience (or equivalent combination of education/experience).
- Knowledge of regulatory agencies; expert-level knowledge of quality investigations and related practices/processes/policies/procedures.
- Strong leadership, analytical/strategic/system thinking, independent judgment, innovation/creativity/resourcefulness.
- Computer skills; working knowledge of Microsoft Office.
- Read/interpret complex technical/business documents; write comprehensive reports and correspondence; present to groups.
- Perform calculations (percentages, ratios, rates); draw/interpret graphical data (pharmaceutical calculations preferred).
- Problem-solving for moderately complex issues; follow prescribed/detailed procedures.
- English proficiency (speaking, comprehending, reading, writing).