ROLE SUMMARY

The Global Clinical Supply (GCS) Quality Investigation Lead (QIL) Senior Associate is a position within the GCS Strategic Hubs (GSH) team and will be based in Costa Rica. The QIL Senior Associate will be reporting to the GSH Team Lead in Costa Rica, with a matrix reporting relationship to the Inspection and Risk Management (IRM) Senior Director.

The GCS Inspection and Risk Management Group instills concepts quality and regulatory compliance through GCS to ensure that clinical trial projects meet internal and external standards and withstand Regulatory Inspections. This includes ensuring quality investigations are conducted efficiently and completely.

The position includes interactions primarily with GCS colleagues at various levels, internal stakeholders, including representatives from Clinical Development & Organization and Pharmaceutical Science. The GCS QIL, Senior Associate will be accountable for managing quality investigation records through initiation, the investigation process including root cause analysis and Pfizer Human Performance (PHP) analysis, to record close.

• Ensure that each record is thoroughly investigated, meeting investigation timelines and completing necessary pre-work to enable an investigation with appropriate quality outcomes. Additionally, implement effective and well-written documentation practices and give feedback for improvement and proactively come up with solutions to challenges observed.
• Independently own and drive basic and moderate complexity level records, more complex records may be assigned with mentor or manager oversight.
• Drive actions in a matrix environments ensuring investigation details are complete from other Subject Matter Experts (SMEs).
• Serve as SME for GCS Inspection & Risk Management group by creating guidance and providing trainings for other QILs' investigations.
• Perform activities in compliance with SOPs and Veeva Vault system procedures or equivalent system.
• Independently utilize root cause analysis tools to drive investigations to proper closure and implement required remediations with oversight and support.
• Utilize Pfizer Human Performance tools with limited oversight and support.
• Properly escalate concerns to leadership and designated quality forums regarding investigation progress or CAPAs implementation for a timely resolution.
• Manage extension requests actions and CAPA effectiveness checks, allowing approvers adequate time to approve within the required timeframe and prior to due date.
• Facilitate GCS cross-functional lines and QA to investigate, document and drive to accurate and effective closure of records.
• Develop and present on findings, trends, issues or metrics.
• Support audit and regulatory activity as necessary.
• Manage the record due dates schedule across GCS and QA to prevent due date clustering around holidays and year-end.
• Coordinate and participate in wider initiatives such as process improvements.
• Utilize Spotfire or similar visualization tools.
• Attend GCS Quality Governance meetings as needed.
• Attend periodic meetings with teams in alternative global time zones, highlighting the role's requirement for global collaboration and communication.

• Bachelor's Degree
• At least 3 years of pharmaceutical experience in clinical studies, investigational supplies, supply chain, or GMP/GCP Quality.
• Fluent in verbal and written English.
• Ability to work independently seeking guidance as needed.
• Ability to function in a matrix model, collaborate in a team environment.
• Technical or equivalent writing skills.
• Strong and effective written and verbal communication skills.
• Excellent interpersonal effectiveness skills.
• Attention to detail.
• Decision making to resolve moderately complex standards situations based on guidelines and policies. Technical proficiency/expertise, including skills in use of common desktop tools (MS Word, MS Excel, MS Project, Visio); Office365 and SharePoint.

• Experience in clinical trial processes and relationships.
• Knowledge of GCP requirements and applicable SOPs and regulations.
• Knowledge of GMP requirements and applicable SOPs and regulations.
• Strong project management, administrative, and technical capabilities.
• Quality or compliance experience.
• Scientific background in Life Sciences, Regulatory Affairs, or higher degree preferred.
• Training and proficiency in root cause analysis methodology preferred.
• Strong organizational skills and ability to prioritize. multiple projects and meet targeted deliverables and deadlines
• Ability to adapt to changing situations and work well under pressure.
• Experience with tools for analysis and graphing; reporting (Spotfire); and systems for document management and learning management.