Senior Analyst, PQA

Role Summary

The Senior Analyst, Post-Market Surveillance is part of AbbVie's Medical Device Center within the Shared Services function (MDCSS). This role’s primary focus is Post-Market Risk and reports to the Manager, Post-Market Device Quality (or equivalent). The role performs a variety of tasks related to maintenance and post-market evaluation of the Quality Management System pursuant to regulatory and statutory requirements (21 CFR 820, MDR 2017/745, EN ISO 13485). Primary responsibility is Post-Market Reporting (e.g., PMCF, PMSR, PSUR, etc.), however the role may also entail analyzing complaints, analyzing post-market signals, collecting data, and evaluating other measures of product performance (e.g., CAPA/NCR). The Senior Analyst, Post-Market Surveillance serves as a cross-functional team advocate, tasked with assuring stakeholder concerns are addressed during planning and/or execution of assigned activities.

Responsibilities

• Assess trends escalated by Signal Detection, as assigned
• Conduct investigations for CAPAs, NCRs, Observations, etc.
• Coordinate and schedule post-market reporting activities (e.g., CERs, PMCFP/PMCFR, PMSP/PMSR/PSURs, etc.)
• Author or update Post-Market Reporting documents (e.g., PMCFP/PMCFR, PMSP/PMSR/PSURs, PRER, etc.)
• Work with internal business partners to ensure timely collection and assessment of relevant data (e.g., complaint trends, literature reviews, medical assessments) to drive evidence-based conclusions regarding product performance and safety
• Escalate discrepancies and confirmed or potential Quality issues to management
• Develop Quality Plans and manage projects, as assigned
• Support interactions with regulatory authorities (e.g., Notified Body audits)
• Write and revise process-related procedures, forms, and other documents, as needed

Qualifications

• Required: Bachelor’s degree in Engineering or Science
• Required: Six years of experience within Pharmaceutical operations, preferably Biologic manufacturing process
• Required: Knowledge of GMP regulations and standards affecting pharmaceutical products
• Required: Comprehensive knowledge and application of business and quality concepts
• Required: Strong analytical skills and attention to detail
• Preferred: Change control plans, Exception Reports, SAP and LRMS experience
• Required: Proven ability to adapt communication style for a variety of modes as well as for multicultural audiences
• Required: Strong interpersonal relations / communications skills. Ability to effectively communicate across all levels of the organization