Senior Analyst, PQA
The Senior Analyst, Post-Market Surveillance is part of AbbVie’s Medical Device Center within the Shared Services function (“MDCSS”). This position’s primary focus is on 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.
- 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
- Bachelor’s degree preferably in Engineering or Science
- Six years of experience within the Pharmaceutical operations, preferably Biologic manufacturing process
- Knowledge of GMP regulations and standards affecting pharmaceutical products
- Comprehensive knowledge and application of business and quality concepts
- Strong analytical skills and attention to detail
- Change plan, Exception Reports, SAP and LRMS experience is highly preferred
- Proven ability to adapt communication style for a variety of modes as well as for multicultural audiences
- Strong interpersonal relations / communications skills. Ability to effectively communicate across all levels of the organization
Preferred Qualifications
- Experience with ComplianceWire, Global TrackWise, and/or OneVault
- Experience working with EU MDR 2017/745, 21 CFR 820
- Working knowledge of current MDCG relevant to Post-Market Reporting
- Experience with post-market reporting and/or data analysis
- Scientific/Medical background
- ASQ Certification (e.g., CQA, CQE) or equivalent
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time ofthis posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location,and we may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of anybonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's soleand absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
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