Position Details

Type Full-Time

Experience senior

Exp. Years 6 years

Education Bachelor's degree in Engineering or Science

Category Healthcare & Medical

About this role

Senior Quality Engineer focusing on risk management for Third Party Manufacturing (TPM) and Product Quality Assurance (PQA) across TPM sites, ensuring cGMP compliance, investigations, CAPA, and regulatory alignment.

Key Responsibilities

Review and approve manufacturing directions to the production floor
Review and approve manufacturing, laboratory, and raw material investigations
Perform annual Product Quality Review
Participate in Trend Review Board
Participate in Global Change Review Board (GCRB) and evaluate supplier change notifications

Technical Overview

QA operations, GMP/cGMP compliance, investigations, CAPA, PQR/APQR, supplier changes, SAP/LRMS systems, trend analysis, and regulatory submission coordination.

Ideal Candidate

The ideal candidate is a senior quality engineer with 6+ years of pharmaceutical operations experience, skilled in TPM/PQA activities, GMP/compliance, and cross-functional collaboration. They should have strong analytical abilities, a proven track record of CAPA and investigations, and hands-on SAP/LRMS experience to support regulatory submissions and continuous improvement.

Must-Have Skills

Bachelor's degree in Engineering or Science6 years of experience in pharmaceutical operationsKnowledge of GMP regulations and standardsStrong analytical skillsAbility to communicate across all levels

Nice-to-Have Skills

Experience with SAPLRMS

Tools & Platforms

SAPLRMS

Required Skills

Bachelor's degree in Engineering or Science6 years of pharmaceutical operationsGMP knowledgeanalytical skillscross-level communicationSAPLRMSCAPAinvestigationschange managementPQATPMTPM site coordinationProduct Quality Reviewregulatory submissions

Hard Skills

GMPcGMPQuality AssuranceQuality InvestigationsCorrective and Preventive Action (CAPA)Change ManagementProduct Quality Review (PQR)Annual Product Quality ReviewSupplier Change NotificationThird Party Manufacturing (TPM)SAPLRMSTrend ReviewRegulatory submissions coordination

Soft Skills

Analytical thinkingAttention to detailInterpersonal communicationCross-functional collaborationCommunication across multicultural audiencesPlanning and risk analysis

Industry & Role

Industry Healthcare & Medical

Job Function Quality assurance oversight and risk management for TPM operations and PQA across AbbVie TPM sites.

Role Subtype Quality Engineer

Tech Domains SAP

Keywords for Your Resume

Senior Quality EngineerRisk ManagementThird Party ManufacturingTPMPQAQuality AssuranceGMPcGMPQuality InvestigationsCAPAChange ManagementProduct Quality ReviewPQRAnnual Product Quality ReviewSAPLRMSSupplier Change Notificationinvestigationsmanufacturing directionregulatory submissionTrend Review BoardGCRBGlobal Change Review BoardSix years of experience

Deal Breakers

Less than 6 years of pharma operations experience, Lack of GMP knowledge, No SAP or LRMS experience

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Senior Quality Engineer, Risk Management

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