Product Quality Senior Manager
Core
Ensures quality and compliance for pharmaceutical, biologics, device, and combination products across AbbVie plants and third-party manufacturers to meet business objectives and regulatory standards.
Role type
Senior Product Quality Manager (Pharmaceuticals/Biologics/Devices)
Builds
Pharmaceutical, biologics, device, and combination products for AbbVie and partners
Domain
Life Sciences / Pharmaceutical Manufacturing / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> product features (Quality Release & Compliance)
Required skills
Quality Assurance Operations Management, Third-party manufacturing oversight, Regulatory agency interaction (FDA), Corrective and Preventive Actions (CAPA), Audit management, Annual Product Review analysis, Technical problem resolution, Strategic quality planning
Preferred skills
Direct manufacturing plant experience in pharmaceutical settings, Knowledge of sterile/biological/liquid/solid device technologies
Technologies
None explicitly listed as tools/frameworks
Responsibilities
Lead project activities and team members to achieve on-time quality deliverables; Develop and implement global Product Quality Assurance strategy; Perform final quality release of manufactured product lots; Make recommendations on quality/compliance decisions and elevate high-risk events; Establish relationships with third-party manufacturers and internal sites; Negotiate with external quality organizations to balance compliance and cost; Manage audit plans, inspection readiness, and corrective action timetables; Support new product launches and compliant trend investigations; Review Annual Product Reviews and Quality Reports from third-party manufacturers.
Seniority
Senior, hands-on IC with management oversight
