Lead Specialist Quality Assurance
Core
Conduct quality oversight and compliance activities for third-party manufacturing (TPM) partners to ensure adherence to Abbott, internal, and external regulatory requirements.
Role type
Lead Specialist Quality Assurance (TPM Oversight)
Builds
Quality compliance readiness and oversight for third-party manufacturing partners
Domain
Medical Devices / Pharmaceutical Manufacturing
Deliverable
client delivery
Required skills
Quality system compliance, regulatory requirements knowledge, data analysis, project management, cross-functional collaboration, documentation review, scorecard management, SCAR management, coaching and training
Preferred skills
Medical device or pharmaceutical manufacturing quality experience, successful project delivery history
Technologies
None stated
Responsibilities
Manage TPM oversight activities including scorecards, communications, and SCARs; Provide quality support and oversight of compliance readiness activities; Review documentation for accuracy, clarity, consistency, completeness, and compliance; Analyze data, procedures, and requirements to ensure quality and compliance; Coordinate activities across multiple project groups; Provide guidance, coaching, and training to various functions and colleagues
Seniority
Senior, hands-on IC
