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Bracco · 1 week ago

Manager, Quality Compliance & Continuous Improvement

Princeton, NJ

Full-time

Hybrid

Mid, Senior Level

5+ years exp

Bracco Diagnostics Inc. is a subsidiary of Bracco Imaging specializing in diagnostic contrast imaging agents. The Manager, Quality Compliance & Continuous Improvement will support continuous improvement initiatives within the Quality Management System and oversee quality activities to ensure compliance with regulatory requirements.

Health CareHealth DiagnosticsMedical

Hiring Manager

Michaela Benemar

Responsibilities

Lead and coordinate continuous improvement projects within the Quality Management System (QMS), driving efficiency and effectiveness across the organization

Support the Director, Quality Compliance & Risk Management in strategic and operational initiatives, including risk assessments, compliance monitoring, and process optimization

Collaborate with Corporate Quality Management and cross-functional teams to ensure alignment with Bracco procedures, guidelines, and regulatory requirements

Prepare and escalate quality KPIs and metrics to Quality Management Team

Facilitate the definition, implementation, and monitoring of quality improvement initiatives

Prepare reports, presentations, and analyses to support quality and risk management decision-making, including escalation of quality KPIs and metrics

Serve as a key contributor for inspection readiness, including preparation, logistics, and execution of inspection activities

Mentor and support quality team members in continuous improvement methodologies, quality risk management, and best practices

Other duties as directed by the Director, Quality Compliance & Risk Management and Quality Management Team

Qualification

Quality Management SystemCGMP knowledgeProject ManagementRisk ManagementData AnalysisComputer Systems ValidationCommunicationInterpersonal SkillsOrganizational SkillsTeam Collaboration

Required

Bachelor's degree in a science-related field preferred, or equivalent with a minimum of five years of experience in quality assurance within pharmaceuticals and/or medical devices

Demonstrated knowledge and experience in project management, risk management, quality management maturity, automation and digitalization systems, computer systems validation and regulatory inspection logistics

Working knowledge of the current cGMPs (ex. 21 CFR Part 7, 11,117, 210, 211, 807, 820), ISO 13485, and ISO 14971

Proven project management skills with success in leading cross-functional teams

Proficiency in Microsoft Office Suite, SharePoint, TrackWise, MS Teams, SuccessFactor, etc

Experience with data analysis using Power BI or equivalent

Strong communication skills, ability to influence for quality results

Ability to work cross-functionally across multiple departments and organizations

Strong organizational skills, detail oriented and able to communicate effectively

Strong interpersonal skills and ability to work in a team environment