Manager, Quality Compliance & Continuous Improvement - Bracco Diagnostic, Inc

Manager, Quality Compliance & Continuous Improvement - Bracco Diagnostic, Inc page is loaded## Manager, Quality Compliance & Continuous Improvement - Bracco Diagnostic, Incremote type:
Hybrid locations:
Princeton, New Jersey, 08540, USAtime type:
Full time posted on:
Posted Yesterday job requisition id Bracco Diagnostics Inc. is a subsidiary of Bracco Imaging which is part of the overall Bracco Group.  The Company specializes in the clinical development, marketing and sales of diagnostic contrast imaging agents.  Bracco Diagnostics Inc. primarily markets its products to hospitals throughout the United States. Bracco Diagnostics Inc. is committed to the discovery, development, manufacturing and marketing of imaging agents and solutions aimed at providing a better use and management in terms of diagnostic efficacy, patient safety and cost effectiveness.

This Manager, Quality Compliance & Continuous Improvement supports continuous improvement initiatives within the Quality Management System, assisting the Director of Quality Compliance & Risk Management with risk assessments, compliance monitoring, and process optimization. It oversees quality activities in alignment with cGMPs, SOPs, and regulatory requirements, collaborates with Corporate Quality and cross-functional teams, prepares and escalates quality metrics, and helps define, implement, and monitor quality improvement efforts.

The Manager, Quality Compliance & Continuous Improvement is a key member of the Quality Organization, responsible for leading continuous improvement projects and supporting the Director, Quality Compliance & Risk Management in all aspects of quality and risk management. The Manager will coordinate, perform, and maintain quality activities in accordance with cGMPs, Standard Operating Procedures, and company and regulatory requirements, ensuring the highest standards of compliance and operational excellence.
** Main Responsibilities, Activities, Duties and Tasks
*** 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.
** Education
* * 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.
** Professional Experience, Knowledge & Technical Skills
*** 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, Track Wise, MS Teams, Success Factor, 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…