Hc Senior Manager Healthcare QA Governance

UPS Türkiye

We are looking for a Healthcare Compliance (QA) Senior Manager Governance to work at UPS Healthcare.

Summary

The Healthcare Compliance (QA) Senior Manager Governance is part of the Healthcare Compliance Governance team as process owner for key elements of the Quality Management System and he/she reports to the Global Director QA Governance.

JOB PURPOSE AND KEY RESPONSIBILITIES

·       Process owner and responsible for developing and maintaining the UPS SCS Global Healthcare NC, CAPA, Complaints, CC and QRM policies and procedures to ensure continual compliance to regulatory, internal and customer expectations

·       Defines and oversees the electronic record keeping requirements and associated data and reporting requirements associated with the owned processes.

·       Advises senior management of process issues and QMS performance and provides continued management escalation and oversight to assure continued overall global compliance to owned QMS requirements

·       Management review of critical events and risks for global PA opportunities.

·       Responsible for monitoring, reporting and communicating issues, trends, risks and performance to UPS SCS senior management.

·       Overall process owner for the global controlled documents that establish the global Quality Management System Standards, including responsibility and oversight for the Quality Standards Board (QSB)

·       Overall process owner and management of the Global Escalation Board that reviews and provides direction on significant compliance issues such as critical NCs, high impact CCs and risks

·       Subject matter expert for owned QMS processes including continued education and research as well as representing these areas of the QMS for problem solving and addressing questions during regulatory inspection

KNOWLEDGE AND EXPERIENCE

·       Must have a Bachelor’s Degree (or internationally comparable degree) or higher in a technical discipline such as Science or Engineering

·       Proficiency in English   

·       Minimum 5 years of working experience in a leadership role involving technical or analytical personnel

·       Must have previous QA experience at a senior leadership level in a cGMP/ISO/healthcare environment

·       Strong understanding and experience working with the various components of Quality Management Systems & cGMP requirements

·       Previous experience in investigations, managing complaints, risk assessment, program/project management or quality oversight in cGMP/healthcare environment

·       Experience in Lean Six Sigma methodologies would be an asset