Healthcare Quality Assurance & Regulatory Affairs Senior Director

The QA & RA Senior Director CANADA (RQA) is responsible for the oversight and implementation of the UPS Healthcare Quality Management System (QMS), UPS Healthcare Standard Operating Procedures (SOPs), processes and policies required to manage and control UPS Healthcare's Storage, Distribution and Transportation Facilities in Canada.

The Quality Management System encompasses current requirements of Health Canada, Good Manufacturing Practice (GMP), Good Distribution Practices (GDP), Good Storage Practices (GSP), ISO 13485 and ISO 9001.

Key Responsibilities

Provide Quality leadership and oversight of Sr QA Managers, QA Managers and QA Specialists to ensure consistent implementation of the UPS Healthcare QMS at all Canadian locations

Communicate and maintain the UPS Healthcare quality plan to sustain compliance with quality system requirements

Perform internal audits, host client audits, and audit external service providers

Manage discrepancies, issues, and CAPA plans; collate data; and implement quality improvement initiatives

Identify Quality KPIs, collate KPI data, and produce metrics to monitor and drive continuous improvement

Coordinate and lead the Regional Quality Council and contribute to the Global Quality Council

Oversee validation, calibration, and preventative maintenance programmes regionally

Identify training needs and deliver SOP training to staff and third-party providers

Support strategic quality initiatives in partnership with the VP of Quality

Requirements

Bachelor's degree or equivalent combination of relevant education and professional experience

7+ years of relevant experience including Quality and Logistics Management

Deep knowledge of Health Canada, GMP, GDP and ISO Compliance

5+ years of pharmaceutical/biotechnology industry experience

ASQ or ISO Certification preferred

Willingness to travel approximately 25%

Total target compensation up to $237,000 CAD (excluding pension and benefits). UPS is a diverse and equal opportunity employer.

#J-18808-Ljbffr