Senior Manager, Commercial Quality

About the role

Reporting to the Commercial Quality Senior Director, this position establishes and leads the quality management framework and quality system for the cluster, sets preventive and corrective actions to mitigate non-compliance risks and ensures compliance with world-class operational and customer-focused capabilities. It covers commercial quality operations across the LatAm clusters (Brazil/Southern and Mexico/Northern) and requires representing the region in global projects and initiatives.

Key responsibilities

• Lead the Cluster Commercial Quality organization and its quality assurance and quality systems, covering commercial activities and supporting handling, storage and distribution where applicable.
• Develop strategic and process performance measures and targets, and manage CAPA and risk management processes.
• Ensure QMS requirements are executed in line with local regulations, corporate and segment policies, and oversee SOPs for simplicity, standardization and education.
• Build relationships with partners and regulators, and act as a business partner for quality and process improvement.
• Ensure compliance with quality standards and regulatory requirements, and resolve quality issues using statistical analysis and process excellence tools.
• Present case studies and metrics to Cluster Leadership, coordinate internal and second-party audits, and lead the cluster's management review as Management Representative.
• Drive complaint vigilance, ensuring timely reporting and closure of product-related complaints, and propose quality performance improvement initiatives.
• Manage pharmacovigilance and post-market surveillance (technovigilance) systems within the cluster.
• Work with cross-segment leadership to sustain QMS initiatives, and strengthen quality and compliance capability through training, newsletters, conferences and quality week.

Required profile

• Ability to interact across segments and represent the region in global and regional forums.
• Leadership of the Cluster Commercial Quality organization and team management.

Required skills

• Quality Management Systems (QMS) and Quality Control (QC)
• Corrective and Preventive Action (CAPA) and risk management
• Standard Operating Procedures (SOP) and ISO 9001
• Pharmacovigilance and post-market surveillance