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 up preventive and corrective actions to mitigate non-compliance risks and ensures compliance with world-class, customer-focused capabilities. It covers the commercial quality operations of the Latin American 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 lead CAPA and risk management processes.
• Manage SOPs so they are simple, standardized and understood across countries, and act as a business partner for quality and process improvement.
• Ensure compliance with quality standards, regulatory requirements and local warehouse and distributor regulations, and lead the management review as Management Representative.
• Drive complaint vigilance, with timely reporting and closure of product-related complaints, and coordinate internal and second-party audits.
• Manage pharmacovigilance and post-market surveillance systems within the cluster.
• Build relationships with partners, regulators and cross-segment leaders, and strengthen quality and compliance capability through training, newsletters, conferences and quality week.
• Represent the region in global and regional forums and propose quality performance improvement initiatives.

Required profile

• Ability to interact across segments and represent the region in global projects and initiatives.
• Leadership of the cluster's quality organization and process improvement teams.

Required skills

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