Senior Executive, Quality Assurance

Description:

This role is responsible for defining and specifying the activities, processes, and standards required to fulfill quality requirements for manufactured materials, components, and products within a global pharmaceutical environment. The position builds and maintains the infrastructure and systems necessary to consistently ensure the timely delivery of quality-compliant products. It supports the auditing, monitoring, and evaluation of manufacturing processes and outputs against defined internal and regulatory standards. The role ensures efficient and effective workflows, procedures, policies, and inspection programs are in place and adhered to across manufacturing operations. It manages in-process product quality in coordination with vendors and contract manufacturers. The position facilitates communication with customers and vendors to resolve quality-related issues in a timely and compliant manner. It reports and troubleshoots manufacturing process deviations and defects identified in finished goods. The role contributes to continuous improvement initiatives aimed at reducing defects, errors, and rework across manufacturing operations. It also supports the identification and development of outsourcing vendors and suppliers according to organizational quality standards.

Essential Functions:

• Define and specify quality activities, processes, and standards for manufactured materials, components, and products in compliance with regulatory requirements

• Build and maintain quality infrastructure and systems to ensure timely delivery of compliant pharmaceutical products

• Conduct audits and monitoring of manufacturing processes and outputs against internal and regulatory standards including 21 CFR Part 210 & 211 and GMP guidelines

• Ensure efficient workflow, procedures, policies, and inspection programs are implemented and maintained across manufacturing operations

• Manage in-process product quality in coordination with vendors and contract manufacturers to meet defined quality specifications

• Communicate with customers and vendors to investigate and resolve quality-related issues in a timely manner

• Report and troubleshoot manufacturing process deviations and defects identified in finished goods

• Identify and implement process improvements to reduce costs, defects, errors, and rework in manufacturing operations

• Support the identification and development of outsourcing vendors and suppliers according to organizational quality standards and policies

Additional Responsibilities: Education:

• B. Pharm B. Pharm - Required

• M. Pharm M. Pharm - Preferred

Experience:

• 5 years or more in 5 - 8 Years

Specialized Knowledge: Licenses: