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 setting.
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 laboratory quality
activities against defined internal and regulatory standards. The role ensures
efficient and effective workflows, procedures, policies, and laboratory
inspection programs are in place and adhered to across quality laboratory
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
laboratory and 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
laboratory quality assurance programs 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 laboratory quality activities and outputs
against internal and regulatory standards including 21 CFR Part 210 & 211 and
GMP guidelines
* Ensure efficient workflow, procedures, policies, and laboratory inspection
programs are implemented and maintained across quality laboratory operations
* Manage in-process product quality in coordination