Quality Assurance Manager Role
Skillfully leading quality assurance initiatives at a top pharmaceutical multinational, ensuring seamless operations in line with cGMP principles and regulatory standards from agencies like the FDA and EMEA.
* Lead the review and approval process for Change Controls, Deviations/CAPAs, SOPs, and related documentation, guaranteeing full compliance with GMP and site-specific requirements.
* Manage QA operational duties related to product disposition, ensuring timely and compliant decision-making.
* Monitor new regulatory guidance and industry best practices, assessing their impact on quality systems and driving necessary updates.
Key Responsibilities:
* Review and approve Change Controls, Deviations/CAPAs, SOPs, and related documentation.
* Manage product disposition operational duties.
* Assess regulatory guidance and industry best practices impact.
Requirements:
* Degree in Science, Quality, or Technical field.
* 5-10 years of experience in Quality Assurance, Quality Control, or Technical Operations within FDA/EMEA regulated environments.
* Strong written and verbal communication skills.