Senior quality assurance specialist

Job Title: Senior Quality Assurance Specialist

A senior quality assurance specialist plays a critical role in ensuring that all operations align with good manufacturing practice (GMP) principles and regulatory expectations from agencies such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

Key Responsibilities:
* Lead the quality review and approval process for changes, deviations, and standard operating procedures (SOPs), ensuring full compliance with GMP and site-specific requirements.
* Manage quality operational duties related to product disposition, ensuring timely and compliant decision-making.
* Monitor and evaluate new regulatory guidance and industry best practices, assessing their impact on quality systems and driving necessary updates.
* Assist in developing and maintaining quality policies, SOPs, and reports that support site operations and compliance.
* Champion continuous improvement initiatives by identifying opportunities to enhance quality processes and operational efficiencies.
* Participate in risk management activities, applying relevant guidance and industry best practices to mitigate potential quality risks.


Qualifications & Experience:
* Degree in science, quality, or a related 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, capable of clearly articulating complex quality issues.
* Proven ability to work effectively both independently and collaboratively within a team.
* Exceptional attention to detail and precision in preparing and reviewing GMP documentation.
* Hands-on experience with quality management systems such as Veeva, SAP, PAS-X, or similar platforms.