Qualifications

• 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.
• Logical thinker with the ability to remain proactive and composed under pressure.
• 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, Client-X, or similar platform

As a Senior QA Specialist, you will be a key driver of quality assurance activities at our site, ensuring that all operations align with cGMP principles and regulatory expectations from agencies such as the FDA and EMEA. You will take ownership of maintaining compliance within your assigned areas, working closely with cross-functional teams to uphold the highest standards of quality and regulatory adherence.

Responsibilities

• Lead the QA review and approval process for Change Controls, Deviations/CAPAs, SOPs, and related documentation, ensuring full compliance with GMP and site-specific requirements.
• Manage QA 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 QA 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.

• Support and execute the internal audit program, including conducting audits as required to ensure ongoing compliance and improvement.

  Qualifications

• 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.
• Logical thinker with the ability to remain proactive and composed under pressure.
• 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, Client-X, or similar platforms