Senior Specialist Quality Assurance

Senior Specialist responsible for quality oversight of GMP computerized systems and digital infrastructure across manufacturing, packaging, and laboratory operations at a pharmaceutical facility. Will ensure compliance with regulatory requirements, manage system validation throughout their lifecycle, and collaborate with cross-functional stakeholders to maintain data integrity and product quality.

Responsibilities

• Assess and remediate legacy computerized systems while evaluating and implementing new GxP-enabled solutions
• Provide independent quality approval of validation documentation, protocols, and system changes throughout lifecycle
• Review and verify compliance activities related to computerized systems are in place and effective
• Support regulatory inspections and audit activities, respond to findings, and drive resolution of non-conformance
• Mentor junior team members and promote GxP awareness and continuous improvement culture

Requirements

• Bachelor's degree in Science, Information Technology, Engineering, or equivalent
• Minimum 5 years regulated pharmaceutical manufacturing experience
• At least 3 years delivering validated IT solutions or application support in regulated environment
• Strong knowledge of FDA/EU/ICH regulations, 21 CFR Part 11, 210, 211, and 820
• Extensive knowledge of computerized system validation and compliance principles
• Hands-on experience with automated systems in pharmaceutical manufacturing or laboratory operations
• Practical experience implementing quality systems in GMP environments