Senior Quality Engineer

Job Responsibilities:

• Lead the development, implementation, and maintenance of quality systems and procedures to ensure compliance with regulatory requirements.
• Review and approve Change Control and Process Management Documents related to product or process modifications.
• Act as a key representative during on-site audits conducted by regulatory agencies, ensuring inspection readiness and compliance.
• Review and approve validation documents, requirement specifications, standard operating procedures (SOPs), and data integrity assessments.
• Collect, analyze, and report quality system data to monitor compliance, identify trends, and drive continuous improvement initiatives.
• Conduct internal quality audits, assess findings, and develop corrective and preventive action (CAPA) recommendations.
• Develop and refine procedures, conduct statistical evaluations, and implement system improvements to enhance quality and efficiency.
• Work effectively in a fast-paced, evolving environment while adapting to new challenges and regulatory expectations.
• Collaborate with internal and external teams, ensuring alignment on quality objectives and regulatory compliance.
• Promote a culture of quality and safety through training, awareness initiatives, and adherence to safety guidelines and SOPs.
• Ensure the proper maintenance of the department, facility, and equipment to uphold compliance and operational efficiency.
• Support the creation and review of product specifications, SOPs, and quality system documentation, contributing to Quality Review Board discussions.
• Ensure compliance with U.S. and international regulatory agencies and guidelines, including but not limited to FDA, EU, TGA, ISO, cGMP, and USP standards.
• Develop innovative solutions to complex quality challenges, ensuring alignment with organizational goals and industry best practices.
• Provide recommendations to management for enhancing operational processes, quality systems, and technological advancements.

Qualifications:

• Bachelor’s degree in Biology, Chemistry, Life Sciences, or a related field.
• At least 8 years of experience in Quality Assurance, Validation, or Quality Systems within a regulated manufacturing environment.
• Strong background in regulatory compliance, including direct involvement in on-site inspections and audits.
• Extensive experience in deviation investigations, root cause analysis, and corrective/preventive action implementation.
• Thorough understanding of validation principles, regulatory documentation, and industry best practices.
• Working knowledge of current Good Manufacturing Practices (cGMP) and their application in a controlled manufacturing or aseptic environment.
• Familiarity with regulatory guidelines related to facility systems, equipment qualification, and process validation.
• Experience with statistical tools and data analysis for process monitoring and quality improvements.
• Excellent communication and interpersonal skills to effectively interact with internal teams and regulatory agencies.