A Quality Assurance Manager in a biotech company ensures that all products meet regulatory standards and internal quality requirements through rigorous testing and process audits. They develop and implement quality control procedures to maintain compliance with industry regulations such as FDA and GMP guidelines. Collaborating with cross-functional teams, they drive continuous improvement and manage documentation to support product safety and efficacy.
Develop and implement quality management systems (QMS)
Develop and implement quality management systems (QMS) that ensure compliance with industry standards such as ISO 9001 and improve overall organizational efficiency. Monitor process performance through rigorous data analysis and continuous improvement techniques to drive product quality and customer satisfaction. Collaborate with cross-functional teams to align quality objectives with business goals and provide training to enhance adherence to quality protocols.
Oversee regulatory compliance (GMP, GLP, ISO)
Manage and enforce strict adherence to Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and ISO standards to ensure organizational compliance and quality assurance. Conduct regular audits and implement corrective actions to address non-compliance risks and maintain certification status. Collaborate with cross-functional teams to update policies and provide training on regulatory requirements for continuous improvement.
Conduct internal and external audits
Conduct comprehensive internal and external audits to evaluate compliance with regulatory standards and organizational policies. Identify discrepancies, assess risk management procedures, and recommend actionable improvements to enhance operational efficiency. Collaborate with department leaders to implement audit findings and ensure continuous adherence to best practices.
Manage deviation, CAPA, and change control processes
Manage deviation, CAPA, and change control processes to ensure compliance with regulatory standards and continuous improvement in quality management systems. Analyze investigation reports, implement corrective and preventive actions, and coordinate cross-functional teams to address non-conformances effectively. Utilize robust documentation and tracking tools to maintain process integrity and support audit readiness.
Supervise validation of equipment, processes, and methods
Supervise validation of equipment, processes, and methods to ensure compliance with industry standards and regulatory requirements. Oversee documentation review, develop validation protocols, and coordinate cross-functional teams to maintain quality assurance and operational efficiency. Implement corrective actions and continuous improvements based on validation outcomes to optimize manufacturing reliability.
Author and review SOPs, policies, and quality documentation
Responsible for authoring and reviewing SOPs, policies, and quality documentation to ensure compliance with industry standards and regulatory requirements. Collaborate with cross-functional teams to update and maintain accurate procedural guidelines that support operational excellence. Suggest continuous improvements to enhance clarity, effectiveness, and adherence to quality management systems.
Lead training programs on quality standards and protocols
Design and implement training programs focused on quality standards and protocols to ensure team proficiency and compliance. Evaluate training effectiveness through assessments and feedback to continuously improve educational materials. Collaborate with quality assurance and operational teams to align training content with industry regulations and organizational goals.
Monitor product quality and batch release
Ensure strict adherence to product quality standards by continuously monitoring manufacturing processes and conducting comprehensive quality control tests. Verify compliance with regulatory requirements prior to batch release to guarantee product safety and efficacy. Collaborate closely with production and quality assurance teams to promptly address any deviations or quality issues.
Liaise with regulatory agencies and prepare submissions
Coordinate with regulatory agencies to ensure compliance with industry standards and guidelines, facilitating timely and accurate submission of required documents. Prepare detailed regulatory submissions, including reports and applications, to support product approvals and ongoing compliance. Collaborate with internal teams to gather necessary data and address agency feedback effectively, ensuring smooth communication and adherence to regulatory timelines.
Analyze quality metrics and drive continuous improvement
Analyze key quality metrics such as defect rates, process efficiency, and customer satisfaction to identify trends and areas for improvement. Develop and implement targeted strategies to enhance product quality and operational processes, ensuring alignment with organizational goals. Collaborate with cross-functional teams to drive a culture of continuous improvement and achieve measurable performance gains.