Salary Range: 75000 to 105000 (Currency: USD) (Pay period: per-year-salary)

Responsibilities

• Quality System Management:
• Oversee the management of quality systems including deviations, change controls, CAPAs, and document control.
• Ensure that all deviations are investigated thoroughly and timely, identifying root causes and implementing effective corrective actions.
• Review and approve change controls to ensure compliance with regulatory requirements and internal procedures.
• Maintain and improve CAPA processes to ensure effective resolution of quality issues.
• Batch Disposition:
• Evaluate batch records and associated documentation to make informed batch release decisions.
• Collaborate with manufacturing and quality control teams to ensure all products meet regulatory and quality standards before release.
• Monitor and document any quality issues related to batch production and implement corrective measures as necessary.
• Document Management:
• Maintain the document management system to ensure all quality-related documents are accurate, current, and compliant with regulatory standards.
• Conduct regular reviews of quality documentation to ensure adherence to established protocols and procedures.
• Regulatory Compliance:
• Stay informed of current regulations, industry trends, and best practices in pharmaceutical quality assurance.
• Assist in preparing for internal and external audits, ensuring that all quality systems and documentation are audit-ready.
• Training and Support:
• Provide training and guidance to staff on quality systems, processes, and compliance requirements.
• Serve as a point of contact for quality-related inquiries and issues, fostering a culture of quality within the organization.
• Continuous Improvement:
• Participate in continuous improvement initiatives to enhance the effectiveness and efficiency of quality systems and processes.
• Identify areas for improvement within quality operations and suggest appropriate solutions.
• Track completion of quality records and maintain metrics.
• Perform other duties as requested by supervisor/manager to support Quality
• Work collaboratively with cross-functional teams, including manufacturing, research and development, and quality assurance, to support the overall quality of cell therapy products.

General Requirements

• Communicate effectively with team members and contribute to a positive and collaborative work environment
• Actively participate in group and project teamwork; project and process improvements
• Strong organizational skills and the ability to manage multiple tasks concurrently
• Willingness to learn and adapt in a fast-paced, dynamic environment
• Adhere to cGMP policies and procedures, including documentation activities
• Able to wear appropriate personal protective equipment
• Willingness to work overtime as required

Experienced Required

• Bachelor’s degree in a relevant scientific discipline (biology, biochemistry, immunology, etc.) with 5+ years of experience in quality control testing, analytical development, or GMP; OR a Master’s degree in relevant scientific disciplines with 3+ years of experience
• Understanding of FDA regulations, GMP compliance, and quality system processes
• Experience in quality control or GMP within a cell therapy or biopharmaceutical manufacturing environment is preferred
• Able to meet project and testing timelines
• Detail-oriented with a commitment to data integrity and accuracy, and an ability to identify problems with data management
• Able to work collaboratively to respond to changing priorities and challenges
• Ability to work both independently and collaboratively with a multi-disciplinary team in a fast-paced and regulated environment
• Prior experience doing internal audits and document control management