Specialist, Quality Systems

This position is part of the Quality Assurance group and will be responsible for supporting the company’s quality management systems (QMS) strategies and quality oversight of internal GMP manufacturing activities. Monitor, review and approve Change Controls, Deviations, CAPAs, and Lab Investigations related to the implementation or revision of process, assay qualifications, methods, and/or equipment changes.

Seeking a Specialist, Quality Systems to provide Quality Assurance support for early-stage gene therapy candidates. This position is part of the Quality Assurance group and will be responsible for supporting the company’s quality management systems (QMS) strategies and quality oversight of internal GMP manufacturing activities.

Responsibilities:

• Represent QA in cross-functional team meetings; provides guidance and recommendations in alignment with SOPs and regulatory requirements.
• Maintain updated and relevant knowledge of the GxP landscape, regulations, and guidelines.
• Assist in the development, implementation, and continuous improvement of various quality systems, policies, and procedures.
• Assist in the implementation and management of the company’s electronic Quality Management systems (Veeva QMS) and additional systems as determined. 
• Author and revise QA related standard operating procedures, and provide QA guidance for the generation, review, and approval of process, equipment, analytical equipment, test method, and other SOPs.
• Collaborate with cross-functional teams to define and monitor the GxP training curriculum.
• Support the effective execution of the Risk Management Program.
• Assist with supplier management including Supplier Change Notification and Qualification of suppliers and service providers for GxP-related activities.
• Support laboratory quality activities for analytical sciences and operations.
• Monitor, review and approve Change Controls, Deviations, CAPAs, and Lab Investigations related to the implementation or revision of process, assay qualifications, methods, and/or equipment changes. 
• Manage and coordinate external and internal audits.
• Manage and maintain QA logs, logbooks, databases, etc.
• Maintain equipment files, approve IQ/OQ/PQ protocol and reports, and ensure all applicable documentation is archived.
• Support the QA review of all internal GMP related documentation (protocols, technical reports, QC data, batch records, etc.) for compliance with established procedures, standards, and regulations.
• Perform other duties and projects as assigned by management. 

 
Requirements /Qualifications:

• Bachelor’s Degree in relevant disciplines in life sciences
• 5+ years of QA experience in a pharmaceutical or therapeutic environment
• GMP experience (GMP, GLP, GDP, etc.)
• Experience and understanding of applicable regulatory requirements and guidance documents (21 CFR, USP, EP, ICH).
• Ability to thrive in a fast-paced dynamic environment with the ability to maintain objective and autonomous as it relates to quality and compliance.
• Demonstrated knowledge of quality management systems, processes, and procedures.
• Strong interpersonal and communications skills; written and oral.
• Outstanding planning, organization and multitasking skills.
• Must be a team player and exhibit a willingness to meet project timelines.
• Extremely high degree of attention to detail.
• Strong documentation skills.
• Responsible and accountable with non-compromising high ethical standards.
• Ability to translate complex issues into meaningful recommendations.

Preferred Qualifications:

• Experience with electronic DMS/LMS/QMS software platforms (Prior experience with Veeva systems is a plus.)
• Experience supporting IND and BLA submissions or support
• Strong interpersonal and communications skills; written and oral
• Outstanding planning, organization, and multitasking skills.
• Prior gene therapy experience is a plus.
• Experience with Supplier Quality Management
• Experience with Equipment, Software, and Test Method Validation
• Experience with AAV or gene therapies