Manager, Clinical Quality Assurance

Summary

Join Encoded Therapeutics Inc., a biotechnology company focused on viral gene therapy, as a Manager, Clinical Quality Assurance. This remote position requires expertise in GCP and GLP to support clinical and non-clinical programs. You will oversee global clinical studies, establish QA programs, conduct audits, and ensure regulatory compliance. The ideal candidate possesses strong quality management experience in a clinical setting and a passion for clinical excellence. Responsibilities include providing CQA oversight, implementing risk-based quality approaches, and managing quality plans and metrics. The role also involves reviewing clinical documents, tracking deviations, and supporting inspection readiness activities.

Requirements

• Prior experience in the biotech, pharmaceutical, or CRO industry
• In-depth knowledge of GCP, GLP, ICH, and clinical trial operations
• Experience with GCP audits and/or regulatory inspections
• Strong organizational, communication, and problem-solving skills
• Ability to work independently and collaboratively in a fast-paced, dynamic environment
• 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
• Some travel may be required (up to 20%)
• Bachelor’s degree in life sciences or a related field (advanced degree preferred). A manager typically requires a minimum of 8 years of related experience with a bachelor’s degree; or 6 years and a master’s degree. A senior manager typically requires a minimum of 12 years of related experience with a bachelor’s degree; or 8 years and master’s degree

Responsibilities

• Provide CQA oversight to global clinical studies to ensure study conduct compliance in accordance with GCP, applicable regulatory requirements, study protocols and procedures
• Establish, maintain and enhance GCP QA programs, policies, and procedures
• Support the implementation of risk-based quality approaches in clinical trial activities and procedures
• Design and implement the creation/management/maintenance of quality plans and metrics
• Manage and/or conduct internal and external quality audits of clinical vendors and investigator sites
• Facilitate and support inspection readiness activities including collaborating with cross functional and clinical site Inspection Readiness/Preparedness activities
• Perform quality review of key clinical documents (e.g. clinical protocols, ICF, IBs, etc.) and clinical SOPs
• Track and support the resolution of GCP deviations, CAPAs, and quality events
• Support clinical service provider selection and qualification activities and periodic compliance/metric reports
• Review of vendor quality agreements as applicable
• Support GCP training program as needed
• Represent CQA in assigned projects and study/program team meetings to address quality issues that may arise, including identification and resolution and be an advocate for quality and regulatory compliance
• Accountable for QA review of non-clinical and clinical trial documentation, and documents submitted to regulatory agencies
• Perform other duties and projects as assigned by management

Preferred Qualifications

Experience in rare disease or neuroscience-related clinical trials a plus

Benefits

• A hired applicant may be eligible for an annual bonus as well as equity under the company’s stock plan
• Comprehensive benefits package, including competitive employer premium contributions
• Meaningful stock option grants
• PTO, sick time, and holiday pay
• Generous Parental Leave program
• Pre-tax medical and dependent care programs
• STD, LTD, Life and AD&D
• Professional development opportunities
• Team-building events
• Fully stocked kitchen
• Employees (and their families) may obtain medical, dental, vision and basic life insurance benefits through the company and enroll in our company's 401k plan
• Employees will also accrue vacation time off and paid sick time off and may become eligible for paid parental leave
• Employees will also enjoy designated paid holidays throughout the calendar year