Manager, Clinical Quality Assurance

Encoded Therapeutics Inc. is a biotechnology company advancing precision medicines for a broad range of genetic disorders. Our mission is to unlock new opportunities for viral gene therapy through genomics-driven discovery. We focus on delivering life-changing advances for individuals with genetic disorders not addressable with current approaches. For more information, please visit www.Encoded.com.

Position details

We are seeking a detail-oriented and proactive Manager, Clinical Quality Assurance with expertise in Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) to support our clinical development programs as well as support the non-clinical team on GLP studies. The ideal candidate will have a strong background in quality management within a clinical setting and a passion for maintaining the highest standards of clinical excellence.

Workplace Model: Remote

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

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

For candidates based in the SF Bay Area, the anticipated salary range for the Manager, Clinical Quality Assurance role is 130,000.00 - 152,000.00. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type, length of experience within the industry, education, etc. Encoded Therapeutics is a multi-state employer and this salary range may not reflect positions that work in other states.

A hired applicant may be eligible for an annual bonus as well as equity under the company’s stock plan.

Benefits

• Comprehensive benefits package, including competitive employer premium contributions
• Meaningful stock option grants