Director/Associate Director - Clinical QA/GCP
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.
This is a unique opportunity to work at the intersection of genomics and therapeutics and participate in the development of a diverse therapeutic pipeline driven by a transformative core technology. The successful candidate will work well across multiple projects in a fast-paced and dynamic environment. This position will work closely with Clinical Operations, Translational, Supply Chain, MSAT, Regulatory, and Quality Assurance groups at Encoded Therapeutics to develop, implement, and manage clinical quality systems in accordance with GCPs/GLPs. This hands-on role will provide quality oversight to clinical operations, clinical trials, and any other clinical QA initiatives. The candidate will also be responsible for providing leadership to a growing clinical QA team inclusive of contractors/consultants.
- Provide leadership, strategy, and compliance oversight in accordance with Good Clinical Practices (GCPs), Good Clinical Laboratory Practices (GCLP), and Good Laboratory Practices (GLPs) for internal processes and Clinical Service Providers (Clinical Investigator Sites, Bioanalytical Laboratories, Data Management Vendors, e-Diary services, etc.)
- Develop, implement, and manage a risk-based quality governance and oversight program in compliance with GCP and GLP quality systems
- Partners with QA and Clinical Operations to develop, author, review, and/or approve clinical quality assurance SOPs
- Performs compliance review of clinical protocols, clinical study reports, investigator brochures, and any other clinical documentation
- Serves as QA representative and single point of contact on clinical study development teams. Provides interpretation of applicable regulations and guidelines.
- Conducts or supervises GLP and GCP training in accordance with global GCP standards
- Plans, schedules, and conducts GCP, GCLP, and/or GLP audits as lead auditor or co-auditor.
- Perform supplier risk assessments and evaluates for potential use; conduct and/or manage qualification audits of GCP suppliers and services
- Create and implement clinical study audit plans. Performs routine and/or for-cause audits as required
- Authors and issues audit reports, ensuring clear communication of audit findings and follows up on audit commitments
- Drives audit preparation activities for GCP or GCLP Health Authority inspections. Ensure successful outcomes and/or follow up and drive coordination of audit responses
- Manages and drives to completion all inspection commitments, post-inspection activities, and corrective and preventative actions in a timely manner
- Bachelor’ Degree in scientific or relevant disciplines in life sciences.
- 8+ years of combined hands-on experience in GCP QA and Clinical Operations in a regulated therapeutic/pharmaceutical environment
- 3+ years leading or managing a GCP function
- Demonstrated mastery of GCP, GLP, GCLP regulations and standards. GVP experience is a plus
- Solid understanding of applicable regulatory requirements (FDA CFR, EMA, ICH, ISO, GCP, any other global applicable laws and regulations). Working knowledge of ICH E6(R2) GCP guidelines
- Experience with GCP and GLP environments and audits (performing and receiving)
- Experience with Health Authority Inspections
- Experience with QA Quality Systems
- Significant procedure/protocol writing, revision, and reviewing experience
- Experience with IND and BLA submissions
- Strong interpersonal and communications skills; written and oral
- Outstanding planning, organization and multitasking skills
- Team player and exhibit a willingness to meet project timelines
- Travel as required
- Prior gene therapy experience is a plus
- 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
- Purple Tie dry cleaning service
- Fitness center
Encoded is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Encoded is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions at Encoded are based on business needs, job requirements and individual qualifications, without regard to race, religion or belief, color, national origin, gender, status as a protected veteran, status as an individual with a disability, or any other status protected by the laws or regulations in the location in which we operate. Encoded will not tolerate discrimination or harassment based on any of these characteristics. Encoded encourages applicants of all ages.
If you need assistance or an accommodation due to a disability, you may call us at +1 650-491-0272.