Senior Manager, Clinical Quality Assurance (Contract)

Kriya Therapeutics; North Carolina; Presencial; USD 140.000 - 170.000; Jornada completa

Descripción de la vacante

Kriya Therapeutics, Inc. is seeking a Senior Manager, Clinical Quality Assurance (Contract) to ensure audit-ready clinical trials. You will own GCP training, SOP standards, and the DOT eQMS Clinical module while providing QA oversight of CROs, vendors, and quality events across trials.

You will lead documentation reviews, drive CAPA programs, and partner with clinical teams to uphold global regulatory requirements and high-quality trial conduct.

Formación

• Bachelor’s degree in a scientific field; advanced degree preferred.
• Strong knowledge of GCP, ICH guidelines, and FDA regulations.
• Experience with Quality Management Systems (QMS) and SOP development.
• Exposure to audits, CAPAs, and inspection readiness activities.

Responsabilidades

• Review and oversee clinical QA documentation including SOPs, protocols, ICFs, reports, and study documents.
• Collaborate with Clinical Operations to maintain GCP compliance and internal procedures.
• Perform quality assessments of clinical processes, documentation, and outputs.
• Maintain documentation of quality activities, deviations, CAPAs, and quality events.
• Lead audits of CROs, vendors, and investigator sites; manage vendor qualification.

Conocimientos

GCP knowledge

ICH guidelines

FDA regulations

QMS experience

SOP development

Audit readiness

Communication skills

Problem solving

Educación

Bachelor’s degree in a scientific discipline

Advanced degree preferred

Descripción del empleo

Senior Manager, Clinical Quality Assurance (Contract)

Department: Quality Assurance

Employment Type: Contract

Location: Research Triangle Park, NC

Description

Kriya is a biopharmaceutical company whose mission is to develop life-changing gene therapies for diseases affecting millions of patients around the world.
We leverage our proprietary computational engine, in-house manufacturing infrastructure, and integrated design platform to engineer technologies and therapeutics with the potential to transform the treatment of a broad universe of diseases of high unmet need, with a focus on metabolic disorders, neurology, and ophthalmology.
We are proud to have been named Triangle Business Journal’s Life Sciences 2024 “Best Private Company to Work For,” recognized by Forbes as one of “America’s Best Startup Employers of 2024,” and honored as one of BioSpace’s “2025 Best Places to Work.”

Role Overview

The Sr. Manager, Clinical Quality Assurance (contract) is an internal expert on how GCP, ICH, and global regulatory requirements are applied across Kriya’s QMS, owning the standards, training, and oversight that keep clinical trial activities audit-ready. This role sets the approach on Clinical SOPs, the DOT eQMS Clinical module, and GCP training, and provides QA oversight of CROs, vendors, and quality events throughout trial conduct.

Key Responsibilities

• Review and provide oversight of clinical QA documentation including SOPs, protocols, ICFs, reports, and study-level documents
• Collaborate with Clinical Operations teams in maintaining compliance with GCP, ICH, and internal procedures
• Perform quality assessments on clinical processes, documentation, and outputs
• Maintain accurate documentation of quality activities, including deviations, CAPAs, and quality events
• Apply expertise to define standards for SOP development, revision, and implementation
• Serve as a QA subject matter expert for assigned clinical studies or programs
• Provide proactive quality guidance to study teams, identifying risks and leading mitigation strategies
• Lead audits of CROs, vendors, and investigator sites
• Oversee vendor qualification and oversight activities
• Ensure audit findings are tracked and addressed appropriately
• Own investigation of quality events and deviations
• Drive root cause analysis and CAPA development
• Track CAPAs and coordinate timely closure
• Provide expertise for inspection readiness activities (e.g., document review, gap assessments, back-room support)
• Partner with Clinical Operations and other functions to support quality across clinical programs
• Spearhead development of tools, templates, and quality metrics
• Contribute to continuous improvement initiatives within the QMS

Experience & Skills and Work Environment

Experience & Skills

• Bachelor’s degree in a scientific or related discipline (advanced degree preferred)
• 7–10 years of experience in clinical quality and/or clinical operations in a biotech, pharmaceutical, or CRO environment
• Experience in gene therapy, biologics, or advanced therapeutics strongly preferred
• Strong knowledge of GCP, ICH guidelines, FDA regulations, and global regulatory requirements
• Experience with Quality Management Systems (QMS) and SOP development
• Exposure to audits, CAPAs, and inspection readiness activities
• Ability to work independently while operating effectively in a collaborative environment
• Strong problem-solving and critical thinking skills
• Excellent communication and interpersonal skills
• High level of organization and ability to manage multiple priorities
• Willingness to take on increasing responsibility and ownership

Work Environment

• Remote or hybrid (as applicable)
• Work is normally performed: at a desk
• Lifting requirements: Under 20 lbs
• Travel requirements: Occasional
• Must be willing to work outside of normal business hours, as necessary, to support the clinical project team members on different time zones.

Life at Kriya

Discover True Collaborative Teamwork

We have an ambitious set of goals, but our confidence – and our inspiration – stems from our people. From California to North Carolina, our teammates bring a spirit of Collaboration, Leadership, and Innovation to their work every day.

We’re always looking for teammates with the drive and energy to help us grow. If you want to be a part of a company with an entrepreneurial culture, a bold vision, and a meaningful purpose, join us.