QA Director, Regenerative Organ Manufacturing

Scorpion Therapeutics; Chapel Hill (NC); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

401(k) and ESPP

Paid time off

Paid parental leave

Disability benefits

Job summary

Scorpion Therapeutics in North Carolina seeks a Senior QA leader to provide strategic and operational leadership for Quality Assurance for the RMOMAL regenerative organ manufacturing program from Pre-IND through commercialization.

You will build and execute a phase-appropriate QMS, manage the QA/QC team, oversee audits and CAPAs, ensure data integrity and regulatory readiness, and collaborate with regulatory, manufacturing, and supply partners to drive IND-enabling milestones.

Qualifications

• Bachelor’s degree in a technical/scientific field with 12+ years of related experience (or 10+ years with a Master’s).
• 6+ years of people management experience.
• Experience contributing to IND/BLA for cell/tissue-based regenerative medicine.
• Applied cGMP/cGTP/QSR/FDA knowledge and GxP applications to novel modalities.
• Experience with MCB generation, aseptic process simulation or cell banking QA oversight.
• Proven track record building/implementing a QMS in Pre-IND or early clinical environments.
• Experience negotiating Quality Agreements and Manufacturing/Supply Agreements with CMOs and labs.
• Strong risk assessment, analytical judgement, and problem-solving abilities.

Responsibilities

• Provide strategic and operational QA leadership for RMOMAL from Pre-IND through commercialization.
• Develop QA strategy and translate into operational plans for RMOMAL QA/QC.
• Lead phase-appropriate QMS build-out and IND-readiness initiatives.
• Serve as QA representative for IND-enabling gap assessments and regulatory interactions.
• Oversee budgeting, staffing, and expenses for RMOMAL QA.
• Lead and develop the RMOMAL QA/QC team.
• Maintain compliance with data integrity and GMP/cGTP/QSR/Trial requirements.
• Oversee deviations, CAPA, change control, QC testing, and product quality reviews.

Skills

QA leadership

GMP/GxP

Regulatory compliance

Quality systems

IND/CMO coordination

Education

Bachelor's degree in technical/scientific field

Tools

TrackWise

MasterControl

LIMS

Job description

Scorpion Therapeutics in North Carolina seeks a Senior QA leader to provide strategic and operational leadership for Quality Assurance for the RMOMAL regenerative organ manufacturing program from Pre-IND through commercialization.

You will build and execute a phase-appropriate QMS, manage the QA/QC team, oversee audits and CAPAs, ensure data integrity and regulatory readiness, and collaborate with regulatory, manufacturing, and supply partners to drive IND-enabling milestones.