Sr. Director, Quality Operations

Scorpion Therapeutics; Winston-Salem (NC); On-site; USD 200,000 - 270,000; Full time

Job summary

Scorpion Therapeutics in Winston-Salem, NC seeks a Senior Director of Quality Operations to oversee GMP QA for clinical and commercial biologics manufacturing, focusing on aseptic and sterile product production on-site.

You will provide strategic and operational leadership across Manufacturing, Quality Control, and Warehouse, manage batch release, data integrity, investigations, CAPA, audit readiness, mentor staff, and lead cross-functional projects to enhance quality systems; ensure readiness

Qualifications

• Bachelor's in a scientific or health field.
• 10+ years of sterile manufacturing QA experience, particularly in biologics, cell, or gene therapy.
• Extensive GMP and regulatory knowledge.
• Proven leadership in high-performance QA teams.
• Strong understanding of aseptic processing, cleanroom operations, and regulatory inspections.

Responsibilities

• Lead Manufacturing, QA, and Warehouse to stay compliant with cGMP and global regs.
• Manage batch release, data integrity, investigations, CAPA, and audits.
• Mentor staff and drive cross-functional quality initiatives.
• Oversee risk assessments and change controls.

Job description

Role

Senior Director of Quality Operations overseeing GMP QA for ProKidney's clinical and commercial biologics manufacturing, focusing on aseptic, sterile product production.

Responsibilities

• provide strategic and operational leadership across Manufacturing, Quality Control, and Warehouse/Distribution to ensure compliance with cGMPs and global regulatory standards (FDA, EMA, ICH)
• manage batch release, data integrity, investigations, CAPA, and audit readiness
• mentor staff and lead cross-functional projects to enhance quality systems
• oversee risk assessments and change controls

Requirements

• Bachelor's in a scientific or health field
• 10+ years sterile manufacturing QA experience, particularly in biologics, cell, or gene therapy
• extensive GMP and regulatory knowledge
• proven leadership in high-performance QA teams
• strong understanding of aseptic processing, cleanroom operations, and regulatory inspections

High Value

• biologics
• cell/gene therapy
• sterile manufacturing
• GMP
• IND to commercialization transition
• FDA/EMA compliance
• investigation and CAPA management

Work Setup

not specified; likely on-site given manufacturing oversight.