Biologics QA Director — Build Quality from Ground Up

Discover International; North Carolina; On-site; USD 180,000 - 260,000; Full time

Job summary

Discover International seeks an experienced, hands-on Director of Quality Assurance to establish and lead the biologics quality function from the ground up in a fast-paced startup environment. You will design a phase-appropriate QMS, host inspections, and drive data integrity and supplier qualification across drug substance, drug product, and device-like components.

You will serve as the primary quality leader, author SOPs, manage audits/CAPAs, and partner with CMC/Regulatory to enable tech

Qualifications

• Bachelor’s degree in scientific/technical field; advanced degree preferred.
• 15+ years of progressive QA experience in biotech/pharma, including Director level.
• Hands-on experience building/rolling out a QMS (SOPs, document control, deviations/CAPA, change control, training).
• Proven biologics manufacturing quality oversight experience.
• CDMO manufacturing experience.
• Experience hosting/regulatory inspections and managing audit programs.
• Experience in startup/small‑company environments and building cross‑functional processes.
• Strong GMP knowledge; GLP preferred.
• Experience with drug substance and drug product QA oversight.
• Excellent written and verbal communication; able to author/review technical documents.
• Strong leadership and ability to operate independently while building consensus.

Responsibilities

• Design, implement, and continuously improve a right-sized QMS for an early-stage company.
• Establish core quality infrastructure: document control, deviations/CAPA, change control, training, vendor qualification.
• Serve as primary quality leader and champion a culture of quality across functions.
• Author, review, and maintain SOPs, quality policies, and controlled documents.
• Ensure regulatory-ready documentation and data integrity (ALCOA+).
• Develop and execute internal and external (CDMO) audit programs; conduct audits as needed.
• Lead inspection readiness and host FDA/health authority inspections when required.
• Manage audit findings, CAPAs, and closure activities.
• Provide QA oversight of drug substance/product manufacturing, testing, and release.
• Review and approve batch records, COAs, specifications, and GMP docs.
• Partner on tech transfer, process validation, and comparability protocols.
• Oversee raw materials and supplier qualifications; manage material release processes.
• Negotiate quality agreements with CDMOs and labs; support regulatory submissions.
• Support device/combination product QA where applicable (design controls, risk management).
• Build and lead the QA function, including hiring/contractor management.
• Embed quality thinking across development with CMC, Regulatory, and leadership.
• Report quality metrics, risks, and inspection readiness to executive leadership/Board.

Skills

Quality leadership

QMS design

GxP compliance

Biologics quality

Regulatory inspections

Vendor/CDMO management

Auditing

Cross-functional collaboration

Education

Bachelor's degree in science

Advanced degree preferred

Job description

Discover International seeks an experienced, hands-on Director of Quality Assurance to establish and lead the biologics quality function from the ground up in a fast-paced startup environment. You will design a phase-appropriate QMS, host inspections, and drive data integrity and supplier qualification across drug substance, drug product, and device-like components.

You will serve as the primary quality leader, author SOPs, manage audits/CAPAs, and partner with CMC/Regulatory to enable tech