Sr. Manager, Quality Science & Technology (CDx)

Scorpion Therapeutics; Carpinteria (CA); On-site; USD 137,000 - 213,000; Full time

Job summary

Scorpion Therapeutics in California is seeking a Lead Design Quality Manager for Companion Diagnostics (CDx) to oversee design assurance, risk management, and compliance activities across the portfolio.

You will lead a team, ensure adherence to design controls, support regulatory interactions, and maintain the QMS, collaborating with pharma partners to drive quality excellence and continuous improvement in a regulated environment.

Qualifications

• Bachelor's or master's degree in a relevant field.
• 2+ years of leadership experience in quality within regulated industries.
• Strong knowledge of medical device standards and IVD regulations.

Responsibilities

• Lead a team ensuring quality oversight of development processes.
• Ensure adherence to design controls and maintain the QMS.
• Support regulatory interactions and compliance activities.
• Collaborate with pharma partners and internal stakeholders.
• Provide expertise in ISO13485, FDA CFR 21 Part 820, and IVDR.
• Drive continuous improvement and risk-based quality management.

Skills

Leadership

Quality oversight

Regulatory compliance

Risk management

Cross-functional collaboration

Education

Bachelor's or Master's in a relevant field

Job description

Lead Design Quality Management for Companion Diagnostics (CDx)

overseeing design assurance, risk management, and compliance activities across the portfolio.

Responsibilities

manage a team supporting quality oversight of development processes, ensure adherence to design controls, support regulatory interactions, and maintain the Quality Management System (QMS). Collaborate with internal and external stakeholders, including pharma partners, to drive quality excellence and continuous improvement. Provide expertise in implementing regulations like ISO13485, FDA CFR 21 Part 820, and IVDR, ensuring product safety and regulatory compliance.

Qualifications

Bachelor's or Master’s in a relevant field, 2+ years’ leadership experience in quality within regulated industries, with strong knowledge of medical device standards and IVD regulations.

Preferred

experience in pharmaceutical or medical device industry, particularly in IVD/biotech settings. High-Value: focus on diagnostic device design, regulatory compliance, risk management, GxP, and cross-functional collaboration in a regulated environment.

Work Setup

Full-time, day shift, with occasional travel; salary range $136,618-$213,465, plus bonus and benefits.