Senior Manager, Quality Assurance Vendor & Audit Management

Scorpion Therapeutics; Boston (MA); Hybrid; USD 150,000 - 190,000; Full time

Benefits offered by this job

Hybrid onsite in Somerville, MA

Job summary

Scorpion Therapeutics in Somerville, MA is seeking a Senior Manager, QA Compliance to oversee vendor qualification, supplier oversight, and GxP audit programs within a cell & gene therapy biotech.

You will lead qualification, approval, and monitoring of GxP vendors (CMOs, CROs, labs, logistics); develop risk-based audit strategies; support regulatory inspections and quality agreements; drive continual quality improvements; mentor QA staff.

Qualifications

• 8–10+ years in QA, compliance, or auditing within biotech, cell & gene therapy, or pharmaceuticals.
• Extensive GxP audit and vendor qualification experience.
• Track record supporting regulatory inspections.

Responsibilities

• Lead qualification, approval, and monitoring of GxP vendors (CMOs, CROs, laboratories, logistics).
• Develop risk-based audit strategies and manage internal/external audits.
• Oversee vendor performance metrics and support quality agreements.

Skills

Leadership

Quality mindset

Communication

GxP auditing

Education

Bachelor's in Life Sciences, Pharmacy, or related

Job description

Role

Senior Manager, QA Compliance overseeing vendor qualification, supplier oversight, and GxP audit programs within a cell & gene therapy biotech.

Responsibilities

lead qualification, approval, and monitoring of GxP vendors (CMOs, CROs, laboratories, logistics); develop risk-based audit strategies; manage internal and external audits; oversee vendor performance metrics; support quality agreements and regulatory inspection readiness; drive continuous quality improvements; mentor QA team members.

Requirements

Bachelor's in Life Sciences, Pharmacy, or related; 8-10+ years in QA, compliance, or auditing within biotech, cell & gene therapy, or pharmaceuticals; extensive GxP audit and vendor qualification experience; track record supporting regulatory inspections.

HighValue

expertise in GxP vendor audits, vendor management, and supplier quality in biotech; familiarity with FDA, EMA regulations; leadership in a regulated environment; hybrid onsite in Somerville, MA with some travel.