Senior Manager, CMC QA

Scorpion Therapeutics; Bedford (MA); Hybrid; USD 140,000 - 180,000; Full time

Job summary

Scorpion Therapeutics is seeking a Senior Manager, CMC QA to oversee Product Complaints, Annual Product Quality Review, and Change Control Review Board programs within biopharmaceutical manufacturing, ensuring GxP compliance.

The role leads global quality review processes, supports product release, investigates complaints, and represents the organization during regulatory inspections. Hybrid work with 2-3 onsite days weekly and up to 10% travel.

Qualifications

• Bachelor's degree or equivalent in QA or related field.
• 8+ years GMP biopharma experience in technical operations and quality.
• Experience with Change Control and Product Disposition.

Responsibilities

• Oversee global quality review processes and change control activities.
• Support product release and investigate product complaints.
• Represent the organization during regulatory inspections.

Skills

GxP knowledge

Change Control

Product Disposition

Regulatory inspections

Education

Bachelor's degree in QA or related field

Job description

Role

Senior Manager, CMC QA responsible for overseeing Product Complaints, Annual Product Quality Review, and Change Control Review Board programs within biopharmaceutical manufacturing, ensuring compliance with GxP regulations.

Responsibilities

Leading global quality review processes, managing change control activities, supporting product release, driving continuous improvement initiatives, developing QA standards, investigating product complaints, and representing Ultragenyx during regulatory inspections.

Qualifications

Bachelor's degree or equivalent in QA or related field; 8+ years of GMP biopharma experience in technical operations and quality, with expertise in Change Control and Product Disposition.

Preferred Skills

Experience with regulatory authorities (FDA, EMA, etc.), strong knowledge of GMPs, and familiarity with product complaint investigations.

High-Value

Focus on biopharma with an emphasis on rare disease products, GxP compliance, and cross-functional collaboration in quality and manufacturing.

Work Setup

Hybrid model requiring 2-3 onsite days weekly; up to 10% travel.