Sr. Manager, Quality Assurance for Quality Control

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

Job summary

Scorpion Therapeutics seeks a Senior Manager of Quality Assurance for Quality Control to oversee contract testing organizations for in-process, release testing of raw materials, starting materials, and drug products supporting commercial operations.

The role leads quality systems, manages deviations and CAPAs, and collaborates with CTOs/CMOs to ensure timely issue resolution while supporting cGMP testing and documentation in a hybrid setup in Somerville, MA.

Qualifications

• BS/MS in a scientific discipline.
• 5+ years of experience in QC CGMP environments.
• Experience managing CTOs/CMOs.
• Stability program management experience.
• Familiarity with ICH, FDA, EMA regulations.

Responsibilities

• manage quality systems (deviations, investigations, CAPAs)
• lead stability program including data management and regulatory support
• build relationships with CTOs/CMOs to ensure timely issue resolution
• support cGMP routine testing and documentation

Skills

QC in cGMP environments

CTOs/CMOs interfacing

Stability program management

Regulatory knowledge ICH/FDA/EMA

Education

BS/MS in a scientific discipline

Job description

Role:

Senior Manager, Quality Assurance for Quality Control at a biopharma company specializing in gene therapies, overseeing contract testing organizations for in-process and release testing of raw materials, starting materials, and drug products supporting commercial operations.

Responsibilities:

• manage quality systems (deviations, investigations, CAPAs)
• lead stability program including data management and regulatory support
• build relationships with CTOs/CMOs to ensure timely issue resolution
• support cGMP routine testing and documentation

Requirements:

• BS/MS in a scientific discipline
• 5+ years in QC cGMP environments
• experience managing CTOs/CMOs
• stability program management
• familiarity with ICH, FDA, EMA regulations

High-Value:

• biologics/gene therapy modalities
• commercial phase
• cGMP compliance
• stability testing
• contract manufacturing interfaces
• regulatory documentation
• cross-functional collaboration

Work Setup:

hybrid in Somerville, MA.