Senior Manager of Technical QA (GMP)

Summit Therapeutics, Inc.; Palo Alto (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

Scorpion Therapeutics seeks a Senior Manager of Technical QA (GMP) to oversee quality compliance for oncology biologics, supporting process validation, tech transfer, lifecycle management, and post-approval changes.

The role requires 10+ years in pharma with biologics GMP experience, CMOs oversight, and readiness for regulatory submissions. On-site work is required 4 days/week in Palo Alto, CA (with potential alternates in Princeton, NJ).

Qualifications

• Bachelor’s in chemistry, biochemistry, chemical engineering, or related field.
• 10+ years in pharma with at least 5 years in biologics manufacturing, quality systems, and GMP compliance.
• Experience managing CMOs and analytical labs.
• Proficiency with regulatory filings (IND, BLA, MAA) and quality management systems like TrackWise.
• Strong knowledge of FDA, EMA, ICH regulations.

Responsibilities

• Provide GMP oversight for clinical and commercial manufacturing.
• Manage vendor quality performance.
• Lead change control processes.
• Review validation and comparability protocols.
• Support regulatory submissions.
• Ensure audit readiness.
• Collaborate with MSAT, Technical Operations, Supplier Quality and external partners to maintain compliance and drive continuous improvement.

Skills

GMP compliance

Quality systems

Vendor management

Regulatory submissions

Education

Bachelor’s degree in chemistry/biochemistry/chemical engineering or related field

Advanced degree (MS/PhD/PharmD) preferred

Tools

TrackWise

CMO management

Job description

Senior Manager of Technical QA (GMP)

Overseeing quality compliance across Summit’s oncology biologics portfolio, supporting process validation, technology transfer, lifecycle management, and post-approval changes.

Responsibilities

• Provide GMP oversight for clinical and commercial manufacturing
• Manage vendor quality performance
• Lead change control processes
• Review validation and comparability protocols
• Support regulatory submissions
• Ensure audit readiness
• Collaborate closely with MSAT, Technical Operations, Supplier Quality, and external partners to maintain compliance and drive continuous improvement

Requirements

• Bachelor’s in chemistry, biochemistry, chemical engineering, or related field
• 10+ years in pharma with at least 5 years in biologics manufacturing, quality systems, and GMP compliance
• Experience managing CMOs and analytical labs
• Proficiency with regulatory filings (IND, BLA, MAA) and quality management systems like TrackWise
• Strong knowledge of FDA, EMA, ICH regulations

Preferred

• Advanced degrees (MS, PhD, PharmD)
• Biologics experience
• International inspection support

High-Value

• Biologics, GMP manufacturing, process validation, change management, regulatory submissions, clinical to commercial lifecycle, global GMP compliance, US and international markets.

Work Setup

On-site 4 days/week in Palo Alto, CA or Princeton, NJ.