Senior Manager, Quality Validation

Scorpion Therapeutics; California (MO); On-site; USD 164,000 - 205,000; Full time

Benefits offered by this job

Equity

Development opportunities

Job summary

Scorpion Therapeutics, a late-stage oncology biopharma, seeks a Senior Manager, Quality Validation to oversee commercial manufacturing validation activities. The role focuses on PPQ and CPV, liaising with CMOs for drug substance, drug product, and packaging.

You will drive compliance with global GMP standards and support regulatory readiness. Responsibilities include reviewing validation plans and risk assessments, monitoring metrics, and guiding investigations and change controls to ensure a

Qualifications

• 8+ years in GMP pharmaceutical quality and manufacturing.
• Proven experience in validation lifecycle, especially PPQ and CPV.
• Knowledge of process validation principles and global GMP regulations.
• Experience supporting commercial product lifecycle.

Responsibilities

• Oversee validation activities including PPQ and CPV across CMOs for drug substance, product, and packaging.
• Review validation plans, reports, and risk assessments.
• Ensure compliance with global GMP standards.
• Support GMP operations, deviations, investigations, and change controls.
• Monitor validation metrics and assist regulatory inspection readiness.

Skills

Validation lifecycle

GMP knowledge

Regulatory compliance

Cross-functional collaboration

Education

Bachelor's degree in science/engineering/technical field

Job description

Role: Senior Manager, Quality Validation at a late-stage oncology biopharma developing RAS-targeted therapies, focusing on validation oversight for commercial manufacturing.

Responsibilities

• oversee validation activities including PPQ and CPV across external CMOs supporting drug substance, drug product, and packaging;
• review validation plans, reports, and risk assessments;
• ensure compliance with global GMP standards;
• support GMP operations, deviations, investigations, and change controls;
• monitor validation metrics and assist regulatory inspection readiness.

Requirements

• Bachelor's in science, engineering, or technical field;
• 8+ years in GMP pharmaceutical quality and manufacturing;
• proven experience in validation lifecycle, especially PPQ and CPV;
• knowledge of process validation principles, global GMP regulations, and experience supporting commercial product lifecycle.

Preferred

• experience with oral solid dosage forms;
• lifecycle management across multiple CMOs;
• statistical trending;
• post-approval activities.

Additional Information

• High-value specifics: focus on commercial validation, validation of manufacturing, packaging, and transportation, with a regulatory compliance emphasis.
• Collaboration with internal teams and external manufacturing partners, reporting to Quality leadership.
• Work setup: onsite at Redwood City, CA, with a salary range of $164,000 to $205,000; benefits and total rewards include equity and development opportunities.