Senior Manager, CMC QA

Scorpion Therapeutics; Brisbane (CA); Hybrid; USD 140,000 - 190,000; Full time

Job summary

Scorpion Therapeutics Senior Manager, CMC QA oversees Product Complaints, Annual Product Quality Review, and Change Control programs within biopharmaceutical manufacturing.

Maintain regulatory compliance with FDA/EMA/ICH, lead global quality review processes, support product release, and drive continuous improvement across operations in a hybrid onsite role with up to 10% travel.

Qualifications

• Bachelor’s degree or equivalent in QA/manufacturing.
• 8+ years’ GMP biopharma experience in technical operations or quality.
• Experience with change control management and product disposition.
• Knowledge of EMA, ANVISA, MHRA and FDA expectations; product complaint investigations preferred.
• Experience with GMP standards, quality systems, and cross-functional collaboration.

Responsibilities

• Lead global quality review processes.
• Manage change control review board.
• Support product release and investigate quality events.
• Facilitate audits/inspections.
• Drive continuous improvement initiatives.
• Develop and review CMC QA standards and procedures to ensure regulatory compliance with FDA, EMA, and other authorities, including ICH guidelines.

Skills

GMP Biopharma

Change control management

Quality systems

Cross-functional collaboration

Product disposition

Education

Bachelor’s degree in QA/manufacturing

Job description

Role:

Senior Manager, CMC QA overseeing Product Complaints, Annual Product Quality Review, and Change Control programs within biopharmaceutical manufacturing.

Objectives:

Maintain strategic direction for QA manufacturing operations, ensuring compliance with GxP regulations and Ultragenyx standards.

Responsibilities:

• Lead global quality review processes
• manage change control review board
• support product release and investigate quality events
• facilitate audits/inspections
• drive continuous improvement initiatives
• Develop and review CMC QA standards and procedures, ensuring regulatory compliance with FDA, EMA, and other authorities, including ICH guidelines.

Requirements:

• Bachelor’s degree or equivalent in QA/manufacturing, with 8+ years’ GMP biopharma experience in technical operations or quality, including change control management and product disposition.
• Knowledge of regulatory expectations beyond FDA, such as EMA, ANVISA, and MHRA, and familiarity with product complaint investigations is preferred.
• Experience with GMP standards, quality systems, and cross-functional collaboration in manufacturing environments.

Work setup:

Hybrid onsite role (2-3 days/week), with up to 10% travel.