Senior Manager, CMC QA
Job in
Brisbane, San Mateo County, California, 94005, USA
Listed on 2026-09-14
Listing for:
Scorpion Therapeutics
Full Time, Part Time
position Listed on 2026-09-14
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist, QA Specialist - Analyst/Manager, Quality Engineering
Job Description & How to Apply Below
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.
- 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.
Hybrid onsite role (2-3 days/week), with up to 10% travel.
Position Requirements
10+ Years
work experience
To View & Apply for jobs on this site that accept applications from your location or country, tap the button below to make a Search.
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
Search for further Jobs Here:
×