Established Search · 16 hours ago
Quality Assurance Manager
United States
Full-time
Remote
Senior Level
6+ years expEstablished Search is a growing radiopharmaceutical manufacturing organization seeking a Quality Assurance Manager to oversee GMP quality activities across multiple contract manufacturing sites in the Houston area. This role involves leading FDA inspections, establishing QA processes, and providing on-the-floor QA support to ensure compliance and drive continuous improvement.
Staffing & Recruiting
Hiring Manager
Sam Powell
Responsibilities
Lead and support FDA inspections, client audits, and inspection readiness activities
Establish and maintain QA processes, documentation, and systems supporting GMP manufacturing
Review and approve key GMP deliverables including batch records, stability data, CoAs, and material releases
Oversee product complaints and Annual Product Quality Reviews, using trend analysis to drive continuous improvement
Act as a primary quality contact for external partners and clients, ensuring expectations are clearly defined and met
Provide on-the-floor QA support to help manufacturing teams identify and resolve compliance issues in real time
Support quality input into regulatory submissions and project documentation
Partner with Quality Control and Manufacturing teams to ensure seamless execution
Coach and develop QA team members while fostering a strong quality culture
Contribute to inspection readiness programs, mitigation plans, and internal audits
Drive operational excellence initiatives, knowledge management, and process improvements
Qualification
Required
Bachelor's degree in a scientific discipline (Chemistry, Biology, or related)
6–10 years of Quality Assurance experience in GMP manufacturing environments
Strong working knowledge of 21 CFR Part 211 and international GMP/ICH expectations
Experience supporting FDA inspections and customer audits
Proven ability to work independently while collaborating across multidisciplinary teams
Excellent organizational, communication, and problem-solving skills
High attention to detail with confidence reviewing complex technical documentation
Preferred
Background in radiopharmaceuticals, radioligand therapy, or sterile pharmaceutical manufacturing
CQA or similar quality certifications are a plus
Company
Established Search
Established Search is a global executive search firm focused on providing talent solutions across a broad range of job functions.
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase