Senior Quality Manager

🕒 April 28

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Cristcot

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2008

💊 Pharmaceuticals

🔬 Science

💰 $10.5M Venture Round - Cristcot on 2025-06

Pharmaceuticals • Science

Cristcot is a pharmaceutical development and research company specializing in innovative drug formulations and unobtrusive drug-device combination technologies designed to improve patient adherence, reduce treatment burden, and integrate therapies into daily life. Founded in 2008 and headquartered in Austin, Texas, Cristcot provides clinical research design and execution, novel formulation and delivery engineering, specialized assay development, and regulatory strategy support; its lead investigational therapy has completed a pivotal Phase 3 study. The company focuses on solving overlooked barriers in disease management by creating intuitive, cost-effective solutions that enable more effective and confident care.

📋 Description

• Lead and manage the Quality department, including hiring, training, and performance management • Ensure compliance with cGMP, FDA, EMA, ISO 13485 and other global regulatory requirements • Oversee quality systems including CAPA, deviations, change control, and document management • Function as the primary quality interface with CDMOs and testing labs. • Drive inspection readiness and lead internal audits • Review and approve batch records, SOPs, change controls, methods, specifications, protocols and reports, and quality-related documentation • Collaborate with cross-functional teams to support product development and commercialization • Manage supplier quality and oversee vendor qualification processes • Identify and implement continuous improvement initiatives within the quality system • Monitor key quality metrics and report trends to senior leadership • Ensure proper investigation and resolution of quality issues and complaints

🎯 Requirements

• Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, or related field (advanced degree preferred) • 8–12+ years of experience in pharmaceutical/biotech QA roles, with leadership responsibility • Strong knowledge of cGMP regulations and global regulatory requirements • Proven hands-on experience managing quality systems (batch review, CAPA, deviations, change control) • Strong analytical and problem-solving abilities • Ability to travel up to 10–20% as needed

🏖️ Benefits

• Health insurance • Retirement plans • Paid time off • Professional development opportunities