Project Manager, Quality Management Systems, Documentation – Contract

🔥 30 minutes ago

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Cristcot

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2008

🏥 Healthcare

🏭 Manufacturing

💊 Pharmaceuticals

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

Healthcare • Manufacturing • Pharmaceuticals

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 the strategic build-out, modernization, and lifecycle management of Cristcot's Quality Management System documentation • Coordinate department leaders, subject matter experts, consultants, contractors, vendors, service providers, and external business partners on documentation activities • Develop and maintain the enterprise SOP Development Master Plan • Lead cross-functional meetings to design, develop, and implement regulated processes • Manage controlled procedures from initiation through implementation • Coordinate document creation, review, approval, revision, consolidation, periodic review, and obsoletion • Build and maintain project schedules, dashboards, status reports, executive metrics, and procedure trackers • Track documentation milestones, dependencies, deliverables, risks, actions, observations, and remediation commitments • Review documents for consistency, clarity, formatting, terminology, templates, and document-control requirements • Gather and review procedures, work instructions, templates, process maps, and supporting records from external partners • Maintain records of external communications, decisions, commitments, and document exchanges • Coordinate with Quality, Regulatory Affairs, Clinical Operations, CMC/Supply Chain, IT, Medical Affairs, Commercial, Finance, and HR • Identify opportunities to simplify procedures, eliminate duplicate documentation, improve workflow efficiency, standardize language, reduce complexity, and support inspection readiness • Provide routine reports to the Sr. Director of Quality • Ensure documentation activities comply with applicable 21 CFR requirements, ICH Guidelines, GCP/GMP requirements, ALCOA++ principles, and company document-control procedures

🎯 Requirements

• Bachelor's degree in Life Sciences, Engineering, Pharmaceutical Sciences, Quality, Business, or Project Management • 8+ years of pharmaceutical, biotechnology, or medical device experience • 3+ years managing cross-functional projects • Experience supporting GxP Quality Systems • Experience with controlled documentation • Experience implementing or managing electronic Quality Management Systems (eQMS) • Master's degree and/or Project Management Professional (PMP) certification preferred • Experience working in startup or rapidly growing organizations preferred • Knowledge of 21 CFR Parts 4, 11, 210/211, and 820 where applicable • Knowledge of ICH Guidelines, GCP/GMP requirements, ALCOA++ principles, and company document-control procedures