Project Manager, Quality Management Systems, Documentation – Contract

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the strategic development, modernization, and lifecycle management of Cristcot's Quality Management System documentation.

• Collaborate with department leaders, subject matter experts, consultants, contractors, vendors, service providers, and external business partners on documentation initiatives.

• Create and sustain the enterprise SOP Development Master Plan.

• Facilitate cross-functional meetings to design, develop, and execute regulated processes.

• Manage controlled procedures from their initiation to implementation.

• Organize document creation, review, approval, revision, consolidation, periodic review, and obsolescence.

• Develop and maintain project schedules, dashboards, status reports, executive metrics, and procedure trackers.

• Monitor documentation milestones, dependencies, deliverables, risks, actions, observations, and remediation commitments.

• Evaluate documents for consistency, clarity, formatting, terminology, templates, and document-control standards.

• Collect and assess procedures, work instructions, templates, process maps, and supporting records from external collaborators.

• Keep records of external communications, decisions, commitments, and document exchanges.

• Collaborate with Quality, Regulatory Affairs, Clinical Operations, CMC/Supply Chain, IT, Medical Affairs, Commercial, Finance, and HR teams.

• Identify opportunities to streamline procedures, eliminate redundant documentation, enhance workflow efficiency, standardize language, reduce complexity, and maintain inspection readiness.

• Provide regular reports to the Sr. Director of Quality.

• Ensure that documentation activities adhere to relevant 21 CFR requirements, ICH Guidelines, GCP/GMP standards, ALCOA++ principles, and company document-control protocols.

⛳️ Requirements

• Bachelor's degree in Life Sciences, Engineering, Pharmaceutical Sciences, Quality, Business, or Project Management.

• 8+ years of experience in the pharmaceutical, biotechnology, or medical device sectors.

• 3+ years of experience managing cross-functional projects.

• Proven experience supporting GxP Quality Systems.

• Familiarity with controlled documentation.

• Background in implementing or managing electronic Quality Management Systems (eQMS).

• A Master's degree and/or Project Management Professional (PMP) certification is preferred.

• Experience in startup or rapidly expanding organizations is preferred.

• Knowledge of 21 CFR Parts 4, 11, 210/211, and 820 where relevant.

• Understanding of ICH Guidelines, GCP/GMP standards, ALCOA++ principles, and company document-control procedures.

🏝️ Benefits

• Competitive salary and comprehensive benefits package.

• Opportunities for professional development and career advancement.

• Collaborative and innovative work environment.

• Flexible working arrangements.