Project Manager, Quality Management Systems & Documentation

Role Description

The Project Manager, Quality Management Systems & Documentation is responsible for leading the strategic build-out, modernization, and lifecycle management of Cristcot's Quality Management System (QMS) documentation. This position will partner with Quality and functional leaders across the organization to ensure company procedures are developed, revised, consolidated, and retired in a structured, compliant, and efficient manner as Cristcot transitions from a clinical-stage organization to commercial operations.

The successful candidate is highly organized, detail-oriented, comfortable working across departments, and experienced in regulated pharmaceutical, medical device, or biotechnology environments. This is a 6-12 month 1099 Contract.

Primary Relationships

• Within Cristcot: The Project Manager, QMS & Documentation will coordinate with department leaders and subject matter experts to identify required procedures and documentation gaps.
• Outside Cristcot: The Project Manager, QMS Documentation will coordinate document-development activities with consultants, contractors, vendors, service providers, and external business partners as well as support vendor oversight activities by tracking documentation-related actions, observations, and remediation commitments.

Primary Job Responsibilities

• Function as the central project manager for all controlled documentation initiatives.
• Drive timelines, coordinate cross-functional stakeholders, remove project obstacles, and ensure procedures align with applicable GxP regulations, industry best practices, and company objectives.
• Develop and maintain the enterprise SOP Development Master Plan.
• Lead cross-functional meetings with key stakeholders to design, develop, and implement regulated processes that ensure compliance with applicable regulatory requirements and business objectives.
• Manage the end-to-end lifecycle of controlled procedures from initiation through implementation.
• Coordinate document creation, review, approval, revision, consolidation, and obsoletion activities.
• Build and maintain project schedules, dashboards, status reports, and executive metrics.
• Develop and maintain metrics including SOP creation progress, revision cycle times, document approval timelines, training completion status, overdue reviews, document inventory, and project milestone completion.
• Develop and maintain a company-wide procedure development and remediation plan.
• Manage the creation, revision, consolidation, periodic review, and obsoletion of controlled procedures.
• Maintain a centralized tracker of procedures, owners, status, due dates, dependencies, and approvals.
• Review documents for consistency, clarity, formatting, terminology, and alignment with Cristcot templates and document-control requirements.
• Obtain and review applicable procedures, work instructions, templates, process maps, and supporting records from external partners.
• Maintain records of external communications, decisions, commitments, and document exchanges.
• Support vendor oversight activities by tracking documentation-related actions, observations, and remediation commitments.
• Track milestones, dependencies, deliverables, and risks associated with documentation projects.
• Cross-functional coordination with Quality, Regulatory Affairs, Clinical Operations, CMC/Supply Chain, IT, Medical Affairs, Commercial, Finance, and HR to gather process information, facilitate document reviews, resolve conflicting requirements, maintain project timelines, and obtain approvals.
• Identify opportunities to simplify company procedures, eliminate duplicate documentation, improve workflow efficiency, standardize process language, reduce document complexity, and support inspection readiness.
• Provide routine reports to Sr. Director of Quality.
• Ensure all documentation activities comply with 21 CFR (Parts 4, 11, 210/211, 820 where applicable), ICH Guidelines, GCP/GMP requirements, ALCOA++ principles, and Company Document Control procedures.

Qualifications

• Bachelor's degree in Life Sciences, Engineering, Pharmaceutical Sciences, Quality, Business, or Project Management.
• Master's degree and/or Project Management Professional (PMP) certification preferred.
• 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).
• Experience working in startup or rapidly growing organizations preferred.