Quality Process Manager

Roles & Responsibilities

• Collaborate directly with R&D business partners to extract operational information, translate it into clear procedural documents, and perform rigorous process mapping and quality checks.
• Ensure all process documents and procedural content strictly align with Good Clinical Practice (GCP) guidelines and broader Quality Management System (QMS) frameworks.
• Aid in setting up training curricula, drafting communication materials for training rollouts, and deploying training modules via the Learning Management System (LMS).
• Define project schedules, support procedural document approvals via the Electronic Document Management System (EDMS), and set up/facilitate alignment meetings with internal and external stakeholders.
• Maintain continuous communication with business owners, resolve procedural issues, and ensure compliant documents are fully installed for dedicated processes.

Qualifications & Requirements

• Education: Bachelor's degree required.
• Experience: 5+ years of relevant professional experience in a medium to large corporate organization (Pharma, Biotech, or Clinical R&D preferred).
• Domain Expertise: Deep understanding of GCP (Good Clinical Practice) content and regulatory requirements applicable to procedural documents.
• Core Skills: Exceptional technical writing, process mapping, and verbal communication skills. Ability to interview business partners, extract complex details, and synthesize them into clear processes.
• System Knowledge: Familiarity with automated systems, specifically Electronic Document Management Systems (EDMS) and Learning Management Systems (LMS).
• Logistics: Must be comfortable working in the EST time zone (if remote) or commuting hybrid (3 days onsite in West Chester, PA).