Summary: We are seeking a Business / Quality Process Manager to join our Process and Data Management (PDM) team within IM Quality Systems. In this role, you will act as a critical bridge between R&D business partners and procedural document deployment, ensuring highly technical and regulatory information is accurately translated into clear, compliant documentation. You will own the end-to-end process mapping, writing, and quality checking of procedural and training documents, ensuring adherence to GCP (Good Clinical Practice) standards within clinical R&D and device business frameworks. Roles & Responsibilities:
Process Mapping & Documentation: 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.
GCP Compliance: Ensure all process documents and procedural content strictly align with Good Clinical Practice (GCP) guidelines and broader Quality Management System (QMS) frameworks.
Training & Curriculum Deployment: Assist in setting up training curricula, drafting communication materials for training rollouts, and deploying training modules via the Learning Management System (LMS).
Project & Meeting Management: 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.
Cross-Functional Collaboration: 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).
Numbers & Facts
Location
West Chester, PA
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Skills
Biotech and Pharmaceuticalunmatched
Business Process Managementunmatched
Business Skillsunmatched
Clinical Practices/Protocolsunmatched
Communication Skillsunmatched
Cross-Functionalunmatched
Data Managementunmatched
Data Processingunmatched
Document Managementunmatched
Documentationunmatched
GCP (Good Clinical Practices)unmatched
Interviewing Skillsunmatched
Learning Management System (LMS)unmatched
Logisticsunmatched
Maintain Complianceunmatched
Presentation/Verbal Skillsunmatched
Problem Solving Skillsunmatched
Process Managementunmatched
Product Data Management (PDM)unmatched
Quality Managementunmatched
Regulationsunmatched
Regulatory Requirementsunmatched
Research & Development (R&D)unmatched
Schedule Developmentunmatched
Support Documentationunmatched
Technical Writingunmatched
Training/Teaching Curriculumunmatched
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