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).
