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Procedural Document Facilitator/Quality Management System Specialist IV
Ref No.: 18-12205
Location: Lexington, Massachusetts
Start Date / End Date: 09/14/2018 to 09/13/2019
New Title: Director R&D Process Documentation Lifecycle Management

• Directly supervise activities of staff and contractors assisting with Doc Control or Technical Writing tasks.
• Oversee activities of internal and/or external resources maintain the Process Modelling Tool

Process Documentation
• Establish and maintain cross functional forum to ensure currency and alignment of R&D process models and supporting documents.
• Define standards for content of Procedural Documents and Process Models and develop and deploy training that ensures those standards are consistently implemented across R&D.
• Effectively manage the workload of the Lifecycle Management & Support Leads (LMSL) to ensure efficient and timely process documentation completion and approvals
• Oversee the controls for processing GxP controlled documents and templates, including consistently applying formatting and standards across all document types while utilizing best practices for technical writing
• Identify, develop, and drive continuous improvement opportunities in Process models and Procedural documents

Training Implementation and Deployment Support
• Supports the Regulatory Compliance Training group in process based training assignments.

Inspection Readiness/PSMF Support
• Contributes to inspection readiness by participating in inspections, inspection readiness activities and regulatory agency support activities as assigned.
• Maintains the Core Quality Operations Components of the Pharmacovigilance System Master File (PSMF) and coordinates with the assigned QMS Lead(s) to ensure Quality operations inputs to the PSMF Annexes meet requirements.

• Bachelor's degree in a science, business or technical related field is required
• Minimum 10 years in R&D, Clinical Operations or Quality Assurance in a Pharmaceutical environment supporting GxP system is required.
• Knowledge of GxP regulations, guidelines and requirements applicable to pharmaceutical R&D.
• Knowledge of implementation and management of Quality Management Systems (QMS) and associated technology.
• Inspection support experience is desirable