job summary: Procedural Document Facilitator/Quality Management System Specialist IV True Title: Director R&D Process Documentation Lifecycle Management Job Responsibilities
- 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
- 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
Education & Qualifications
- 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
- Medical, Dental, and Vision Insurance
- 401K Plan with Company Match
- Life and AD&D Insurance
location: Lexington, Massachusetts
job type: Contract
salary: $88.19 - 103.76 per hour
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.