Process And Procedures Quality Manager

Job Summary:

The Global Development, Process & Procedures (P&P) Quality Manager TEMP is responsible for maintaining and carrying out the use of quality content standards, style guides and templates to ensure the quality and consistency of procedural documents (Standard Operating Procedures (SOP), Work Instructions (WI), Business Practice Toosl (BPTs), Forms and Templates.

A typical day will include the following:

• Prepares project-specific initial impact assessment
• Minimum a BS/BA Degree with 5+ years of meaningful experience, or a MS Degree and 4+ years of meaningful experience.
• Monitors projects to identify impacts to documents on the crucial procedures list; notifies Vendor Relationship Management (VRM) Rep. of changes and provides copies of approved documents to VRM Rep upon approval
• Negotiates sophisticated situations without direct authority
• Detailed-oriented with ability to apply details to project/department goals/strategy
• Performs quality review of procedural documentation to:
• Ability to apply critical thinking and situational analysis to tackle problems and prioritize with varying levels of urgency
• Proven understanding of GCP, GVP and regulatory requirements
• Ensure deliverables enforce to standards
• Collect and evaluate metrics to identify trends and provide recommendations for continuous improvements to further strengthen procedural document development
• Written and verbal communication skills
• This role might be for you if:
• Maintains the quality calendar, identifying and adjudicating potential conflicts for the quality review schedule to minimize impact to projects timelines
• Experience in a Global regulated environment is required.
• Handle workflows for Periodic Reviews and Administrative changes
• Self-motivated with the ability to work optimally in a multifaceted environment
• Identify and evaluate issues and/or gaps in procedural document content; in collaboration with P&P Ops Mgr and Author, propose effective solutions
• Requirements:
• Performs workflow quality checks to ensure accuracy of content upload and EDMS metadata
• Support inspection management activities by providing copies of procedural documents, as requested
• Showed strength in project management, teamwork and negotiation of sophisticated situations