Project Manager - Quality

Overview

• Project focused on validating manufacturing lines in Jacksonville (JAX) for 6 new lines starting with the pilot line for the first 6 months
• Significant activity around:
• Site readiness
• Registration
• Lab readiness (IQ/OQ/PQ & method transfer)
• Core emphasis on quality oversight, validation, and execution
• Timeline driven, execution-focused program

Roles Under Consideration

1. Project Manager (PM) - Quality Focus

Key Responsibilities:

• Lead day-to-day project execution
• Manage timelines, milestones, and follow-ups
• Drive actions and ensure delivery
• Provide quality oversight across workstreams
• Coordinate site readiness and validation activities

Requirements:

• Strong project management experience (quality-related preferred)
• Experience in:
• Manufacturing / site startup
• Medical devices (Class III preferred)
• Regulatory environment
• Must be hands-on (limited time for training)
• Ability to manage execution vs. strategy

Additional Workstreams

• Micro & Incoming: Method transfers, procedure review/approval
• Documentation: Creation and updates required across functions
• Equipment Acquisition & Qualification
• Procedure Modifications

Program Timeline & Milestones

• Overall: long-term effort supporting 6 lines

Key Focus Areas

• Site readiness execution
• Validation (equipment, process, labs)
• Method transfer
• Quality oversight and regulatory compliance
• Fast-paced execution with limited training ramp-up

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

To find out more about Real, please visit www.realstaffing.com