Position Summary
The Manufacturing Project Manager is responsible for planning, executing, and managing manufacturing projects within a regulated manufacturing environment. This role ensures strict compliance with applicable quality systems and regulatory requirements while delivering projects on time, within scope, and aligned with customer and operational expectations.
The Manufacturing Project Manager partners closely with Manufacturing, Quality, Engineering, Supply Chain, and Commercial stakeholders to support compliant, efficient, and high-quality production programs.
Key Responsibilities
Manufacturing Project Execution
- Plan, execute, and manage manufacturing projects from initiation through closeout in a regulated environment
- Ensure all project activities comply with internal quality systems, SOPs, and regulatory requirements
- Define project scope, timelines, deliverables, and success metrics
Regulatory Compliance & Quality Systems
- Maintain strong alignment with applicable cGMP and regulatory standards
- Ensure all documentation meets compliance and audit readiness requirements
- Support internal audits, customer audits, and regulatory inspections by providing complete project documentation and data
Cross-Functional Leadership
- Lead and coordinate cross-functional teams including Manufacturing, Quality Assurance, Quality Control, Engineering, Supply Chain, and Procurement
- Facilitate project meetings, stage-gate reviews, and stakeholder updates
- Serve as a primary point of contact for project communication and coordination
Process Improvement & Risk Management
- Analyze manufacturing and production data to identify risks, bottlenecks, and improvement opportunities
- Lead continuous improvement initiatives while maintaining regulatory compliance
- Identify project risks and implement mitigation plans to prevent delays or quality issues
Change Control & Qualification Support
- Manage change control activities related to process, equipment, or formulation changes
- Support equipment and process qualification activities as required
- Ensure proper assessment, documentation, approval, and implementation of changes
Customer & Stakeholder Communication
- Communicate project timelines, scope changes, and risks to internal teams and external stakeholders
- Support quotations, cost discussions, and customer-related manufacturing programs as needed
Qualifications
Education
- Bachelor's degree in manufacturing, Engineering, Life Sciences, Business, or a related field
Experience
- Proven experience managing projects in a regulated manufacturing environment
- Experience within nutraceutical, dietary supplement, pharmaceutical, food, or similar regulated industries strongly preferred
- Working knowledge of cGMP requirements and quality systems
Certifications & Skills
- PMP certification required
- Training or certification in Lean, Kaizen, Six Sigma, or Quality Systems preferred
- Experience with change control, CAPA, deviation management, and quality documentation
- Strong organizational, analytical, and communication skills
- Ability to manage multiple projects concurrently
Tools & Systems
- Experience using project management and ERP systems such as Monday.com and NetSuite is a plus
