Senior Associate Manufacturing - New Product Introduction Systems (Multiple Positions)

Responsibilities

• Facilitate cross-functional Quality Risk Assessments (QRAs), including planning sessions, coordinating participants and source information, guiding structured risk discussions, documenting decisions, and supporting review and approval.
• Prepare and maintain QRA reports, Failure Modes and Effects Analyses (FMEAs), risk action logs, and supporting records in accordance with applicable procedures and quality requirements.
• Create and maintain process Bills of Materials (BOMs) based on approved process and manufacturing requirements.
• Coordinate BOM inputs, reviews, and reconciliation across Supply Chain, MES, SUS, Manufacturing, and other stakeholders to support accurate material readiness and alignment across systems and documents.
• Own assigned NPI Change Control records under management guidance; prepare and maintain record content, coordinate required impact assessments and implementation planning, and manage records through applicable lifecycle phases.
• Track pre-implementation, implementation, and post-implementation tasks, dependencies, due dates, and deliverables; follow up with task owners and escalate risks or delays.
• Verify that task completion documentation includes the required objective evidence, traceability, and supporting information before routing for approval or closure.
• Maintain trackers and provide clear, routine status readiness updates to NPI management and cross-functional partners.
• Build effective relationships across functions, communicate moderately complex issues clearly, navigate ambiguity, and apply structured problem-solving to support timely execution.

Basic Qualifications

• Master's degree OR Bachelor's degree and 4 years of Manufacturing or Operations experience OR Associate's degree and 8 years of Manufacturing or Operations experience OR High school diploma / GED and 10 years of Manufacturing or Operations experience

Preferred Qualifications

• Degree in Science, Engineering, Supply Chain, Operations, or a related field.
• Experience in GMP biotechnology or pharmaceutical manufacturing, manufacturing support, Process Development, Quality, or Supply Chain.
• Experience facilitating cross-functional Quality Risk Assessments, FMEAs, or similar structured risk-management activities.
• Experience using Quality Management Systems such as Veeva QMS or TrackWise for Change Controls, Continuous Improvement records, deviations, CAPAs, or risk-related records.
• Experience creating or maintaining process or manufacturing Bills of Materials and coordinating material readiness across multiple functions.
• Working knowledge of drug substance manufacturing and the relationship between process requirements, materials, manufacturing documents, and electronic batch records or MES.
• Strong cross-functional project coordination, meeting facilitation, technical writing, and compliant documentation skills.
• Ability to manage multiple priorities, maintain trackers, follow up on actions, and deliver work to established timelines.
• Excellent written and verbal communication skills with the ability to build effective relationships in a matrix environment.
• Ability to work independently within a defined scope, recognize when guidance is needed, and escalate risks promptly.