Associate Director, Manufacturing Support

Role Summary

The Associate Director, Manufacturing Support leads cross-functional support for compounding, parts preparation, syringe & vial filling, visual inspection, and assembly & packaging. This role oversees the investigation portfolio, change control facilitation, finite scheduling, SOP authorship, and continuous improvement initiatives to ensure safe, compliant, and efficient operations. The position drives standardization across functions, enables timely lot disposition, and provides transparent performance reporting to the Site Leadership Team (SLT). This role will have approximately 12 direct reports.

Responsibilities

• Provide oversight and monitoring of the site investigation portfolio, ensuring compliance with relevant SOPs and escalation to SLT as required.
• Lead and manage teams that author, own, and facilitate investigations and corrective and preventive actions (CAPAs) spanning manufacturing, quality control, supply chain, engineering, and other site functions.
• Lead a team that facilitates change controls, capital projects, and process changes.
• Lead development and management of detailed, task-based finite schedules to align multi-functional activities and ensure seamless execution across compounding, parts prep, filling, inspection, and assembly & packaging.
• Author, review, and approve Standard Operating Procedures (SOPs) and related cGMP documentation; ensure clarity, compliance, and usability for shop-floor personnel.
• Establish and implement a visual factory manufacturing system to enable real-time, shop-floor-to-leadership communication of status, risks, and performance.
• Identify and lead continuous improvement projects focused on safety, quality, delivery, and cost; leverage lean and operational excellence methodologies to reduce variability and waste.
• Partner closely with Manufacturing, QA, QC, Engineering, Supply Chain, MSAT, and HSE to synchronize priorities and mitigate risks.
• Coach, mentor, and develop team members; drive a culture of accountability, collaboration, and proactive problem solving.
• Perform other related job duties as assigned.

Key Performance Indicators

• Meet project milestones (e.g, process qualifications, analytical qualification, regulatory submissions) per targeted timeframes and within budget
• Successful facility inspections and audits
• Quality and HSE indicators with target
• People development, retention, and performance management
• Performance management and employee relations, feedback, meetings, surveys
• Financial KPIs (CAPEX, Unit Cost, Inventory) within target

Core Areas Of Responsibility

• Investigations into non-conformances (NCRs)
• Corrective and preventive actions (CAPAs)
• Change control facilitation
• Finite scheduling
• SOP authorship
• Continuous improvement projects
• KPI tracking and reporting to SLT

Qualifications

• B.S. degree in engineering or a related technical field; or equivalent industry experience.
• 10+ years of experience in GMP manufacturing operations
• Pharmaceutical/Biopharma Industry experience required
• Knowledge of FDA regulations and GMP systems; strong understanding of cGMP documentation and compliance practices.
• Excellent oral and written communication skills; strong technical writing ability required.
• Proven ability to mentor and develop staff; foster a culture of continuous improvement and operational excellence.
• 5+ years experience leading and managing teams.
• Project management skill set, including strategic/tactical planning, team building, risk management, and budget adherence.
• Prior experience conducting deviation investigations in a cGMP environment.

Work Environment & Physical Requirements

• On-site role supporting GMP manufacturing areas (compounding, parts preparation, filling, inspection, packaging); adherence to gowning and safety procedures required.
• Ability to work in controlled/cleanroom environments and coordinate across shifts to meet operational needs.
• May require off-hours support to meet production schedules and investigation timelines.