Associate Director, Assembly & Packaging

Job Description Summary

The Associate Director, Assembly & Packaging leads the teams responsible for assembly and packaging for several different products. This role provides day-to-day leadership, operational oversight, and guidance to ensure assembly and packaging occurs safely, compliantly, and in alignment with company targets. The Associate Director partners cross-functionally to drive cGMP compliance, operational excellence, staff development, and continuous improvement across assembly and packaging operations. This role will have approximately 2-3 direct reports and 14-21 indirect reports.

 

Job Description

Location: This role is located in Durham, NC

Relocation assistance is not available for this position

Key Responsibilities:

• Lead and manage team responsible for product assembly and packaging.

• Provide guidance and oversight to meet safety standards, cGMP requirements, and site strategic objectives.

• Review and approve deviations, nonconformances, and CAPAs; partner closely with Quality to ensure effective, compliant resolution.

• Oversee timely completion and closure of batch-related documentation (batch records, SOPs) to support batch release and product disposition.

• Maintain a robust, role-based training program to deliver timely, efficient, and effective training for personnel; ensure training compliance and readiness.

• Participate in agency and internal audits, facility tours, and information requests; respond to observations per procedure and drive sustainable remediation.

• Develop, track, and present monthly metrics (e.g., schedule adherence, right-first-time, yield, deviations, training compliance) to monitor performance and drive accountability.

• Identify and implement continuous improvement opportunities (e.g., yield, cost, safety, compliance); leverage lean/operational excellence tools.

• Initiate and manage personnel actions, including recruiting, onboarding, performance management, training, promotions, and transfers; build a high-performing team.

• Collaborate cross-functionally with Quality, Engineering, Supply Chain, MSAT, HSE, and Planning to ensure seamless operations, tech transfers, and readiness for scale.

• Support budgeting, resource planning, and capacity modeling to meet production goals.

• Perform other related 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

Requirements

• B.S. degree in engineering or a related technical field; or equivalent industry experience.

• 7+ years of experience in GMP manufacturing operations, including secondary packaging

• Pharmaceutical industry experience preferred

• 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.

Core Competencies:

• Leadership and people development

• cGMP and FDA regulatory compliance

• Operational excellence and continuous improvement

• Decision-making and problem-solving (investigations/CAPAs)Cross-functional collaboration

• Planning, scheduling, and resource management

• Communication and technical writing

• Work Environment & Physical Requirements:

• On-site role in GMP manufacturing environment with required gowning and adherence to safety procedures.

• Ability to work in cleanroom/controlled environments and stand/walk for extended periods as needed.

• May require off-hours support to meet production schedules.

Novartis Compensation and Benefit Summary

The pay range for this position at commencement of employment is expected to be between $132,300 and $245,700/year; however, while