Associate Director, Assembly & Packaging

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 salary ranges are effective from 1/1/25 through 12/31/25, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.