Associate Director, Assembly & Packaging

Job Description Summary

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 $132300 and $245700/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.

EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment hiring training promotion or other employment practices for reasons of race color religion sex national origin age sexual orientation gender identity or expression marital or veteran status disability or any other legally protected status.

Accessibility and reasonable accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If because of a medical condition or disability you need a reasonable accommodation for any part of the application process or to perform the essential functions of a position please send an e-mail to or call 1 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Salary Range

Skills Desired