Associate Director, External Manufacturing - Aseptic
AbbVie
4 hours ago
Remote friendly (North Chicago, IL)
United States
$137,500 - $261,000 USD yearly
Operations
Associate Director, External Manufacturing
Responsibilities:
- Serve as primary contact for external manufacturing supplier relationships; provide organization, supervision, strategic initiatives, and technical support to manage supply of designated products.
- Ensure high-quality product is manufactured in compliance with local and international regulations and released/delivered per forecasts, schedules, and planned cost.
- Manage projects/programs affecting AbbVie to ensure cost-effective, marketable, and manufacturable products and maximize profitability across the product lifecycle.
- Negotiate Manufacturing Service Agreement and amendments; ensure compliance with agreement terms.
- Establish effective planning and material procurement strategies to supply required materials to TPM.
- Communicate product forecasts; agree on manufacturing and delivery schedules; coordinate with Supply Chain and Planning to meet demand forecasts.
- Participate in development of Financial Operating Plan, Updates, LRP, and standard processes; ensure financial goals are met.
- Coordinate Steering Committee; monitor Virtual Operation Teams to evaluate performance, address issues, and escalate when needed.
- Review status reports and provide updates to senior leadership.
- Collaborate with technical and quality teams to review process performance/quality trends and agree on process improvement plans.
- Establish governance, guidelines, and communication channels; ensure supplier quality systems/documentation meet regulatory requirements and address inspection responses/commitments.
- Coordinate with QA for annual quality management review and periodic audits; investigate deviations, ensure timely product disposition decisions, and establish/track performance metrics.
- Develop, implement, and manage programs/projects covering scope, cost, time/resource, communication, and risk management.
Qualifications:
- Bachelor’s degree (preferred in science/technical field); MSc or MBA preferred.
- 10+ years of experience in manufacturing, engineering, project management, quality, and S&T.
- Broad business perspective and strong understanding of manufacturing processes.
- Strong project experience; ability to influence others.
- Preferred: experience managing subcontracted relationships.
- Proven leadership with excellent communication skills (listening, verbal, presentation, written).
- Strong strategy development and planning skills; knowledge of pharmaceutical development, manufacturing, and supply.
- Strong issue identification, problem analysis, and solution development skills.
- Team player; ability to work in a globally oriented environment.
- Strong knowledge of business financial systems and tools.
Benefits (as stated):
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) for eligible employees.
- Eligible for short-term incentive programs and long-term incentive programs.
Responsibilities:
- Serve as primary contact for external manufacturing supplier relationships; provide organization, supervision, strategic initiatives, and technical support to manage supply of designated products.
- Ensure high-quality product is manufactured in compliance with local and international regulations and released/delivered per forecasts, schedules, and planned cost.
- Manage projects/programs affecting AbbVie to ensure cost-effective, marketable, and manufacturable products and maximize profitability across the product lifecycle.
- Negotiate Manufacturing Service Agreement and amendments; ensure compliance with agreement terms.
- Establish effective planning and material procurement strategies to supply required materials to TPM.
- Communicate product forecasts; agree on manufacturing and delivery schedules; coordinate with Supply Chain and Planning to meet demand forecasts.
- Participate in development of Financial Operating Plan, Updates, LRP, and standard processes; ensure financial goals are met.
- Coordinate Steering Committee; monitor Virtual Operation Teams to evaluate performance, address issues, and escalate when needed.
- Review status reports and provide updates to senior leadership.
- Collaborate with technical and quality teams to review process performance/quality trends and agree on process improvement plans.
- Establish governance, guidelines, and communication channels; ensure supplier quality systems/documentation meet regulatory requirements and address inspection responses/commitments.
- Coordinate with QA for annual quality management review and periodic audits; investigate deviations, ensure timely product disposition decisions, and establish/track performance metrics.
- Develop, implement, and manage programs/projects covering scope, cost, time/resource, communication, and risk management.
Qualifications:
- Bachelor’s degree (preferred in science/technical field); MSc or MBA preferred.
- 10+ years of experience in manufacturing, engineering, project management, quality, and S&T.
- Broad business perspective and strong understanding of manufacturing processes.
- Strong project experience; ability to influence others.
- Preferred: experience managing subcontracted relationships.
- Proven leadership with excellent communication skills (listening, verbal, presentation, written).
- Strong strategy development and planning skills; knowledge of pharmaceutical development, manufacturing, and supply.
- Strong issue identification, problem analysis, and solution development skills.
- Team player; ability to work in a globally oriented environment.
- Strong knowledge of business financial systems and tools.
Benefits (as stated):
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) for eligible employees.
- Eligible for short-term incentive programs and long-term incentive programs.