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Associate Director, External Manufacturing - Aseptic

AbbVie Inc.Worcester
On-site Full-time

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Experience Level

Mid to Senior

Qualifications

Qualifications:Bachelor’s Degree in a science or technical field; a Master’s degree or MBA is preferred. A minimum of 10 years of experience in manufacturing, engineering, project management, quality, and S&T, with specific experience in external manufacturing and aseptic processes required. A broad business perspective with in-depth knowledge of manufacturing processes. Strong project management experience with an ability to influence stakeholders effectively. Prior experience managing subcontracted relationships is preferred. Demonstrated leadership capabilities with excellent communication skills, including listening, verbal, presentation, and writing proficiency. Strong strategic development and planning skills, along with knowledge of pharmaceutical development, manufacturing, and supply chain activities. Proficient in issue identification, problem analysis, and solution development.

About the job

As the Associate Director of External Manufacturing, you will serve as the primary contact for supplier relationships, overseeing the strategic initiatives, organization, and technical support necessary for the effective management of our designated product supply. This role is pivotal in ensuring that high-quality products are manufactured in compliance with both local and international regulations, while also being delivered on schedule and within budget. You will manage various projects and programs that influence AbbVie, aiming to ensure that our products are cost-effective, marketable, and manufacturable, maximizing profitability throughout their life cycle. Through matrix management of cross-functional teams, you will lead diverse groups without direct authority, providing essential program management support and acting as the primary AbbVie representative for coordinating operations related to existing and new products manufactured by our suppliers.

Key Responsibilities:

  • Engage in the negotiation of Manufacturing Service Agreements and amendments, ensuring compliance with their terms.
  • Develop effective planning and material procurement strategies to supply the Third Party Manufacturer (TPM) with necessary materials.
  • Communicate product forecasts to the TPM and agree on manufacturing and delivery timelines. Collaborate with Supply Chain and Planning to ensure supplier delivery aligns with demand forecasts.
  • Contribute to the Financial Operating Plan, Updates, Long Range Planning (LRP), and Standard processes, ensuring financial objectives are met.
  • Coordinate the Steering Committee and ensure that Virtual Operation Teams convene regularly to assess performance and address any issues.
  • Prepare status reports and updates for senior leadership review.
  • In partnership with technical and quality teams, regularly assess process performance, quality trends, and devise improvement plans.
  • Establish governance frameworks, guidelines, and communication channels, ensuring that suppliers have the requisite quality systems in place to meet regulatory standards and follow up on inspection responses.
  • Coordinate with Quality Assurance to conduct annual quality management reviews and periodic audits of the TPM, ensuring timely investigation of deviations and product disposition decisions. Establish performance metrics and monitor them periodically.
  • Develop, implement, and manage programs and projects, focusing on scope, cost, time, resource management, communication, and risk management throughout the project lifecycle.

About AbbVie Inc.

AbbVie is dedicated to discovering and delivering innovative medicines and solutions that address serious health challenges today while preparing for future medical needs. Our mission is to make a significant impact in the lives of patients across key therapeutic areas such as immunology, oncology, neuroscience, and eye care, alongside our offerings in the Allergan Aesthetics portfolio. For more details about AbbVie, please visit www.abbvie.com.

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