Associate Director, External Manufacturing - Aseptic

AbbVie, Inc•Worcester, MA

40d

About The Position

The Associate Director, External Manufacturing will be the main supplier relationship contact person in charge of providing the organization, supervision, strategic initiatives, and technical support necessary to manage supply of designated products. The role will ensure that high quality product is manufactured in compliance with local and international regulations, and released and delivered according to the established forecasts, schedules, and cost planned. This position also manages projects and programs impacting AbbVie to ensure a cost effective, marketable and manufacturable product and maximizes profitability throughout its life cycle. Through matrix management of cross functional groups/individuals, the Associate Director, TPM is responsible for leading various teams without direct authority, providing program management support, and is the primary AbbVie representative to coordinate operations for existing and new products manufactured with the supplier.

Requirements

Bachelor's Degree, preferably in science or technical related field. MSc or MBA degree is preferred.
A minimum of 10+ years of experience, in areas such as: manufacturing, engineering, project management, quality and S&T. External Manufacturing experience and aseptic experience in external manufacturing required
The individual needs a broad business perspective, knowledge and understanding of manufacturing processes.
Strong project experience and an ability to influence others are essential.
Previous experience managing subcontracted relationships preferred.
Proven leadership ability with superior communication skills including listening, verbal, presentation and written.
Strong strategy development and planning skills coupled with necessary knowledge of pharmaceutical development, manufacturing and supply activities.
Issue identification and strong problem analysis and solution development skills.
Demonstrated team player and ability to work in a globally oriented work environment.
Strong knowledge of business financial systems and tools

Responsibilities

Participate in the negotiation of the Manufacturing Service Agreement and amendments, and ensure compliance with the terms of the agreements.
Ensure effective planning and material procurement strategies are in place to supply the TPM with the required materials.
Communicate to the TPM the product forecasts, and agree on manufacturing and delivery schedules. In coordination with Supply Chain and Planning, ensure the supplier delivers the product according to the demand forecasted.
Actively participate in the development of Financial Operating Plan, Updates, LRP, and Standard processes, and ensure the financial goals are met
Coordinate the Steering Committee and monitor that the Virtual Operation Teams meet periodically to evaluate performance, address issues, and if necessary escalate.
Review status reports and prepare updates for Senior leadership.
In collaboration with technical and quality teams, periodically review process performance, quality trends, and agree on process improvement plans.
Establish governance, guidelines, and communication channels. Ensure in coordination with the quality units that the supplier has the required quality systems and documentation to meet regulatory requirements, follow up inspection responses and commitments.
Coordinate with QA, the annual quality management review and periodic audits of the TPM. Ensure deviations are properly investigated and product disposition decisions are made in a timely manner. Establish performance metrics and periodically track performance.
Develop, implement and manage the programs or projects such as scope, cost, time & resource management, communication and risk management through the initiating, planning and executing phases of the project.