Job Description
Purpose:
Manage a team of Manufacturing Professionals responsible for Third Party Manufacture (TPM) contracts for Medical Devices or Combination Products. Assure that high quality products are manufactured in compliance with local and international regulations, and released and delivered according to the established forecasts, schedules, and cost planned. Ongoing monitoring quality and delivery performance while minimizing risks associated with outsourcing production to a Third-Party Manufacturer.
Responsibilities
* Lead a team of AbbVie TPM Account Managers to negotiate and manage Manufacturing Service Agreements (MSA), contract amendments, and updates as needed, while ensuring compliance with the terms of the agreements. Ensure global logistics are in place to support all phases of the manufacturing agreement in accordance with Purchasing and Supplier Quality expectations.
* Lead the development of ECM Device Financial Operating Plan, updates, LRP, and standard processes, and assure the financial goals are met. Monitor and control manufacturing costs to ensure efficient use of resources while maintaining product quality.
* Ensure timely communication with TPM in all aspects of the product agreement including product forecasts, manufacturing and delivery schedules. Identify, evaluate, and maintain strong relationships with third-party manufacturers to ensure quality production and timely delivery.
* Monitor manufacturing performance; apply OPEX (Operational Excellence) metrics as appropriate and ensure TPM manufacturing processes and standards align to deliver product in accordance with AbbVie quality & performance expectations.
* Assure in coordination with internal AbbVie functional partners that the TPM has the required quality systems and documentation to meet regulatory requirements, follow up inspection responses and commitments. Coordinate with PQA, the annual quality management review and periodic audits of the TPM. Assure deviations are properly investigated and product disposition decisions are made in a timely manner.
* Coordinate routine management reviews and provide ongoing communication informing internal and TPM stakeholders of performance against expectations, highlighting issues, actions, and ongoing improvements to increase performance at TPMs.
* Identify and select Third-Party Manufacturers (TPM); ensure team engagement on cross-functional evaluation of new product needs and TPM's due diligence initiatives.
* Identify potential disruptions like geopolitical instability, natural disasters, or labor issues and develop mitigation strategies.
* Ensure the manufacturer adheres to all relevant regulations regarding safety, environmental standards, and labor practices.
* Foster a collaborative partnership with TPMs to ensure mutual understanding and commitment to quality & performance.
* Lead a performance improvement culture & programs across TPMs; guide Account Managers to anticipate and act on ideas to increase efficiency and effectiveness.
* Establish and manage clear team expectations regarding roles & responsibilities, G&O's while championing and modeling AbbVie's performance and talent management practices.
* Develop and manage staff through hiring, managing performance, developing talent and providing clear expectations.
Qualifications
Requirements
* Bachelor's Degree required in a technical field; advanced technical degree (Master's or Doctorate Degree) strongly preferred.
* 15+ years' experience including manufacturing of Medical or Electro-Mechanical Devices.
* Strong technical and manufacturing assembly management experience.
* Progressively increased responsibility and performance as supervisor, department manager and leader in Operations (Manufacturing, Quality, Engineering, etc.). Proven ability to inclusively manage and develop teams.
* Strong communication skills, ability to build trust and rapport, clear goal setting, fostering collaboration, promoting creativity, and adapting leadership style to suit the team's needs.
* Business acumen coupled with functional leadership experience is required to ensure effectiveness and high performance in a complex operation.