Account Manager - Third Party Manufacturing (Hybrid)

The Account Manager, Third Party Manufacture (TPM) 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 Device Products.  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 the interest and affairs of 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 and individuals, the TPM Manager is responsible for leading various teams, providing program management and is recognized as the primary AbbVie representative to coordinate operational activities for existing and new products manufactured with the supplier.  Internal teams are made up of representatives from S&T, Quality, Planning & Logistics, Brand, and Finance.  The position will require significant interaction with participants from Allergan Aesthetics, R&D, Regulatory Affairs and CMC as well as other areas of the business such as Purchasing, Legal, etc.

The Account Manager, TPM will oversee third party manufacturing operations of device/component manufacturing ensure high quality product is delivered according to the forecasted demand.  Main supplier relationship contact person in charge of providing the organization, supervision, strategic initiatives, and technical support necessary to manage supply of Device products from key suppliers. 

Responsibilities include:

• 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.
• Ensure global logistics are in place to ship samples to the testing sites, and product to the fill finishing sites.
• Communicate to the TPM the product forecasts and agree on manufacturing and delivery schedules.
• In coordination with Supply Chain and IME 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.
• Ensure guidance provided by legal and tax counsel is followed.
• Resolve with suppliers any issue that might arise.
• Approve supplier invoices and ensure payments are processed in the time frame specified in the agreement.
• 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.
• Collaborate with CMC and Regulatory Affairs Departments to establish regulatory strategies, prepare for Type C meetings, support filing submissions, inspections, and responses to regulatory agencies requests.
• 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.

Travel is required up to 50% of time.

TPM Manager must consistently support collaborative efforts and promote a cooperative team environment at all levels.

Develop innovative approaches to program management and have very keen foresight to anticipate activities and events that may cause delays and develop and implement plans to prevent such delays.

Qualifications:

• Bachelors Degree, preferably in science or technical related field.  MSc or MBA degree is beneficial and preferred
• A minimum of 7 years of experience, more than 10 preferred, in areas such as: manufacturing, engineering, project management, quality and Science & Technology.
• Knowledge of device manufacturing
• Knowledge of quality regulations and standards affecting chemical, biological or medical devices (i.e. Quality Systems, FDA and EU regulations), knowledge of corporate, local, state, and federal regulations.
• The individual needs a broad business perspective, knowledge and understanding of manufacturing processes.
• Strong project experience and an ability to influence others are essential.
• 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/device development, manufacturing and supply activities.
• Issue identification and strong problem analysis and solution development skills.
• Exceptional workload management and organizational skills.
• Demonstrated team player and ability to work in a globally oriented work environment.
• Proficiency with common program management communication software tools (e.g. MS Project, PowerPoint, MS Word, Excel) and techniques (i.e. plans, schedules, presentations, etc.).
• Strong knowledge of business financial systems and tools.
• The incumbent will work with and influence a wide variety and number of highly skilled and experienced technical managers in the following areas: Brand, R&D, Quality, Regulatory, and Manufacturing.
• The incumbent will be highly visible to the upper management and will be expected to interface with other AbbVie Departments and Divisions, international affiliates, vendors, third party manufacturers and customers.