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Manager, Supplier Quality

Company: Lantheus Holdings, Inc.
Location: Billerica
Posted on: August 2, 2022

Job Description:

The individual in this position is responsible for ensuring that Quality systems, policies, and procedures (SOP's) between LMI Quality, Supply Chain, MT&D and R&D are compliant and aligned with business needs. Responsible for developing and managing the organizations GxP Approved Supplier List and ensuring robust procedures are in place to qualify GxP suppliers, third-party contractors, and service providers. Oversee and report on global supplier performance on a routine basis. Execute all actions that contribute to the success of maintaining a Compliant vendor management program. Maintain oversight and execution of all assigned Corrective and Preventative actions related to Supplier Quality management.Essential Functions Adhere to existing approved supplier program to ensure appropriate controls, processes and procedures are maintained to ensure full compliance with current cGMP and global regulatory requirements and alignment with industry best practices.

Evaluate supplier performance and quality data sources to identify quality issues and trends, as well as implement corrective and preventive actions to hold suppliers accountable to documented performance improvement plans. Oversee contract manufacturer (CMO) production processes through internal batch release to ensure timely closure of external Quality investigations events and product disposition. .

Own and resolve supplier related CAPAs relating to non-conforming materials and services to identify true root causes and drive timely closure with vendors. Demonstrated success facilitating Root Cause Analysis activities and managing actions to closure.

Assure planned changes to supplier management processes are fully approved and compliant with LMI procedures and regulatory guidelines. Develop and maintain a strong partnership with critical suppliers and act as the Subject Matter Expert (SME) to all internal partners for quality related issues from suppliers, contractors, and consultants. Partner with Procurement and R&D, at an early stage, to identify development as well as commercial suppliers and contractors for new product introduction planning. .

Act as the Lead Quality representative to support all continuous improvement activities for vendor management projects to support cost control programs, inventory management planning, compliance and business risk mitigation programs.

Function as an internal Quality consultant and resource for site training/education coordination needs, including providing leadership and Quality guidance to operations. Actively demonstrates Lantheus values: Help people be their best Respect one another and act as one Own the solution and make it happen Learn, adapt and win Know someone's health is in our hands

Serves as Subject Matter Expert internal Committees and Boards as needed in support of vendor management as determined by business need.Typical Minimum Skills and Experience and Education Requires a minimum of a BS degree in a scientific discipline and 5+ years in a GMP environment, preferably in a Quality related discipline or equivalent combination of education and experience. Incumbent must have excellent written, verbal and presentation skills. Must be able to communicate effectively with all levels of management, both internal and external. Minimum of 7+ year experience within the Pharmaceutical, Biotech and /or Medical Device industry. Must have a good understanding of cGMP requirements by FDA, EMA, ICH Q8, 9 and 10 etc. Must have demonstrated experience with Quality Management System databases. Requires ability to work independently to own projects and execute to 100% completion with minimal supervision. Strong negotiating and collaboration skills are essential; incumbent must be able to influence and drive suppliers to high levels of performance.Other Requirements Travel (domestic and international) to suppliers will be required based on current business needs. Strong understanding of principles of Analytical/Chemistry required to support Supplier Analytical Testing and method development preferred but not required.

Keywords: Lantheus Holdings, Inc., Billerica , Manager, Supplier Quality, Executive , Billerica, Massachusetts

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