Associate Director, Supplier Quality Management

Lantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio.

Lantheus is an entrepreneurial, agile, growing organization that provides innovative diagnostics, targeted therapeutics, and artificial intelligence (AI) solutions that empower clinicians to find, fight and follow disease. At Lantheus our purpose and values guide our behaviors in all interactions and play a vital role in creating a dynamic environment that contributes to our success. Every employee is crucial to our success; we respect one another and act as one knowing that someone's health is in our hands. We believe in helping people be their best and are seeking to bring together a diverse group of individuals with different viewpoints and skill sets to be a part of a productive and inclusive team.

Summary

The Associate Director of Supplier Quality Management is responsible for maintaining Lantheus's Supplier Quality Management (SQM) program, ensuring that systems, processes and procedures between Quality, Supply Chain, Technical Operations and R&D are compliant and aligned with business needs. Responsible for developing and managing an Approved Supplier List and ensuring procedures are in place to qualify suppliers, including Contract Manufacturing Organizations (CMO), raw material and component suppliers, contractors and service providers. Oversees supplier performance on an ongoing basis, implements a program of monitoring and continuous improvement with suppliers and, if necessary, eliminate suppliers from the approved supplier list.

The position is located in Billerica, Massachusetts.

Key Responsibilities/Essential Functions

• Lead the Supplier Quality Management function for Lantheus, setting a clear vision, strategy and process for the harmonized quality management of suppliers, contractors and consultants.
• Set team roles and responsibilities to ensure consistency and redundancy in routine job function along with project objectives.
• Ensure team responsibilities are communicated cross-functionally, appropriate representation is made available to meet compliance and business needs, and team development initiatives are established, aligning with company goals.
• Manage existing supplier lifecycle management program to ensure appropriate controls, processes and procedures are developed, implemented and maintained to ensure full compliance with regulatory requirements and alignment with industry best practices.
• Oversee vendor audit planning and execution utilizing a risk based process
• Oversee supplier performance and quality data sources and metric reporting to identify quality issues and trends, as well as implement corrective actions and effectiveness criteria to hold suppliers accountable to promised performance improvement plans.
• Oversee contract manufacturer (CMO) production processes through internal batch release to ensure timely closure of external quality events and product availability.
• Own and resolve supplier-related CAPAs relating to non-conforming materials and services to identify true root causes and drive timely closure with suppliers.
• Oversee supplier change management program, ensuring cross-functional participation and timely implementation to meet compliance standards and business needs.
• Assure planned changes to supplier management processes are fully approved and compliant with Lantheus procedures and regulatory guidelines.
• Develop and maintain a strong partnership with key suppliers and act as the primary conduit 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 programs and redundancy in supply.
• Act as the primary Quality representative for supplier management projects to support cost control programs, inventory management planning and compliance and business risk mitigation programs.
• Oversee and ensure adherence to supplier quality management budget plan

• Function as an internal consultant and resource for site training/education coordination needs, including providing leadership and information to operations.
• Serves as Supplier Quality representative on the Third party Supplier Steering Committee as well as other internal Committees and Boards as needed in support of supplier management as determined by business need.

Basic Qualifications

• Requires a BS degree in a scientific discipline and minimum of 8-10+ year experience in Supplier Quality Management within the Pharmaceutical, Biotech and /or Medical Device industry.
• Incumbent must have excellent written, verbal and presentation skills. Must be able to interact effectively with all levels of management, both internal and external.
• Must have a good understanding of cGMP requirements by FDA, EMA, ICH Q8, 9 and 10 etc.
• Strong negotiating and collaboration skills are essential; incumbent must be able to influence and drive suppliers to high levels of performance.

Other Requirements

• Travel to suppliers will be required based on business needs.
• Experience with SAP S/4HANA

Core Values

The ideal candidate will embody Lantheus core values:

• Let people be their best
• Respect one another and act as one
• Learn, adapt, and win
• Know someone's health is in our hands
• Own the solution and make it happen

Lantheus is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Lantheus is an E-Verify Employer in the United States. Lantheus will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Lantheus Talent Acquisition team at talentacquisition@lantheus.com.