Supplier Quality Senior Specialist

Lantheus • Bedford, MA

6d • $111,000 - $185,000 • Hybrid

About The Position

The Supplier Quality Senior Specialist 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. This Senior Specialist is responsible for acting as the primary point of contact and relationship manager for Third Party Logistics (3PL) and Pharma Partners. They are also responsible for developing and managing an Approved Vendor List and ensuring procedures are in place for supplier lifecycle management, including initial assessment, qualification and onboarding, monitoring and offboarding, with continuous improvement initiatives. Domestic and international suppliers consist of Contract Manufacturing Organizations (CMO), drug substance precursors, active pharmaceutical ingredient (API) providers, raw material and component suppliers, contractors, 3PL and service providers.

The Supplier Quality Senior Specialist oversees supplier performance on an ongoing basis, implements a program of monitoring and continuous improvement and, if necessary, eliminate suppliers from the approved vendor list. This Senior Specialist executes all actions that contribute to the success of maintaining a compliant vendor management program. They also maintain oversight and execution of all assigned Corrective and Preventative actions related to Supplier Quality management.

The position can be either remote or hybrid, with occasional onsite requirements at the department location in Bedford, Massachusetts.

Requirements

• Requires a BS degree in a scientific discipline and minimum of 7+ years’ experience in a GMP environment, preferably in a Quality- related discipline or Supplier Quality Management within the Pharmaceutical, Biotech and /or Medical Device industry, or equivalent combination of education and experience.
• 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.
• Must have demonstrated experience with Quality Management System databases.
• Requires the 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.

Nice To Haves

• Travel to suppliers (about 25%) will be required based on business needs.
• Strong understanding of principles of Analytical/Chemistry required to support Supplier Analytical Testing and method development preferred but not required.

Responsibilities

• Adhere to 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.
• Serve as primary point of contact for 3PL and Pharma Partners.
• Own and manage 3PL/Pharma Partner relationships; attend and/or own periodic touchpoints.
• Support external audit planning, including risk-based execution and observation remediation.
• 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.
• Own and resolve supplier-related deviations and 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.
• Serve as Quality lead for new vendor triage process and provide Supplier Quality review of new material setup in GxP systems
• Support disposition of discrepant, damaged, or expired supplier materials.
• 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.
• 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 Subject Matter Expert for internal Committees and Boards as required in support of supplier management as determined by business need.

Benefits

• comprehensive health benefits package that includes medical, prescription drug, dental, and vision coverage.
• life and disability benefits
• pre-tax accounts
• a 401(k) with company contribution
• a variety of other benefits
• generous time off package including paid vacation, holidays, sick days, and paid parental leave.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior