QMS Systems Lead

4 weeks ago

Billerica, United States Lantheus Full time

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 have helped physicians enhance patient care with our 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. Lantheus is in search of an innovative, transformative, high-energy, experienced Business Analyst for our Quality Systems team.

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 skills sets to be a part of a productive and inclusive team.

This individual will support the Quality business community executing requirements and coordinating with the technical community, IT project teams and business clients for Quality technical solutions including QMS, CDS, QC RDS, LIMS, NuGenesis ALM, etc. This role will work with the business to define functional business requirements and help develop, execute, deploy, and support the current Quality technical solutions and play a key role implementing new solutions supporting the Lantheus Digital Strategy.

Key Responsibilities/Essential Functions

Gather, develop, clarify and document functional/user business requirements Transform the users’ requirements into functional requirements Strong understanding of LIMS solutions (LabVantage preferred) Knowledge of integrating LIMS with Empower CDS Experience with the administration of at least one QMS Solution (AsurX, TrackWise, Veeva, MasterControl, etc.) Experience with the administration at least one CDS systems (Empower preferred) Experience with IT setup, troubleshooting, back-up, upgrades, & decommissioning lab equipment/software such as HPLC, GC, AA, UV/FTIR/Raman, titrators, endotoxins, total particulates, balances, pH meters, etc. Ability to collaborate with Project Managers on issues, concerns, schedules of deliveries and completion estimates Experience working in GxP validated environment and have contributed to the creation and execution of validation documents such as IQ and OQ

Skills And Experience And Education

BA/BS degree in Information Technology or Computer Science with 5+ years progressive experience in data integration Experience in the following areas preferred: Quality Controls within Manufacturing, Quality Systems & Document Management, Quality Assurance, Computer Systems Validation, GxP, Validated Change Control and Product Life Cycle Management Understanding of Computer Systems Validation and the full Software Life Cycle management Strong written and verbal communication skills Strong collaboration skills with the ability to work in a team dynamic across multiple functional organizations Experience in the life science industry or like industry essential Demonstrated analytical, troubleshooting, and problem-solving skills

Other Requirements

Non-routine overnight travel based on business need.

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