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Manager, Supplier Quality Assurance
2 months ago
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 of RoleSupports quality and technical activities to assure Contract Manufacturing Organization (CMO) and PET Manufacturing Facilities exceed Lantheus' requirements for Pharmaceutical Products and Positron Emission Tomography (PET) Drug manufacturing.Key Responsibilities/Essential FunctionsIndependently review and evaluate technical deviations, investigations, CAPAs, change controls, and OOS. Provide feedback to CMOs and documents associated records within the Lantheus internal Quality Management System (QMS).Support process improvements of PET to assure compliance with regulatory, procedures, standards and contractual compliance.Support and perform PET site qualification audits and documentation to support regulatory filings.Review and approve supplier corrective action plans and oversee plan execution.Maintain current audit schedule and status in relevant system/trackerCollect and review documentation for the CMOs used in performing activities relevant to PET manufacturing and testing such as Master Batch Records, EM reports and others as applicableProvide feedback for the review of Master Batch Records and critical SOPs from the CMOs.Review EM reports, Media Fills and BR based on procedures in place.Provide technical support for FAR and recall evaluation/contents.Participate in weekly/monthly/quarterly meetings for PET supply with CMOsSupport inspection readiness and provide audit support, as required.Build a strong working relationship with MT&D, R&D, Supply, and Regulatory to support a high performance culture.Collaborate well with project team and work efficiently in a team environment. Communicate effectively with management, contractors, consultants and vendors.Support and lead continuous improvement activities for the managed activities, as needed.Actively demonstrate the Lantheus values of accountability, quality, efficiency, customer service, collaboration and safetyBasic QualificationsBachelor's degree required in a related science discipline.Minimum of 5+ years quality assurance / technical experience in a pharmaceutical/life-science environment, or 3+ years with a Master's degreeMust demonstrate thorough knowledge of conducting effective investigations.Working knowledge with PET Good Manufacturing Practice guidance and FDA regulations regarding the manufacturing of PET drugs is preferred.Aseptic processing experience preferred.Excellent Documentation skills.Excellent technical writing skills.Knowledge and understanding of GCPs and GMPs.Ability to work effectively with cross-disciplinary teams and with Suppliers.Flexibility and Adaptability.Experience in Sterile Manufacturing and CMO Management preferredStrong problem-solving skills, excellent communication skills both written and verbal.Proficiency with Microsoft Office to include Word, Excel, PowerPoint, Adobe Acrobat, and SharePoint.Demonstrated ability to work independently and in cross-functional teams.This position is site-based and requires a presence on-site of 3 days per week in Billerica, MA when not travelling.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.#LI-HYBRID
