I am a passionate advocate for science and a dedicated guide, advisor, and friend. My mission is to create a positive and lasting impact. Let’s journey together towards a future where science not only fuels our passion but also transforms lives.
We are Hiring
Manager,
Clinical Quality Assurance
for
Manager, Clinical Quality Assurance
Waltham, Massachusetts
Responsible for execution and performance of Lantheus CQA quality system elements including GCP audit programs, regulatory inspection preparation support, continuous improvement, and quality system procedural documents. Interface with internal and external customers to assess and support compliance with ICH-GCP, cGLP, applicable regulations, and global quality standards.
Position Responsibilities
- Serve as the CQA lead for assigned trials and assigned compliance areas ensuring the timely communication of quality risk and compliance as related to GCP/cGLP.
- Development and execution of a risk-based clinical quality audit plan for assigned programs.
- Audit internal processes, clinical investigator sites, and vendors to assess compliance with applicable regulations/guidelines and evaluate accuracy and quality of scientific data.
- Analyze and trend audit observations, gaps, and systematic issues to support continuous improvement within pre-clinical/clinical development programs, vendors, and cross-functional groups.
- Evaluate adequacy and completeness of CAPAs originated from audits, deviations, and/or inspections and perform effectiveness checks.
- Author audit reports and coordinate supporting documentation; manage same in QMS.
- Peer review reports authored by colleagues.
- Identify non-compliance trends and systematic risks for assigned areas of responsibility.
- Contribute to the development, maintenance, and continuous improvement of the quality system processes, tools, and E-Systems.
- Support the conduct of mock inspections and related activities; provide inspection preparation training to internal staff, clinical investigator sites, and vendors.
- Support Quality Management by facilitating regulatory agency inspections and related activities.
Basic Requirements
- Bachelor’s degree in a scientific discipline and 3 to 7 years’ experience in the pharmaceutical or biotech industry with 2 to 5 years in Clinical Quality Assurance. Clinical Operations on site experience (ie. CRA) is a plus.
- Full understanding of ICH GCP and appliable CFR regulations with a working knowledge of cGLP.
- Experience in risk-based quality management systems and quality by design in Phase I thru IV clinical trials.
- Experience in conducting internal and external GCP audits (i.e., Investigational Site Audits, Process Audits, Vendor Audits etc.), authoring audit reports, managing resulting CAPA process.
- Ability to manage processes with continuous improvement approach.
- Analytical and critical thinking skills.
- Experience developing SOPs and Work Instructions, reviewing internal clinical, regulatory, biometric, and medical processes to ensure they are accurately represented in current SOPs.
- Oncology and/or medical imaging clinical development experience is a plus.
- Diplomatically work and collaborate at all levels within the organization with discretion.
- Effective communication, planning, coordination, and time management skills.
- Up to 20% travel primarily in North America and Canada.
- This position is site-based and requires a presence on-site three days per week
Know About
About
Lantheus
Lantheus is recognized as an entrepreneurial and agile organization dedicated to delivering innovative diagnostics, targeted therapeutics, and AI solutions. Their cutting-edge technologies empower clinicians to find, fight, and follow diseases effectively. Guided by a strong set of purposes and values, Lantheus fosters behaviors in all interactions that contribute significantly to their dynamic and successful environment.
The company emphasizes the importance of each employee, promoting a culture of respect and unity with the understanding that they play a crucial role in someone’s health. Lantheus is committed to helping individuals achieve their best and strives to bring together a diverse group of professionals with varied perspectives and skills. This diversity is key to creating a productive and inclusive team.
Product
Pipeline
Lantheus Holdings, Inc. is a global leader in developing, manufacturing, and commercializing diagnostic and therapeutic products designed to aid clinicians in diagnosing and treating heart conditions, cancer, and other diseases. Their portfolio includes:
- DEFINITY: An ultrasound enhancing agent used in echocardiography exams.
- TechneLite: A technetium generator for nuclear medicine.
- Xenon-133: Utilized to assess pulmonary function.
- Neurolite: Identifies brain areas where blood flow is blocked or reduced due to stroke.
- Cardiolite: An injectable Tc-99m-labeled imaging agent.
- PYLARIFY: Visualizes lymph nodes, bone, and soft tissue metastases to determine the presence or absence of recurrent and/or metastatic prostate cancer.
Notable
Articles
- Lantheus Acquires NAV-4694, a Next-Generation ß Amyloid PET Imaging Agent for Alzheimer’s Disease
- Lantheus Welcomes CMS’ Proposed CY25 Rule for Improved Payment for Specialized Diagnostic Radiopharmaceuticals to Support Patient Access
- Lantheus Acquires Global Rights to Life Molecular Imaging’s Novel Therapeutic and Diagnostic Pair Targeting GRPR for Prostate and Breast Cancers
- Lantheus Announces the FDA Approval of DEFINITY® (Perflutren Lipid Microsphere) for Pediatric Patients
- Lantheus and POINT Biopharma Announce Positive Topline Results from Pivotal SPLASH Trial in Metastatic Castration-Resistant Prostate Cancer
We work with you to uncover your career goals and talents to find the ideal fit.
Contact Christina Cagle
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