Director, Quality Systems
3 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 Role
This role is responsible for leading Lantheus’ Quality Systems & Compliance team. This role will oversee the global compliance function and related processes, providing multi-site oversight of laboratory, manufacturing, and distribution operations. Manages and provides direction to Quality Systems, Compliance and Product Quality Complaints staff, ensuring that processes and activities are performed in compliance with company policies, procedures, standards and applicable local, state, federal, and international regulations governing drug products and medical devices. This role will partner with various internal and external cross-functional teams as well as external regulatory and auditing agencies.
Key Responsibilities/Essential Functions
- Oversees the management of the Quality Systems & Compliance team supporting product quality complaints, post market surveillance, Annual Product Quality Reports, field alerts, recalls, internal audit program, inspection readiness and external audits / inspections, Compliance Surveillance, Quality metrics, and Quality Management Review (QMR).
- Process owner for Quality Systems Management processes including Quality Events, Deviation, Non-Conformance, CAPA, Change Control, Complaint Investigations, Document Control, and Training. Lead or actively participate in implementation of updates and enhancements to these processes.
- Provide project and Subject Matter Expert support for all activities involving modifications, upgrades and or business process changes related to Quality Systems tools and applications.
- Develop and implement ways to improve Quality Systems business processes and strategies, which increase efficiency, improve compliance, and reduce system maintenance requirements.
- Partner with the IT organization to manage initiatives related to Quality Management Systems.
- Responsible for inspection readiness and manage regulatory inspection processes relating to cGMP including, but not limited to, FDA, MHRA, EMA, Health Canada, and Notified Body, across multiple sites. Provides corporate training on inspection readiness, inspection process and best practices. May act as key liaison for local, state, federal, and global regulatory agency inspections.
- Develops and manages the internal auditing program to ensure a constant state of compliance. Plans and executes compliance audits of internal operations as they relate to GxPs to ensure compliance with policies, procedures, and regulatory requirements; drives timely completion of associated corrective actions. Track and trend multi-site compliance issues to assure alignment with corporate standards.
- Responsible for the Compliance Surveillance program, tracking and trending new and changed regulations, agency guidance documents, industry standards, etc., identifying impact to Lantheus and driving resolution to close gaps.
- Respond in a timely manner to compliance concerns and contribute to problem resolution.
- Responsible for the drug Product Quality Complaint and medical device Post Market Surveillance processes, activities, and teams, including Field Actions and Recalls. Drives formal submission of FDA Field Alert Reports (FAR) and medical device reporting.
- Provides quality compliance oversight of Pharmacovigilance (PV) to ensure Adverse Event, complaint management and post market surveillance are executed compliantly and in a timely manner.
- Manages the creation and maintenance of compliance metrics, development of trend data of audit / inspection observations and communication of results expediently to applicable groups.
- Identify areas of improvement and participate in process improvement initiatives. Implements quality and process improvements evaluating multiple perspectives. Create new processes aimed at continual improvements, supporting a LEAN company culture. Manage multiple projects, realigning resources, and priorities to meet challenging timeframes.
- Responsible for driving functional excellence though the tactical execution of improvement activities.
- Manages the range of performance management processes for direct reports. Contributes to budgetary processes, including efficiency opportunities, in collaboration with leadership.
- Manage the budgeting process for the Quality Systems & Compliance function, and ensure expenditures align with budget.
- Other duties as assigned.
Basic Qualifications
- Bachelor’s degree in a related medical, science or business discipline and minimum 15+ years’ functional experience in Quality, Regulatory or comparable compliance discipline within the pharmaceutical, biopharmaceutical, medical device, or equivalent industries; or equivalent combination of education and experience.
- Demonstrated proficiency and knowledge of cGMP, ICH, and other US and worldwide regulatory requirements.
- Previous people management and/or team leadership experience required.
- Demonstrated cross functional leadership skills, with ability to lead and develop teams.
Other Requirements
- Strong planning and project management skills; demonstrated ability to influence and gain commitment from others.
- Excellent verbal, written and presentation skills at all levels both internally and externally, including regulatory bodies as well as customers.
- Ability to communicate effectively at all levels of the organization, as well as teach and present complex and/or new ideas with clarity and simplicity.
- Must be detail oriented with the ability to multitask and respond to ever changing priorities.
- Ability to work independently, influence with or without authority, facilitate groups with diverse perspectives and bring teams to consensus/alignment.
- This role is expected to be onsite in Billerica/Bedford, MA a minimum of 3 days per week.
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.
#LI-HYBRID
-
Product Line Director, Software
5 days ago
Billerica, United States OSI Systems, Inc. Full timeOverviewRapiscan Systems, an OSI Systems Company is seeking a Product Line Director, based out of Billerica, MA.We are proud to be a trusted provider of advanced X-ray technologies for ports, borders, military, high-threat facilities and critical infrastructure all over the world. Be a part of our mission to provide our customers with best-in-class cargo and...
-
Head of Quality Systems and Compliance
1 week ago
North Billerica, United States Lantheus Medical Imaging Inc Full timeJob OverviewLantheus Medical Imaging Inc. is a leader in the medical imaging sector, with a rich history of over 60 years in enhancing patient care through innovative diagnostic solutions. Our organization is dynamic and rapidly evolving, dedicated to providing cutting-edge diagnostics, targeted therapies, and AI-driven solutions that empower healthcare...
-
Head of Quality Systems
2 weeks ago
North Billerica, United States Lantheus Medical Imaging Inc Full timePosition OverviewLantheus Medical Imaging Inc. is a leading organization in the field of medical imaging, dedicated to enhancing patient care through innovative diagnostics and therapeutics. With a rich history spanning over 60 years, we pride ourselves on our entrepreneurial spirit and commitment to excellence.Role SummaryThe individual in this pivotal role...
-
Head of Quality Systems and Compliance
2 weeks ago
North Billerica, United States Lantheus Medical Imaging Inc Full timePosition OverviewLantheus Medical Imaging Inc., a leader in the medical imaging sector, is seeking a dynamic individual to spearhead our Quality Systems & Compliance team. With a legacy of over 60 years, Lantheus is dedicated to enhancing patient care through innovative diagnostics and therapeutic solutions.Role SummaryThe selected candidate will be pivotal...
-
Quality Management Systems Specialist
2 weeks ago
Billerica, Massachusetts, United States Lantheus Full timeCompany OverviewLantheus is a leading organization in the medical imaging sector, dedicated to enhancing patient care through innovative diagnostics and therapeutics. With a presence in multiple countries, we pride ourselves on our entrepreneurial spirit and commitment to quality.Position SummaryWe are seeking a dynamic and experienced Business Analyst to...
-
Associate Director, Quality Compliance
2 days ago
North Billerica, Billerica, MA , USA, United States Lantheus Medical Imaging Inc Full timeJob SummaryLantheus Medical Imaging Inc is seeking a highly experienced Associate Director, Quality Compliance to provide leadership and compliance oversight for the company's in-house and contract manufacturing activities and processes.Key ResponsibilitiesManage the internal audit program, inspection readiness, and external audits/inspections to ensure...
-
Associate Director, Quality Compliance
3 months ago
North Billerica, United States Lantheus Medical Imaging Inc Full timeJob DescriptionJob DescriptionLantheus 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...
-
Senior Mechanical Quality Inspector
2 weeks ago
Billerica, Massachusetts, United States Connexion Systems & Engineering, Inc. Full timeJob OverviewWe are seeking a Senior Mechanical Quality Inspector to join our team at Connexion Systems & Engineering, Inc. This role involves conducting precise metrology inspections utilizing advanced equipment such as CMM and OGP Smartscopes. The successful candidate will be responsible for performing first article inspections and incoming quality...
-
Quality Management Systems Administrator
1 hour ago
Billerica, Massachusetts, United States AS&E Full timeJob Description**Job Summary:**We are seeking a highly skilled Quality Management Systems Administrator to join our team at AS&E. The successful candidate will be responsible for ensuring the effective implementation and maintenance of our quality management system, ensuring compliance with industry standards and regulations.Key Responsibilities:Assist in...
-
Optical Systems Testing Specialist
1 week ago
Billerica, Massachusetts, United States FLIR Commercial Systems Inc (US) Full timeThis position focuses on the evaluation of opto-mechanical systems in accordance with production specifications, utilizing a variety of hand tools, measurement instruments, and testing apparatus.Company Overview:FLIR Commercial Systems Inc is a prominent provider of advanced sensing technologies, dedicated to upholding the highest ethical standards in its...
-
Quality Technician
4 weeks ago
North Billerica, United States SI2 Technologies Inc Full timeCompany Summary ARA is a leading C5ISR company that designs, manufactures, tests and installs innovative technologies that provide the national security community with unparalleled situational awareness, threat detection, and communications capabilities. Our disruptive, integrated solutions, assemblies and subsystems rise to the challenging demands of...
-
Quality Assurance Specialist
3 days ago
north billerica, United States Randstad Life Sciences US Full timeJob SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team at Randstad Life Sciences US. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our products and processes.Key ResponsibilitiesPerform routine and non-routine testing and analysis of incoming materials, in-process products, and...
-
Quality Assurance Specialist
2 days ago
North Billerica, United States Randstad Life Sciences US Full timeJob SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team at Randstad Life Sciences US. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our products and services.Key ResponsibilitiesPerform routine and non-routine testing and analysis of materials, products, and processes to ensure...
-
Quality Technician
4 weeks ago
North Billerica, United States Antenna Research Associates Inc Full timeJob DescriptionJob DescriptionCompany Summary ARA is a leading C5ISR company that designs, manufactures, tests and installs innovative technologies that provide the national security community with unparalleled situational awareness, threat detection, and communications capabilities.Our disruptive, integrated solutions, assemblies and subsystems rise to the...
-
Quality Control Manager
2 months ago
North Billerica, United States BNZ Materials, Inc Full timeJob DescriptionJob DescriptionJob Summary:The Quality Control Manager is responsible for overseeing all aspects of the quality control function to ensure product quality and compliance with industry regulations. This includes developing and implementing quality control systems and coordinating with other departments to achieve company quality...
-
Quality Assurance Specialist
2 weeks ago
North Billerica, United States Antenna Research Associates Inc Full timeJob OverviewCompany OverviewAntenna Research Associates, Inc. is a prominent C5ISR organization that innovates, fabricates, evaluates, and deploys advanced technologies aimed at enhancing national security through superior situational awareness, threat detection, and communication systems.Our cutting-edge, integrated solutions, assemblies, and subsystems are...
-
Quality Assurance Specialist
1 week ago
North Billerica, United States SI2 Technologies Inc Full timeCompany OverviewSI2 Technologies Inc. is a prominent firm specializing in C5ISR solutions, dedicated to designing, producing, testing, and implementing advanced technologies that offer unmatched situational awareness, threat detection, and communication capabilities for the national security sector. Our innovative, integrated solutions, assemblies, and...
-
Quality Engineer
1 month ago
North Billerica, United States Lantheus Medical Imaging Inc Full timeJob DescriptionJob DescriptionLantheus 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...
-
Senior Quality Control Analyst
2 weeks ago
North Billerica, United States Lantheus Medical Imaging Inc Full timePosition: Quality Control Laboratory AnalystLantheus Medical Imaging Inc, a prominent entity in the medical imaging sector, is in search of a Quality Control Laboratory Analyst to execute both standard and advanced assessments on incoming materials within the QC Laboratory. This role is vital to our operations, and the selected candidate will significantly...
-
Quality Assurance Specialist
1 week ago
North Billerica, United States SI2 Technologies Inc Full timeCompany OverviewSI2 Technologies Inc. is a prominent C5ISR organization that innovates, fabricates, tests, and deploys advanced technologies, delivering exceptional situational awareness, threat detection, and communication solutions to the national security sector. Our groundbreaking, integrated solutions, assemblies, and subsystems are designed to meet the...