Quality Compliance Manager

2 weeks ago

Billerica, United States Lantheus Full time
Description

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 providing leadership and compliance oversight for Lantheus‘ in-house and contract manufacturing activities and processes. This individual will own the internal audit program, inspection readiness and external audits / inspections, Compliance Surveillance, Quality metrics, Quality Management Review (QMR), and other compliance activities as assigned. The individual will interface with cross-functional teams, 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 closely interact with cross-functional colleagues across multiple sites.

Key Responsibilities/Essential Functions

  • Acts as a Subject Matter Expert on applicable standards and regulations for the organization.
  • Manages inspection readiness and manages 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.
  • 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.
  • Manages 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.
  • 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 participates in process improvement initiatives. Implements quality and process improvements evaluating multiple perspectives. Creates new processes aimed at continual improvements, supporting a LEAN company culture. Manages multiple projects, realigning resources and priorities to meet challenging timeframes.
  • Contributes to budgetary processes, including efficiency opportunities, in collaboration with leadership.
  • Other duties, projects and activities as assigned.

Basic Qualifications

  • Bachelor‘s degree in a related medical, science or business discipline and minimum 7+ 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.
  • Minimum 5+ years in auditing role.
  • Demonstrated proficiency and knowledge of cGMP, ICH, and other US and worldwide regulatory requirements.
  • This position is site-based and requires a presence on-site four days per week.

Other Requirements

  • Solid planning and project management skills; ability to influence and gain commitment from others.
  • Good verbal, written and presentation skills at all levels both internally and externally.
  • Ability to communicate effectively at a variety of levels of the organization, as well as coach and mentor members of GxP functions on compliance requirements and topics.
  • Must be detail oriented with the ability to multitask and respond to ever changing priorities.
  • Ability to work independently and drive on time completion of responsibilities and assigned tasks.
  • 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 .





  • Quality Compliance Manager

    1 month ago

    North Billerica, United States Lantheus Medical Imaging Inc Full time

    Job SummaryLantheus Medical Imaging Inc is seeking a highly skilled Quality Compliance Manager to provide leadership and compliance oversight for our in-house and contract manufacturing activities and processes. This role will own the internal audit program, inspection readiness, and external audits/inspections, as well as Compliance Surveillance, Quality...

  • Senior Manager, Quality

    3 weeks ago

    Billerica, United States Access Vascular Inc Full time

    Job Description We are seeking a highly skilled and experienced Senior Manager, Quality to support our Manufacturing Quality team. This role is critical in ensuring that our products meet the highest standards of quality and compliance. The ideal candidate will have a strong background in quality management within the medical device industry and a proven...

  • Quality Management Systems Administrator

    4 weeks ago

    Billerica, Massachusetts, United States Rapiscan Systems Full time

    Job Title: Quality Management Systems AdministratorJob Summary:Rapiscan Systems is seeking a Quality Management Systems Administrator to join our team. As a Quality Management Systems Administrator, you will be responsible for the administration of the maintenance and compliance with the company's integrated quality & environmental management system...

  • Quality Management Systems Administrator

    4 weeks ago

    Billerica, Massachusetts, United States Rapiscan Systems Full time

    Rapiscan Systems is seeking a Quality Management Systems Administrator to join our team 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.As a Quality Management Systems Administrator, you will assist with the...

  • Senior Manager, Quality Assurance

    4 weeks ago

    Billerica, Massachusetts, United States Access Vascular Inc Full time

    Job Title: Senior Manager, Quality AssuranceAbout the Role:We are seeking a highly skilled and experienced Senior Manager, Quality Assurance to support our Manufacturing Quality team. This role is critical in ensuring that our products meet the highest standards of quality and compliance.Key Responsibilities:Lead and manage the Manufacturing Quality team to...

  • Quality Assurance Associate

    5 days ago

    Billerica, United States FootBridge Company Full time

    Position Title: Quality Assurance Associate Pay Rate: $20/hr. Schedule: 8:00 am – 5:00 pm Location: Billerica, MA Experience Required: 1-2 years Job Description: The Quality Assurance Associate supports the Quality Manager in maintaining the quality management system, ensuring compliance with ISO standards, and meeting applicable regulatory...

  • Senior Quality Assurance Consultant

    4 weeks ago

    Billerica, Massachusetts, United States Actalent Full time

    Job Title: Sr. Quality Assurance ConsultantJob DescriptionAs a Senior Quality Assurance Consultant, you will serve as a Subject Matter Expert on applicable standards and regulations for the organization. Your key responsibilities will include driving inspection readiness and improvement to regulatory inspection processes relating to cGMP, including FDA,...

  • Quality Assurance

    2 weeks ago

    Billerica, United States Lantheus Full time

    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 organization that...

  • Associate, QC Compliance

    5 months ago

    Billerica, United States Sun Pharma (Taro Pharma) Full time

    Job Summary The Associate Quality Control - Compliance role is a dual function role. The role is divided between QC compliance activities and QC laboratory GMP testing activities. Performs various quality control tests on raw materials, in-process and final product using approved test methods, Standard Operating Procedures (SOPs) and works in accordance...

  • Associate, QC Compliance

    4 months ago

    Billerica, United States Sun Pharmaceutical Industries, Inc. Full time

    Job Summary The Associate Quality Control - Compliance role is a dual function role. The role is divided between QC compliance activities and QC laboratory GMP testing activities. Performs various quality control tests on raw materials, in-process and final product using approved test methods, Standard Operating Procedures (SOPs) and works in accordance...

  • Associate, QC Compliance

    4 weeks ago

    Billerica, United States Sun Pharmaceutical Industries, Inc. Full time

    Job SummaryThe Associate Quality Control - Compliance role is a dual function role. The role is divided between QC compliance activities and QC laboratory GMP testing activities. Performs various quality control tests on raw materials, in-process and final product using approved test methods, Standard Operating Procedures (SOPs) and works in accordance with...

  • Supplier Quality Program Manager

    2 weeks ago

    Billerica, United States E Ink Full time

    Team up with the most innovative company where Imagination becomes reality!E Ink is the originator, pioneer and commercial leader in ePaper technology (see E InkAbout Us).We are seeking qualified candidates who are self-driven, looking to advance their career and be a high-impact player on a team. Our diversity of people, backgrounds, experiences, thoughts...

  • Associate, QC Compliance Specialist

    4 weeks ago

    Billerica, Massachusetts, United States Sun Pharmaceutical Industries Inc. Full time

    Job SummaryThe Associate Quality Control - Compliance role is a dual function position at Sun Pharmaceutical Industries Inc. The role is divided between QC compliance activities and QC laboratory GMP testing activities. Performs various quality control tests on raw materials, in-process and final product using approved test methods, Standard Operating...

  • Quality Assurance Auditor

    2 weeks ago

    Billerica, United States Parexel International Corporation Full time

    Home Based, USThe Quality Assurance (QA) Auditor II will have experience and knowledge of appropriate GxP compliance and other applicable regulations and laws, Parexel procedures and appropriate Parexel processes, which allows the individual to plan and conduct internal and external audits independently, or with minimal supervision. Provide advice on...

  • Quality Assurance Auditor

    2 weeks ago

    Billerica, United States Parexel International Corporation Full time

    Home Based, USThe Quality Assurance (QA) Auditor II will have experience and knowledge of appropriate GxP compliance and other applicable regulations and laws, Parexel procedures and appropriate Parexel processes, which allows the individual to plan and conduct internal and external audits independently, or with minimal supervision. Provide advice on...

  • Associate, QC Compliance

    5 months ago

    Billerica, United States Sun Pharma (Taro Pharma) Full time

    Job DescriptionJob SummaryThe Associate Quality Control - Compliance role is a dual function role.  The role is divided between QC compliance activities and QC laboratory GMP testing activities.  Performs various quality control tests on raw materials, in-process and final product using approved test methods, Standard Operating Procedures (SOPs) and works...

  • Associate, QC Compliance

    2 months ago

    Billerica, United States Sun Pharmaceutical Industries, Inc. Full time

    Job SummaryThe Associate Quality Control - Compliance role is a dual function role.  The role is divided between QC compliance activities and QC laboratory GMP testing activities.  Performs various quality control tests on raw materials, in-process and final product using approved test methods, Standard Operating Procedures (SOPs) and works in accordance...

  • Associate, QC Compliance

    3 months ago

    BILLERICA, United States Disability Solutions Full time

    Job SummaryThe Associate Quality Control - Compliance role is a dual function role.  The role is divided between QC compliance activities and QC laboratory GMP testing activities.  Performs various quality control tests on raw materials, in-process and final product using approved test methods, Standard Operating Procedures (SOPs) and works in accordance...

  • Associate, QC Compliance

    5 months ago

    Billerica, United States Sun Pharma (Taro Pharma) Full time

    Job SummaryThe Associate Quality Control - Compliance role is a dual function role.  The role is divided between QC compliance activities and QC laboratory GMP testing activities.  Performs various quality control tests on raw materials, in-process and final product using approved test methods, Standard Operating Procedures (SOPs) and works in accordance...

  • Senior Quality Associate

    6 months ago

    Billerica, United States GENEWIZ Full time

    Company Overview At Azenta, new ideas, new technologies and new ways of thinking are driving our future. Our customer-focused culture encourages employees to embrace innovation and challenge the status quo with novel thinking and collaborative work relationships.  Azenta Life Sciences is a global leader in the life sciences space with headquarters in...