Quality Assurance Manager

4 weeks ago

Indianapolis IN 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 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
The Quality Assurance (QA) Manager provides functional and technical management to Quality Release personnel for external manufacturing operations.
The QA Manager participates in the development, implementation, and evaluation of processes, procedures, and applications with the overall objective of providing Quality oversight for routine manufacturing of aseptically filled, radiopharmaceutical products produced by Contract Manufacturing Organizations (CMO). Provide Quality Assurance technical expertise to ensure aseptic manufacturing, processes and support systems are in compliance with company guidelines and CGMP regulations for products and/or their raw materials, APIs, excipients or components.
The position is located in Indianapolis, Indiana for oversight of CMO-produced products in the Indianapolis area.
Key Responsibilities/Essential Functions

  • Function as the primary QA representative in oversight of routine CMO Manufacturing operations, including batch disposition, change management, investigation and CAPA review and approval, while adhering to regulatory, technical and business requirements.
  • Ensure staff members' activities and operations are in alignment with all internal policies and requirements, in compliance with all external regulatory requirements. Manage the activities and performance of direct staff; this includes hiring, training, developing, addressing performance issues and evaluating performance.
  • Develop action plans, initiate, and employ training/development programs and assignments to further enhance technical skills and overall competencies of staff members.


    • Provide quality oversight of CMO operations, by gathering and reviewing information from functional areas and identifying compliant solutions based on evidence utilizing a risk-based approach.
    • Collaborate with full range of personnel in manufacturing and technical work teams, both internal and external, that support Production to ensure product SISPQ are met.
    • Provide leadership and technical expertise in conducting CMO investigations by utilizing root cause analysis tools to determine root cause(s), implementing corrective and preventative actions (CAPA) to prevent reoccurrence and assessment of product/patient impact.
    • Serve as the primary Quality representative for management of CMO Supplier Change Notification records.
    • Represent QA in a range of team meetings, processes and initiatives both internally and with CMOs.
    • Function as the primary QA representative for CMO metric management, including trending, reporting and driving improvement.
    • Review and approve protocols, validation documents and procedures, both internally and externally.
    • Act as technical resource with the FDA and other government agencies during site inspections.
    • Alert management of critical issues that have significant impact to manufacturing objectives and timelines, while providing a range of achievable solutions.
    • Support Investigation Review Board and Change Control Review Board meetings as required.
    • Remain current and apply knowledge of FDA CFR 210/211 and other regulatory standards and guidance in the pharmaceutical industry.

      Basic Qualifications

      • BS/BA degree in a scientific discipline with minimum 7-10 years of progressive experience in the pharmaceutical or radiopharmaceutical industry or related GMP environment, or equivalent.

        Other Requirements

        • Aseptic fill-finish experience, including familiarity with validation of aseptic manufacturing technologies and facilities is preferred.
        • Previous lab experience in Manufacturing and/or Quality Control at aseptic processing facility is preferred.
        • Previous experience in Quality, Compliance and/or Manufacturing of radiopharmaceutical products is preferred.


          • Handling of and, or exposure to potentially hazardous chemical, radiological and or biological materials. Required to follow all safety procedures, and use personal and protective equipment provided.
          • Ability to travel up to 20%.

            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 .

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