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Associate Director, Quality Control

Associate Director, Quality Control

LantheusNorth Billerica, MA, United States
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Description

Lantheus is headquartered in Bedford, Massachusetts with offices in 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.

This position is site-based and requires a presence on-site 5 days per week.

Summary of role

We are seeking an experienced Associate Director Quality Control to lead analytical laboratory operations supporting pharmaceutical manufacturing and product development. The ideal candidate is a proactive leader with strong technical expertise, comprehensive understanding of industry practices, regulatory requirements, and a commitment to safety, quality and continuous improvement.

Key Responsibilities / Essential Functions

Strategic Leadership & Operational Oversight

  • Develop and execute strategic plans for the QC function, leveraging expertise to drive decisions that align with business objectives.
  • Manage departmental goals to ensure reliable product supply, adherence to company policies, and successful project execution.
  • Oversee budgeting, scheduling, and performance standards to support operational efficiency and compliance.

Laboratory Management

  • Ensure all aspects of laboratory operations are effectively managed, including training, scheduling, inventory, equipment maintenance / calibration, and safety.
  • Maintain validated methods and qualified equipment, ensuring all QC testing and data management activities comply with SOPs, cGMPs, and regulatory standards.
  • Monitor performance metrics and trends to identify opportunities for improvement.

    • Systems & Technology

  • Ensure effective use of electronic systems such as ERP, QMS, LIMS, and lab equipment software.
  • Serve as system administrator or alarm notification contact for area-specific software and monitoring systems.

    • Team Development & Performance

  • Build and manage a high-performing team through effective staffing, training, performance reviews, and workload balancing.
  • Foster a culture of continuous improvement, compliance, and technical excellence.
  • Develop and implement employee development plans to enhance skills, support succession planning, and mitigate operational risks.

    • Cross-Functional Collaboration

  • Act as a liaison with other departments and management levels to support operational decisions and strategic planning.
  • Lead team meetings, facilitate VPM efforts, participate in GEMBA walks, and apply Lean / Project Management tools.

    • Policy & Compliance

  • Establish and interpret operating policies and procedures for the QC function.
  • Ensure inspection readiness and compliance with global regulatory requirements (e.g., FDA, USP / EP / JP).
  • Interface with regulatory inspectors and internal auditors, ensuring timely resolution of commitments.

    • Quality Systems Management

  • Oversee timely and effective use of QMS tools including training, investigations, deviations, CAPAs, SOP revisions, change controls, and protocols.
  • Serve as lead investigator, SOP owner, change control author, or protocol study lead as needed.
  • Resolve complex technical and compliance issues independently, leveraging internal and external expertise.

    • Safety & Environmental Stewardship

  • Promote and enforce safety protocols, ensuring proper use of protective equipment and safe handling of hazardous materials.
  • Proactively identify and address safety and environmental risks within the laboratory environment.

    • Basic Qualifications

  • 10 years' experience with a BS of progressively more responsible laboratory management in a related scientific / technical discipline or equivalent combination of education and relevant experience in the pharmaceutical industry, related GMP environment, or equivalent.
  • Deep understanding of QC operations, regulatory requirements, and industry best practices with proven leadership in managing complex laboratory environments and cross-functional teams.
  • Recognized as a subject matter expert within the organization, with the ability to solve advanced problems and guide others.
  • Other Requirements
  • Flexibility with scheduling requirements for staff and manage support to include evenings, weekends, shifts, and holiday coverage, including during adverse weather conditions.
  • Manage and direct staff who work with (or in proximity to) potentially hazardous chemical, radiological, and or biological materials and who must be able to lift / move a variety of materials, e.g. portable equipment, lead, gas cylinders, bottles of chemicals, waste containers.

    • 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 an equal opportunity employer that provides a workplace free from discrimination. All qualified applicants and employees are considered without regard to race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any other characteristic protected by 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 .

    Equal Opportunity Employer

    This employer is required to notify all applicants of their rights pursuant to federal employment laws.

    For further information, please review the Know Your Rights notice from the Department of Labor.

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    Quality Control Associate • North Billerica, MA, United States

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