Quality Manager

Lighthouse Instruments

LIGHTHOUSE is the leading global provider of laser-based, non-destructive headspace analysis platforms, Our range of benchtop and in-line platforms with patented laser sensor technology is used to analyze pharmaceutical products and packages and monitor sterile product processes across the product life cycle.

In addition to supplying headspace platforms, LIGHTHOUSE offers measurement services and lease equipment from laboratory facilities in Charlottesville, VA, and Amsterdam. Our highly-trained team of Application Scientists supports customers with outsourced testing services, scientific studies, and lease equipment projects.

Lighthouse Instruments is currently seeking an experienced Quality Manager to join our talented team.

The Quality Manager is primarily responsible for establishing and maintaining quality systems for the analytical services business unit, providing quality oversight to assigned areas, and supporting quality systems for the product manufacturing business unit. This position will perform all duties associated with compliance-related items for ISO standards and cGMPs.

At Lighthouse Instruments (LHI), we consider our talented team to be our greatest asset. Their health and wellness are vital to the success of our organization. That’s why, as part of our Total Rewards strategy, we offer affordable and comprehensive healthcare coverage with ancillary benefit options to eligible employees and their families beginning the first day of the month following the hire date.

Additionally, LHI offers a variety of benefits focused on the professional development, financial, and well-being of our employees. Our benefits package includes several Medical options, Dental and Vision insurance, Life and AD& D, Voluntary Life, and Disability Insurance. Our Wellness benefits include Mental Health, Employee Assistance Programs (EAP), Fitness & Health Programs, Parental Leave, PTO, and Work-Life Balance such as flex-time. LHI also offers generous Tuition Assistance, Company Matching Retirement, Discretionary Bonus potential, Travel Insurance, and much more.

Key Responsibilities

  • Actively drive quality initiatives to achieve company initiatives and ensure compliance with customer needs and expectations
  • Analyze data, process capabilities, customer concerns and expectations, and any other leading or lagging indicators, which may be used to improve product and process knowledge
  • Performs internal audits to ensure compliance with established procedures and identify quality system weaknesses that need improvement
  • Manage the CAPA process, including the review and approval to open new CAPAs and approving CAPA plans, timelines, and verification of effectiveness plans to ensure timely completion within the established goal
  • Lead investigation and root cause analysis of internal deviations and non-conformance reports
  • Provides expertise and guidance to site personnel using root cause analysis tools for investigations and continuous improvements
  • Assists with process, documents, procedures, and forms changes as needed
  • Oversee equipment validation and calibration activities
  • Perform internal quality systems audits in accordance with ISO standards, including recommending ways to resolve any issues identified by the audits
  • Participates in all customer audits (onsite and paper audits.)
  • Performs other duties as required or assigned

Experience and Qualifications


  • Bachelor’s degree in one of the life sciences
  • 5+ years of Quality related experience in a laboratory environment, preferably cGMP
  • Knowledge of ISO 9001, ISO 17025, and cGMPs

Success Factors:

  • Possess above-average attention to detail with a close observation of accuracy
  • Self-motivated with a desire to succeed & drive organizational improvements
  • Customer service oriented both internally and externally
  • Proactive, adheres to deadlines, and responsive to management requirements
  • Active listening and clear communication skills: verbal, written, and presentation skills (e.g., grammar, writing, and editing) to interact professionally with individuals, internally with co-workers, and externally with vendors and customers required
  • Effective problem analysis and resolution skills
  • Above-average interpersonal and relationship skills are essential, with the ability to handle sensitive situations with poise, tact, and diplomacy
  • Above average ability to be flexible, organize, manage time, and set/shift priorities while meeting deadlines required
  • A team player who can cultivate a team spirit within the department and maintain positive interdepartmental collaboration
  • Ability to interpret, adapt, and apply Organization guidelines and procedures within the position and the department
  • A team player who can cultivate a team spirit within the department and maintain positive interdepartmental collaboration



Job Type



  • Dental
  • Vision
  • PTO
  • Tuition Assistance


2050 Avon Court, Charlottesville, VA 22902

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