The Opportunity:

Notable Labs seeks a Director / Sr. Director of Compliance and Quality Operations reporting to the VP of Operations to oversee the quality management program for the company. The person will ensure the testing services that Notable Labs provides are fit for purpose and meets the company’s Quality standard according to SOPs, client requirements and various regulatory requirements. As the Quality leader for Notable Labs, you will drive for continuous improvement in the organization and maintain compliance status for the various BSL-2/Bloodborne pathogen Notable lab departments: Research Use Only (RUO), CLIA, and Clinical Trial.

Responsibilities include:

  • Implement the following in a use-appropriate manner across the 3 department labs:
    • OSHA Act 1970 for Bloodborne Pathogens and BSL-2 lab
    • 29 CFR 1910, Bloodborne Pathogens
    • Data Integrity, 21 CFR Part 11
    • Applicable Parts of 21 CFR Part 58 for lab operation (i.e. Instrument, Quality group – not an animal GLP laboratory)
    • HIPAA, 45 CFR Parts 160 & 164
    • CLIA Lab Only, 42 CFR Part 493: CAP Accreditation & California Business Professions Compliance
    • RUO & Clinical Trial Labs: Design Control / History File, 21 CFR 820
    • Clinical Trial Labs:  21 CFR Parts 210 & 211 (not for Phase 1)
  • Develop a Quality Management System across the company to support training, change control, investigations, CAPAs, and client notifications.
  • Direct and Maintain training for company.
  • Oversee change control process and investigations, CAPAs, and client notification of alerts.
  • Ensure vendor management program and procurement policies are in compliance with regulatory expectations.
  • Execute a risk strategy and lead coordination of ongoing activities, assessments and mitigation, with other functional unit heads.
  • Ensures compliance will all applicable standards for material control for storage, shipping and handling.
  • Conduct Internal audits and external audits as required.
  • Represent the Quality department for all clients and the company’s staff and management meetings.
  • Build focus on customer service with the company and outside the company with customers and partners.
  • In support of the quality system, provide effective leadership support, training and guidance to all company personnel.
  • Support new product development by ensuring a quality design and assurance strategy for new product development and sustaining business activities.
  • Ensures alignment of corporate safety stature with applicable local, state, and federal standards.
  • Responsible for company’s overall safety management program.
  • Demonstrate compliance with all the company’s SOP’s, administrative policies and procedures, and governing authorities’ regulations at all times.
  • Demonstrate a high level of knowledge of Quality Management principles and laboratory and pharmaceutical regulatory compliance.

Qualifications:

  • Bachelor’s degree in a Life Science, Healthcare, or Quality Management discipline, Master or Ph.D. preferred.
  • Minimum of 15 years’ experience in a quality assurance/management position (drug &/or device)
  • Experience with working with a BSL-2 lab handling bloodborne samples.
  • Strong computer skills essential with LIMS and computer validation experience.
  • Knowledgeable of quality management systems and principles with a proficiency of phase and product appropriateness.
  • Understanding of software such as MediaLabs, Titan, and Jira are helpful yet not mandatory.
  • Understanding of flow cytometry is not a requirement.