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Laboratory Director - Quality Control

Employer
CBR, by Generate Life Sciences
Location
Tucson, AZ
Closing date
Sep 19, 2021

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Sector
Pharmaceutical, Laboratory, Quality Assurance
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Job Description

Looking to make a difference in the world?
If you're ready to help grow our cord blood business and expand market share... then we're looking for you!
We have an immediate opening at our Tucson, AZ facility for a Laboratory Director - Quality Control with
CBR, a Generate Life Sciences Company (Cord Blood Registry)

Purpose:

Responsible for directing activities that support and monitor the quality of CBR client products by overseeing daily operations in Quality Control (QC). Ensures compliance with all applicable regulations, standards, systems, procedures and practices.

Duties & Responsibilities:

Essential Duties and Responsibilities include the following; other duties may be assigned:
  • Ensure compliance to corporate policies, AABB and other regulatory and quality organizations and standards, and cGLP best practices.
  • Partner with Medical Director, Quality Assurance and Product Operations leadership to ensure on-going compliance and product quality.
  • Work with QC and product operations stakeholders to establish procedures and execute daily workload and projects.
  • Maintain an up-to-date knowledge of applicable federal and state regulations and guidelines.
  • Institute and maintain quality control, programs, including but not limited to, product sterility testing, environmental monitoring, long-term stability testing and in-process product quality control testing and monitoring.
  • Support Quality Assurance in addressing issues documented within the Quality Management System.
  • Ensures proper validation of all new or changed procedures, equipment, and processes that directly impact product quality prior to use in the facility.
  • Review and approve applicable validation data and summary reports.
  • Oversee the testing of equipment for proper operation.
  • Assists in design of experiments for Research and Development projects.
  • Provide leadership support for the strategic development of regulatory submissions and quality management policies and practices.
  • Participate on CBR's Quality Change Control Board, CAPA Review Board and Management Review Board.
  • Work with CBR's Medical and Technical Laboratory Director(s) to maintain laboratory proficiency/competency program.
  • Report out on product quality metrics no less than quarterly.
  • Perform job functions in fiscally responsible manner.
  • Perform duties associated with being a member of Lab Management team, including 'Manager on-call' responsibilities.
  • Responsible for the overall direction, coordination, and evaluation of QC team members.
  • Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws.
  • Responsibilities include interviewing, hiring and training team members; planning, assigning, and directing work; appraising performance; addressing complaints and resolving problems.

Basic Qualifications:
  • Master's degree in a life sciences discipline and a minimum of 5 years related laboratory experience
  • Or Bachelor's degree in a life sciences or engineering discipline and a minimum of 7 years related laboratory experience
  • 5 years of management experience as well as demonstrated leadership and technical experience.

Preferred Qualifications:
  • Previous Clean Room experience preferred
  • Previous experience with biological products in an FDA regulated environment.
  • Ability to clearly communicate information/ideas/recommendations (verbally and in writing) with technical, administrative and management personnel
  • Excellent written and oral communication skills in English language. Ability to read, analyze, and interpret the most complex documents.
  • Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems. Ability to deal with nonverbal symbolism (formulas, scientific equations, graphs, etc.) in its most difficult phases. Ability to deal with a variety of abstract and concrete variables.
  • Proven ability to mentor, develop, supports, and collaborates with staff.
  • Strong educator that can convey complex information and ideas easily.
  • Pro-active, strategic thinker who is results oriented while taking the long-term view.


Please Note : As a Life Sciences company, Generate and our brands are dedicated to protecting the health and safety of not only our clients and communities, but our employees as well. As such, all new employees with an expected hire date of August 9, 2021 or later must have received or be willing to receive the COVID-19 vaccine by their date of hire.
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