The Director of Quality will develop, implement, and periodically evaluate a program to ensure the Sombra’s production operations, from raw materials to finished products, meet the quality, integrity, and efficiency standards set by Sombra and comply with FDA cGMP standards.

Supervisory Responsibilities:

  • Directs and oversees the quality control department and supervisory staff.
  • Conducts performance evaluations that are timely and constructive.
  • Handles discipline and termination of employees in accordance with company policy.

Duties/Responsibilities:

  • Evaluates production operations from a strategic level to ensure that products meet cGMP for quality, integrity, functionality, and other specifications and requirements.
  • Processes regulatory accreditation, renewals, and organizational compliance.
  • Collaborates with management and senior staff across production departments and roles to draft acceptable quality standards.
  • Develops and implements quality standard testing and evaluation processes.
  • Facilitates communication among production divisions and management.
  • Assesses laboratory test results and approves compliance of materials and products.
  • Reviews quality control documentation such as SOPs, checklists, logs, and reports for effectiveness, accuracy, and relevance.
  • Conducts random inspections and quality control checks.
  • Periodically reports status of quality control and operations to executive leadership and, when required, regulatory agencies.
  • Performs other related duties as assigned.

Required Skills/Abilities:

  • Excellent verbal and written communication skills with the ability to train staff.
  • Thorough understanding of quality control standards and methodologies.
  • Thorough understanding of manufacturing and production in the industry.
  • Excellent organizational skills and attention to detail.
  • Strong analytical and problem-solving skills.
  • Strong supervisory and leadership skills.
  • Proficient with Microsoft Office Suite or related software.

Education and Experience:

  • Bachelor’s degree in related industrial, scientific, or business field required; Master’s degree preferred.
  • Eight to 10 years of related experience required with at least five years as a quality manager or similar role highly preferred.

Physical Requirements:

  • Prolonged periods sitting at a desk and working on a computer.
  • Must be able to lift up to 15 pounds at times.

*Equal Opportunity Employer