Direcotr/Senior Director, Quality Assurance

Statistics and Data Corporation

Waltham - Telecommute

Job Summary

Manage and drive all operational and strategic aspects of quality across the organization. Institute processes to ensure that all company personnel is trained and understand their responsibilities with respect to the QMS. This includes helping to ensure all employees adhere to all standard operating procedures, as applicable to their individual roles. Responsible for establishing quality goals and objectives and for establishing appropriate performance metrics to monitor for trends requiring analysis and corrective action.

Drive overall corporate quality with ultimate goals to a) Ensure compliance with relevant guidelines, regulations, and standards; b) Position SDC as the highest quality provider of CRO services; and, c) Ensure quality clinical conduct encourages repeat business from clients.

Primary Responsibilities

  • Enhance, maintain, and continuously improve SDC's QMS.
  • Lead, coach, train, and mentor assigned personnel.
  • Conduct internal audits for proper adherence to established procedures.
  • Serve as QMS subject matter expert (SME) in meetings, as required.
  • Develop quality goals and objectives and communicate the same to the management team.
  • Develop and deliver company-wide effective training on the QMS and SOPs.
  • Support business development and strategic planning activities, as required.
  • Conduct regular reviews with the Executive Management team at SDC of quality assurance-related metrics and lessons learned.
  • Oversee the preparation and maintenance of all quality-related documentation to include but not limited to standard operating procedures (SOPs) in support of the QMS.
  • Act as a quality assurance liaison with internal and external cross-functional teams, clients, and suppliers, as well as project team meetings, as required.
  • Develop and maintain quality assurance-related metrics to help the company understand how it is performing with respect to quality.
  • Help lead SDC's continuous improvement initiatives.
  • Conduct and manage the internal audit process to assess procedural and regulatory compliance.
  • Analyze quality metrics on a regular basis for performance trends requiring management attention.
  • Help prepare, revise, and control the company's SOP's.
  • Adherence to all essential systems and processes that are required at SDC to maintain compliance to business and regulatory requirements.

The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This document is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.

Requirements

  • Demonstrated management/supervisor-related experience.
  • Excellent leadership and management abilities.
  • Strong ability to motivate company personnel to adhere to quality policies and procedures.
  • Solid independent thinking ability and demonstrated ability to discern multiple viewpoints.
  • Working knowledge and understanding of ICH Guidelines for Good Clinical Practice and Title 21 of the Code of Federal Regulations.
  • Strong understanding of international regulations regarding clinical research (EMEA, PMDA, Health Canada, etc.).
  • Good analytical skills with the ability to evaluate data trends for lessons learned requiring action.
  • Demonstrated ability to conduct root cause analysis and to prepare written remediation plans.
  • Keen ability to accurately discern priorities in a resource-constrained work environment.
  • Demonstrated process auditing and improvement skills and aptitude.
  • Ability to effectively train and educate internal staff on procedures and regulatory issues.
  • Demonstrated ability to develop effective procedures and to write clear, consistent, thorough SOP's.
  • Experience working closely with FDA in either audit scenarios or through prior employment.
  • Excellent verbal and written communication skills.

Education or Equivalent Experience

  • Bachelor's degree in applied life science or business with at least eight (8) years of increasing experience in a related quality assurance position.
  • MBA or other related advanced degree is preferred.
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