Quality Assurance Director

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Job Description

As Director of the Quality function, this individual is primarily responsible for ensuring that the quality program is compliant with applicable regulatory requirements (GxPs) needed for the successful operations of the business.

* Leads the quality initiative for the company to comply with FDA GxP Regulations, EMEA and OECD as applicable

* Assures that the organizational facilities management, through oversight and internal auditing, is in compliance with pertinent regulatory requirements encompassing pharmaceutical drug testing (i.e. FDA GxP Regulations, OECD, as applicable).

* Responsible for quality teams existing KPIs and creating new KPIs for continuous improvement

* Responsible for adequate resourcing of the quality team as well as hiring, firing, performance reviews, goal setting, coaching, training, scheduling and other managerial responsibilities.

* Develops positive engagement with others

* Works autonomously to deliver on KPI and objectives agreed upon with Sr. VP, BioA Services

* Leads development improvements in quality processes and operational processes through continual process improvement initiatives

* Assesses current quality assurance standards, existing company quality policies and procedures to evaluate the effectiveness of the quality assurance program in order to determine areas of improvement to ensure compliance with regulatory requirements.

* Works with operations and scientific staff to provide quality and regulatory guidance for clients projects to enhance client satisfaction.

* Leads all client audits and regulatory agency inspections as well as formal responses to their findings/recommendations.

* Provides training to site employees in FDA Inspection Readiness activities and regulatory guidelines (i.e. preparation and conduct during regulatory inspections).

* Develops quality staff to support employee development and satisfaction.

* Oversees organizational facilities management that a system of archiving facilities documents and project study files is in place and is secure as expected by pertinent regulatory requirements.

* Develops and oversees training programs and training effectiveness, to ensure employees work to quality systems required in the areas of G_x_Ps and any other applicable regulations.

* Provides quality and regulatory guidance to site personnel, directly and via the Quality Assurance Unit (QAU), on quality related issues.

* Assures method validation protocols, validation reports, test methods, general laboratory protocols and standard operating procedures are reviewed by the QAU to assure regulatory compliance.

* Identifies areas of quality weakness and develops process improvements to ensure quality results.

* Develops the quality assurance program to define areas of responsibility, personnel requirements, and operational procedures within the quality program.

* Collaborates with other managerial personnel in formulating, establishing, and maintaining the company quality policies and standard operating procedures.

* Engages, directly and/or via the QAU, in site investigations in order to mitigate any quality-related issues and in identification of new quality improvements.

* Represents the company in regulatory and quality in external regulatory agencies and conferences.

* Acts as secondary back-up to archivist (and back-up archivist), as needed

* Acts as back-up/additional resource for quality assurance review of validations, reports, assays, deviations, etc.

* Reviews pertinent publications to stay abreast of the regulatory and quality developments within the industry
  • 1
  • Negotiable
  • None
  • None
  • Re-195584
  • Permanent
  • 5

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