Director, Compliance Quality Assurance

Job Locations US-MA-Bedford
Posted Date 3 weeks ago(1/31/2018 1:43 PM)
Job ID
2018-1050
# of Openings
1
Category
Quality

Overview

This position is responsible for the development, implementation, and maintenance of the supplier qualification and the audit program to ensure compliance with internal procedures, and applicable regulations and guidance document.  Responsibilities include overseeing compliance related initiatives, such as the internal auditing program, as well as external audits, approved supplier list, quality agreements, annual product reviews, and management reviews.  Additional responsibilities include supporting the development of GMP training matrices, delivering GMP training, SOP development and/or revisions, and other duties as assigned.    

Responsibilities

  • Develop and implement supplier management program. Establish and maintain an approved supplier list.
  • Develop and implement internal and external audit program. In that, establish an annual schedule for internal and external audits.  Ensure audit schedule is executed as planned.  Write audit reports within 30 days from the audit date.  Follow-up on audit observations until adequate closure.
  • Support external audits (regulatory bodies and client audits) on an as need basis. Responsibilities may include Hosting external audit and/or coordinating the war room activities.
  • Develop and implement material qualification program.
  • Management of Quality agreements, Management reviews and Annual Product reviews as required.
  • Provide compliance support during regulatory inspections of the company, or potential partners as applicable.
  • Stay abreast of changes in FDA and European regulations, directive and guidelines and determine its impact on company studies.
  • Develop and implement SOPs relating to the audit program.
  • Perform trending and analysis as required and provide metrics to quality management as requested.
  • Complete other duties and tasks as required.
  • 10%-20% Travel
  • Computer literate with a strong proficiency in Microsoft Office.
  • Ability to work productively with personnel from various departments

Qualifications

  • Bachelor’s degree in life sciences or related field required
  • 10+ years of experience in the pharmaceutical industry, experience specific to Quality Assurance or Manufacturing fields strongly preferred, 5+ years of experience in conducting internal and external audits
  • Working knowledge of quality assurance, quality systems, and auditing
  • Knowledge of regulations and standards affecting Pharmaceuticals
  • Experience with GMP/GCP/ICH standards and regulatory guidance documents
  • Experience in auditing and writing formal audit reports
  • Excellent verbal and written communication skills
  • Certified Quality Auditor (CQA) certification preferred

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