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INNOTEQ INC

Document ID: A8062-2M2L Posted on: 02/12/2014 Job Type: Regular

Job Schedule:Full-time
 

Quality Assurance Manager

Quality Assurance Manager

Description:

The primary responsibility of the QA Manager is to oversee the development, implementation and management of Quality Assurance programs and initiatives for GMP activities, and to conduct internal and external audits to assess compliance with GMP regulations.  This position reports to the Associate Director, Quality.

Responsibilities:

  • Works with Senior Management and other Quality staff to oversee the development and implementation of an FDA compliant Quality System for GMP activities.
  • Provides periodic updates to Senior Management regarding the Quality System.
  • Provides expert cGMP compliance and general QA support; acts as liaison between product development teams and QA.
  • Plans, coordinates and conducts internal and external (domestic and international) GMP-related audits, including  vendor audits (contract laboratories and raw material vendors).
  • Assists in the development and maintenance of quality management systems from the GMP perspective.
  • Creates, revises, reviews, and approves quality-related documents, including procedures, memoranda, protocols, and reports.
  • Reviews SOPs to ensure compliance with applicable regulatory and corporate standards.
  • Participates in the development and delivery of internal training programs.
  • Oversees the preparation for regulatory agency inspections.
  • Supports the preparation, coordination, and management of regulatory agency inspections.  During inspection, plays a lead role as facilitator and communicator.
  • Keeps up to date with current regulatory guidelines and regulations.
     

Requirements:

  • Bachelors Degree in a scientific discipline with a minimum of 8 years’ previous experience in a pharmaceutical quality assurance/compliance/GMP auditing role. 
  • At least 3 of these years must have been in a QA Manager role. 
  • Must understand business processes/project management and have previous knowledge of regulatory environment impact and pharmaceutical development programs (GMP’s, NDA submission, ICH, etc.). 
  • Must be familiar with ISO 9001.
  • Bilingual proficiency  (Spanish) is preferred.
 
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