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Senior Quality Assurance Leader

3 weeks ago


Ireland beBeeQuality Full time

**Job Description:**

We are seeking an experienced Senior Quality Assurance Leader to oversee the development, implementation, and maintenance of quality management systems across our engineering services and pharmaceutical QA operations.

The successful candidate will lead and manage a team of professionals, including hiring, training, performance evaluation, and professional development. They will be responsible for ensuring compliance with ISO standards, pharma QA regulations, and CQV/CxA best practices.

Key Responsibilities:

  • Develop and implement comprehensive CQV programs and procedures for pharmaceutical manufacturing and data center construction.
  • Ensure compliance with FDA regulations (cGMP), ISO standards (ISO 9001, ISO 27001), GAMP 5, and other relevant industry standards and regulations.
  • Lead audits to assess compliance with quality systems and regulatory requirements, focusing on CQV processes.
  • Manage document control, including creation, review, approval, and revision of SOPs, protocols, reports, and CQV documentation.

**Required Skills and Qualifications:**

  • Bachelor's degree in Engineering or related field.
  • Minimum 10 years of experience in Quality Assurance, with at least 5 years in a leadership role focused on CQV.
  • Extensive experience in the pharmaceutical industry, including knowledge of cGMP, FDA regulations, and validation processes.
  • Certifications such as ASQ Certified Quality Auditor (CQA) or Certified Quality Manager (CQM) are a plus.

**Benefits:**

  • Opportunity to work with a dynamic team and contribute to the success of the organization.
  • Chance to develop and implement quality management systems that meet regulatory requirements.
  • Professional growth and development opportunities.

**Others:**

  • Strong communication, interpersonal, and relationship-building skills.
  • Ability to engage and influence at all levels of the organization.
  • A passion for Quality Engineering practices and proven record of implementing such practices.
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