QA Specialist – Supplier Quality Management

Basic Role Summary:

To ensure that all suppliers, contract manufacturers (CMOs), and other external partners involved in manufacturing, testing, or distribution of products comply with regulatory requirements and company quality standards. The QA Specialist manages supplier quality programs, oversees external audits, and supports quality agreements and risk management activities.

Location: Onsite at our facility in Loughrea.

As our QA Specialist, your key responsibilities will be as follows:

• Supplier Quality Management

  • Maintain and manage the approved supplier list and ensure compliance with qualification requirements.

  • Conduct supplier evaluations and risk assessments to ensure adherence to GMP and regulatory standards.

  • Monitor supplier performance through metrics, audits, and periodic reviews.

• External Party Oversight

  • Act as the primary QA contact for third-party manufacturers, CMOs, and testing laboratories.

  • Ensure quality agreements are in place, maintained, and aligned with regulatory expectations.

  • Coordinate quality-related communications and issue resolution with external partners.

• Audit & Inspection Management

  • Plan, schedule, and conduct supplier and third-party audits, including documentation and reporting.

  • Track and ensure timely closure of audit findings and CAPAs.

  • Support regulatory inspections involving external manufacturing or testing partners.

• Compliance & Documentation

  • Ensure compliance with Marketing Authorizations and regulatory requirements for outsourced activities.

  • Maintain accurate records of supplier qualifications, audits, and quality agreements.

• Continuous Improvement

  • Identify opportunities to improve supplier quality processes and implement best practices.

  • Stay updated on regulatory changes impacting supplier and external quality management.

Qualifications and Experience:

• Degree in Quality Assurance, Pharmaceutical Science, Life Sciences, or related discipline.

• 3–5 years in a QA role within a GMP-regulated environment.

• Experience in supplier quality management and external party oversight.

Skills and Competencies:

• Compliance Mindset: Commitment to maintaining high standards of regulatory compliance.

• Attention to Detail: Ensures accuracy and completeness in documentation and audits.

• Risk-Based Thinking: Ability to assess and mitigate supplier-related risks.

• Collaboration: Works effectively with internal teams and external partners.

• Problem-Solving: Ability to resolve quality issues promptly and effectively.

• Strong knowledge of GMP and regulatory requirements for outsourced activities.

• Excellent organizational and documentation skills.

• Ability to manage relationships and communicate effectively with external partners.

  
  

Applicants from diverse backgrounds, including those returning after a career break or with transferable skills from non-traditional career paths, are encouraged to apply. We value varied experiences and are committed to fostering an inclusive environment that supports individuals with disabilities.