Quality Manager

3 weeks ago

Dublin, Dublin City, Ireland Bausch & Lomb GmbH Full time
Quality Manager / QP / Responsible Person

Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people worldwide—from birth through all life stages. Our mission: helping you see better, to live better.

Our portfolio of over 400 products is fully integrated, serving customers across the entire spectrum of eye health needs. With a 170-year history, our trusted brand is supported by a global footprint of approximately 13,000 employees in around 100 countries, reaching billions of potential customers. We have contributed significantly to advancements in eye health and aim to continue leading in this field.

This position is based in Dublin, adopting a hybrid work model.

The Quality Assurance Manager, QP/RP at Bausch + Lomb Ireland Limited, is responsible for managing and maintaining the Quality Management System (QMS). The role also involves acting as the qualified person (QP) under EU GMP and the responsible person (RP) under EU GDP requirements.

KEY RESPONSIBILITIES:
  • Manage and ensure the effectiveness of the QMS, including approving SOPs and quality documents.
  • Maintain quality processes supporting BLIL authorizations (WDA, MIA, ASR).
  • Support BLIL as a Marketing Authorization Holder (MAH).
  • Communicate with and represent BLIL to authorities like the HPRA.
  • Provide QA expertise and manage quality issues to resolution.
  • Support and prepare for HPRA inspections, including drafting responses.
  • Support internal compliance audits and prepare HPRA variations.
  • Oversee QA for new product introductions.
  • Review and approve non-conformances, CAPA, change controls, and complaints.
  • Verify supplier and customer compliance with Good Distribution Practice.
  • Review batch records for GMP and market authorization compliance before release.
  • Manage technical agreements with licensees and third-party contractors.
  • Present and review quality performance at operational meetings.
  • Conduct internal audits and review QMS and operational procedures for compliance.
  • Organize and participate in management review meetings, preparing agendas and minutes.
  • Implement and oversee internal quality audits.
  • Investigate non-conformances, report findings, and implement CAPAs for continuous improvement.
  • Escalate issues as needed.

The QP must be eligible to act as a European Qualified Person, certifying products in accordance with relevant EU directives. The RP must be eligible to act as the EU GDP responsible person per EU GDP guidelines.

PERSON SPECIFICATION:
  • BSc (Hons) in Science or equivalent qualification.
  • Thorough knowledge of GMDPs and regulatory expectations for medicinal products and medical devices.
  • Minimum of 5 years' experience in Quality Assurance within the healthcare industry.
  • Ability to work independently and in teams.
  • Strong analytical, problem-solving, communication, and organizational skills.
  • Proven ability to deliver results, with interpersonal and influencing skills.
  • Ability to build internal and external relationships.
  • Trained auditor certification.
  • Willingness to travel if required.

Bausch & Lomb is committed to equal employment opportunity and complies with applicable laws.

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