Quality Manager

7 days ago

Dublin, Dublin City, Ireland Bausch + Lomb Ireland Full time

Join to apply for the Quality Manager role at Bausch + Lomb Ireland.

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 around the world from the moment of birth through every phase of life. Our mission is simple, yet powerful: helping you see better, to live better.

Our comprehensive portfolio of over 400 products is fully integrated and built to serve our customers across the full spectrum of their eye health needs throughout their lives. Our iconic brand is built on the deep trust and loyalty of our customers established over our 170-year history. We have a significant global research, development, manufacturing and commercial footprint of approximately 13,000 employees and a presence in approximately 100 countries, extending our reach to billions of potential customers across the globe.

This position is based in Dublin, Citywest working on a hybrid model, 3 days on site and 2 days from home.

The Quality Assurance Manager, QP/RP at Bausch + Lomb Ireland Limited has responsibility for the management and maintenance of the BLIL Quality Management System. Furthermore, the job holder is acting as qualified person as per EU GMP and responsible person as per EU GDP requirements.

Key Responsibilities

  • Manage the QMS, ensure the QMS is fit for purpose, making changes as necessary approving SOPs and Quality System documents.
  • Maintain Quality processes in support of BLIL authorizations (WDA, MIA, ASR).
  • Ensure processes are maintained in support of BLIL as MAH.
  • Manage communications with and represent BLIL in front of HPRA.
  • Provide QA expertise to BLIL and manage any Quality issues that arise to closure.
  • Support HPRA inspections of BLIL and prepare written responses to inspections.
  • Support Bausch + Lomb internal compliance audits of the BLIL operations.
  • Prepare and approve HPRA variations.
  • Provide QA oversight and expertise for New Product Introductions.
  • Review and approve Non-Conformances (NC), CAPA, change controls and complaints.
  • Ensure annual review of supplier and customer bona fides to verify compliance with Guidelines on Good Distribution Practice.
  • Ensure Batch record review to verify compliance with GMP and Market Authorization prior to batch release.
  • Review, and where appropriate, preparation and regular update of technical agreements with licensees and 3rd party contractors.
  • Regular presentation and review of intercompany Quality service provider performance against measures relating to the BLIL Quality Objectives at periodically held Quality Operations meetings.
  • Periodic review of QMS and operational procedures for regulatory compliance through internal audit system.
  • Scheduling periodic Quality Operations management review meetings with third parties, annual Quality Management Review meetings, and preparing the agenda and minutes for both meetings.
  • Attending the annual Quality Management Review meeting and participating in the review of the BLIL Quality and Regulatory Compliance Policy and Objectives for continuing suitability.
  • Implementation of the Self Inspection/Internal Quality Audit program.
  • Overall responsibility for reporting and investigation of non-conformances and identification of CAPAs to ensure continuous improvement of the QMS and operational procedures.
  • Escalation of issues as appropriate.

The QP must be eligible to act as a European Qualified Person (QP), certifying products in compliance with 2001/83/EC, 2003/94/EC and Annex 16.

The RP must be eligible to act as EU GDP responsible person as per EU GDP guideline.

PERSON SPECIFICATION

  • BSc (Hons) in Science or equivalent.
  • QP/RP qualification.
  • Thorough working knowledge of GMDPs and regulatory expectations for medicinal products and medical devices.
  • Minimum of 5 years of experience working in Quality Assurance in the Health Care Industry.
  • Ability to work on their own initiative and within teams.
  • Be able to analyse complex problems and identify solutions.
  • Strong communication and organizational skills.
  • Leadership skills.
  • Excellent ability to deliver results, with strong interpersonal and influencing skills.
  • Ability to build relationships internally and externally.
  • Trained auditor.
  • Available to travel if required to fulfil role.
Benefits
Work From Home
Seniority level
  • Mid-Senior level
Employment type
  • Full-time
Job function
  • Quality Assurance
Industries
  • Manufacturing
#J-18808-Ljbffr

  • Healthcare Quality Management Professional

    2 days ago

    Dublin, Dublin City, Ireland MEG | Healthcare Quality Management Software Full time

    Company OverviewAt MEG | Healthcare Quality Management Software, our mission is to provide innovative technology solutions for healthcare teams that improve care quality standards and patient safety. With a relentless focus on creating a better experience for the working lives of frontline staff, our team is united around building software that enables...

  • Restaurant Performance Improvement Manager

    7 days ago

    Dublin, Dublin City, Ireland In - Manager Recruitment Full time

    Job Title: General Management LeadJob Description:We are seeking an experienced General Management Lead to join our team at In - Manager Recruitment. As a key member of our senior leadership team, you will be responsible for driving sales growth, improving operational efficiency, and enhancing customer experience.Main Responsibilities:- Develop and implement...

  • Strategic Operations Manager

    11 hours ago

    Dublin, Dublin City, Ireland In - Manager Recruitment Full time

    About KFCKFC is a global fast-food chain with a rich history dating back to 1952. Our commitment to quality and customer satisfaction has earned us a loyal following around the world.Job SummaryWe are seeking an experienced Restaurant Leader to join our team at KFC. As a key member of our management team, you will be responsible for driving restaurant...

  • High-Performance Restaurant Manager

    12 hours ago

    Dublin, Dublin City, Ireland In - Manager Recruitment Full time

    About KFCKFC is a renowned global fast-food chain with a reputation for delivering high-quality food and exceptional customer service.Job DescriptionWe are seeking an experienced Restaurant Executive to join our team at KFC. As a key member of our management team, you will be responsible for driving restaurant performance and achieving business...

  • Performance Driven General Manager

    3 days ago

    Dublin, Dublin City, Ireland In - Manager Recruitment Full time

    About KFCKFC is a global fast-food chain with a rich history dating back to 1952. Our commitment to quality and customer satisfaction has earned us a loyal following around the world.Job SummaryWe're seeking a Performance Driven General Manager to join our team at KFC. As a key member of our management team, you will be responsible for driving restaurant...

  • Performance Driven General Manager

    15 hours ago

    Dublin, Dublin City, Ireland In - Manager Recruitment Full time

    About KFCKFC is a global fast-food chain with a rich history dating back to 1952. Our commitment to quality and customer satisfaction has earned us a loyal following around the world.Job SummaryWe're seeking a Performance Driven General Manager to join our team at KFC. As a key member of our management team, you will be responsible for driving restaurant...

  • Transportation Operations Manager

    6 days ago

    Dublin, Dublin City, Ireland Quality Freight Group Full time

    Why Quality Freight Group?We offer comprehensive freight solutions, from basic container transport to complex international transits using various modes of transport.Our dedicated team is committed to adding value for our customers, providing reliable and efficient services at every level.

  • Experienced Restaurant Leader

    12 hours ago

    Dublin, Dublin City, Ireland In - Manager Recruitment Full time

    About KFCKFC is a leading global fast-food chain with a long history of delivering quality food and exceptional customer service.Job OverviewWe are seeking a highly skilled Restaurant Manager to join our team at KFC. This role offers a unique opportunity to lead a high-performance team and drive business growth.Key Responsibilities:Restaurant Leadership:...

  • Restaurant Performance Director

    11 hours ago

    Dublin, Dublin City, Ireland In - Manager Recruitment Full time

    About KFCKFC is a global leader in the fast-food industry with a strong brand reputation and a commitment to quality and customer satisfaction.Job OpportunityWe are seeking a highly motivated Restaurant General Manager to join our team at KFC. This role offers a unique opportunity to lead a high-performance team and drive business growth.Key...

  • Quality Manager

    4 weeks ago

    Dublin, Dublin City, Ireland Cpl Full time

    Quality Manager  Building Envelop Systems Perm, Remote, Salary negotiable depending on experience. Our client, Irelands leading specialist roofing, cladding and façade contractor is looking to hire a Quality Manager to join the team. Role Summary: The Quality Manager is responsible to oversee quality assurance for the installation of building...

  • Quality Manager

    1 day ago

    Dublin, Dublin City, Ireland Next Generation Recruitment Full time

    Title: Quality ManagerLocation: CarlowIndustry: ConstructionOverview:A leading designer and manufacturer of modular infrastructure is seeking a Quality Manager to oversee and maintain quality management systems in line with ISO 9001 and EN 1090 standards. This role involves ensuring compliance, driving continuous improvement, and liaising with customers to...

  • Quality Manager

    2 days ago

    Dublin, Dublin City, Ireland Poutrix Full time

    Arcadis is the world's leading company delivering sustainable design, engineering, and consultancy solutions for natural and built assets.We are more than 36,000 people, in over 70 countries, dedicated to improving quality of life.Everyone has an important role to play.With the power of many curious minds, together we can solve the world's most complex...

  • Quality Manager

    4 days ago

    Dublin, Dublin City, Ireland Design Build Search Full time

    Quality Manager - Dublin Are you a dedicated Quality Manager ready to take the next step in your career? Our client, a prominent Commercial Construction contractor is seeking a skilled Quality Manager to work on a project in Dublin. An onsite project role it offers the chance to lead quality initiatives across diverse commercial, and industrial projects,...

  • Quality Manager

    2 weeks ago

    Dublin, Dublin City, Ireland Poutrix Full time

    Arcadis is the world's leading company delivering sustainable design, engineering, and consultancy solutions for natural and built assets.We are more than 36,000 people, in over 70 countries, dedicated to improving quality of life. Everyone has an important role to play. With the power of many curious minds, together we can solve the world's most complex...

  • Quality Manager

    4 days ago

    Dublin, Dublin City, Ireland O'Kane Resourcing Full time

    Quality Manager (SHEQ) Manufacturing / Engineering Role Overview: We are seeking a proactive and dynamic Quality Manager to oversee and enhance the Integrated Management System (IMS), ensuring compliance with ISO standards and driving continuous improvement.In this role, you will collaborate across departments to manage safety and quality issues, implement...

  • Quality Manager

    3 weeks ago

    Dublin, Dublin City, Ireland SCOPE OPHTHALMICS LTD Full time

    We are currently recruiting for a Quality Manager to join our Quality and Regulatory Affairs team This is a remote role and can be based in either the UK or Ireland.This role will lead and maintain our Global Quality Management System (QMS) across a diverse product portfolio that includes medicines, medical devices, dietary supplements, cosmetics, and US...

  • Quality Manager

    3 weeks ago

    Dublin, Dublin City, Ireland Smurfit Westrock plc Full time

    Join to apply for the Quality Manager role at WestRock Company.Job Title: Quality ManagerReports to: Regional Quality ManagerJob PurposeThe role focuses on compliance, customers, and continuous improvement activities to create a total quality culture and reduce quality costs in line with best practice procedures.• To protect and please the customer by...

  • Quality Manager

    23 hours ago

    Dublin, Dublin City, Ireland Seda Talent Full time

    Quality ManagerOur client is an innovative and progressive global company and is sourcing for a Quality Manager to join their team in Greater Dublin. This organisation has a manufacturing presence in over 40 countries around the world, with over 30 million people reliant on their products that serve to improve their lives.The Quality Manager role is open to...

  • Quality Manager

    4 days ago

    Dublin, Dublin City, Ireland Force Recruitment Full time

    ***Candidate needs to be based in Ireland to apply***Force have partnered with the leading global eye healthcare company who are on a lookout for a Quality Manager /QP . The Quality Manager has responsibility for the management and maintenance of BLIL Quality Management System. Furthermore, the job holder is acting as qualified person as per EU GMP and...

  • Quality Manager

    5 days ago

    Dublin, Dublin City, Ireland TN Ireland Full time

    NEW ROLE: Quality Manager required for plastics contract manufacturing facility in Wicklow. This is a customer-facing role working with medical device clients in the US, responsible for audits, managing QMS, and customer complaints. Knowledge of ISO and cGMP is essential.Responsibilities:Manage and develop quality assurance systems as an adjunct to...