Quality Manager

Matrix Recruitment Group

Mullingar

On-site

EUR 70,000 - 110,000

Full time

4 days ago
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Job summary

Ashland in Mullingar, Ireland, is seeking a Quality Manager to lead QA and QC teams and own the site Quality Management System. This role reports to the Quality Director (Global) and drives GMP compliance, regulatory alignment, and continuous improvement across analytical QC activities.

The successful candidate will oversee laboratory operations, support product lifecycle activities, and lead audits with strong problem-solving and risk-based decision making.

Qualifications

  • Level 8+ qualification in Science (Chemistry or related).
  • 3+ years’ experience in a GMP-regulated manufacturing environment with people leadership.
  • Strong knowledge of QMS and regulatory compliance (ISO 13485, IPEC GMP, ISO 14971 or equivalent).
  • Experience managing deviations, CAPAs, change control, audits, supplier quality and complaints.
  • Working knowledge of analytical QC techniques (e.g., GC, ICP-MS, Karl Fischer, potentiometric titration, GPC/SEC, polarimetry).
  • Understanding of equipment qualification, process validation and cross-functional project delivery.
  • Strong problem-solving, ethical judgment and risk-based decision making.

Responsibilities

  • Provide leadership and oversight of QA and QC teams including coaching and development.
  • Maintain and improve the site Quality Management System (QMS) and ensure GMP compliance.
  • Act as site Quality Management Representative during regulatory and customer audits.
  • Lead quality activities across product lifecycle including changes, validation and tech transfers.
  • Oversee laboratory readiness, instrument qualification, calibration and data integrity.
  • Engage with senior management to drive quality metrics and continuous improvement.

Skills

GMP knowledge
QA/QC leadership
Regulatory compliance
Deviation & CAPA management
Analytical QC techniques
Risk-based decisions
Cross-functional delivery

Education

Bachelors in Science
Postgraduate degree

Job description

Are you the kind of person that is always thinking, sketching, seeking, and adjusting? Who needs to understand how things work and then figure out how they can work better? Are you a passionate, tenacious, solver who loves to work with others who share your drive? Are you positive, constructive, and ingenious? Are you always solving? Then we’d like to meet you and bet you’d like to meet us.

Ashland has an exciting opportunity for a Quality Manager to join our Life Sciences business at our Mullingar, Ireland facility. This is a very visible, significant role within the Company and the Quality function. This position will report to Quality Director (Global).

The responsibilities of the position include, but are not limited to, the following:
  • Provide leadership and functional oversight of both Quality Assurance and Quality Control (analytical laboratory) teams, including:
    • Direct supervision, coaching, and development of QA Specialists and QC Technicians/Analysts
    • Ensuring appropriate resourcing, training, and capability within the Quality function
    • Maintaining a strong Quality culture with clear accountability and GMP ownership
  • Act as the site Quality Management Representative, including:
    • Representing Ashland during regulatory inspections, certification audits, customer audits, and company visits
    • Ensuring processes required for the Quality Management System (QMS) are established, implemented, maintained, and continuously improved
    • Reporting on QMS performance, compliance status, risks, and improvement opportunities to senior and global management
    • Promoting awareness of regulatory, quality, and customer requirements across the organization
  • Maintain oversight of laboratory operations, including:
    • Technical experience and/or working knowledge of a range of analytical laboratory techniques, including but not limited to GC, ICP-MS, Karl Fischer, potentiometric titration, GPC (size-exclusion chromatography), and polarimetry, sufficient to provide effective oversight of QC laboratory activities, data review, and investigations.
    • Ensuring laboratory activities complies with approved methods, SOPs, GMP, and data integrity requirements
    • Oversight of laboratory readiness for inspections, including instrument qualification, calibration, and documentation practices
  • Own and maintain the site Quality Management System, including:
    • Implementation and maintenance of Quality systems, procedures, documentation, and training programs in line with ISO 13485, EXCiPACT, ICH Q7, and applicable GMP requirements
    • Management of deviations, non-conformances, CAPAs, change controls, complaints, and risk management activities
    • Preparation and approval of quality and regulatory documentation in accordance with internal procedures and external requirements
  • Lead Quality activities supporting product lifecycle and site initiatives, including:
    • Quality input into new product introductions, process changes, scale-up activities, validation, and technical transfers
    • Oversight of design verification/validation, test method development, shelf life activities, and product commercialization from a Quality perspective
  • Serve as lead Quality representative for audits and inspections, including:
    • Leading the site through regulatory and customer audits
    • Ensuring timely and effective audit responses and sustainable corrective actions.
In order to be qualified for this role, you must possess the following:
  • Level 8 (or higher) qualification in Science (Chemistry), or a related discipline; postgraduate degree advantageous
  • 3+ years’ experience in a GMP-regulated manufacturing environment with people leadership responsibility
  • Strong knowledge of QMS and regulatory compliance (ISO 13485, IPEC GMP, ISO 14971, or equivalent)
  • Proven experience managing deviations, CAPAs, change control, audits, supplier quality, and complaints
  • Working knowledge of key analytical QC techniques (e.g. IV, GC, ICP-MS, Karl Fischer, potentiometric titration, GPC/SEC, polarimetry) sufficient for laboratory oversight
  • Understanding of equipment qualification, process validation, and cross-functional project delivery
  • Strong problem-solving, ethical judgment, and ability to drive value through risk-based decisions
Additional information –

This is a strategically important role requiring strong Quality leadership experience within a regulated environment (ISO 13485, EXCiPACT, ICH Q7, or equivalent). The Quality Manager will lead both QA and QC teams, maintain and continuously improve the site Quality Management System, and act as lead Quality representative during audits and inspections. The role requires the ability to engage effectively with senior management, oversee analytical QC activities with a sound understanding of laboratory operations, and use quality metrics, audits, and continuous improvement tools to ensure ongoing compliance and performance.

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