Ash Spec Ireland Ltd
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.
Overview
We have 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).
Responsibilities
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.
Qualifications
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.
Benefits
We offer a competitive salary and benefits, pay‑for‑performance incentive plans and a diverse work environment where employees feel challenged and valued.
Equal Opportunity Statement
Ashland is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, or protected veteran status and will not be discriminated against on the basis of disability. NOTE: We do not accept resumes from external staffing agencies or independent recruiters for any of our openings unless we have a signed recruiting agreement in place to fill a specific position.
#J-18808-Ljbffr