Quality Manager
at STEM Recruitment Partners
County Westmeath, County Westmeath, Ireland -
Start Date | Expiry Date | Salary | Posted On | Experience | Skills | Telecommute | Sponsor Visa |
---|---|---|---|---|---|---|---|
Immediate | 25 Apr, 2025 | USD 75000 Annual | 25 Jan, 2025 | 7 year(s) or above | Process Validation,Capas,Equipment Qualification,Regulatory Compliance,Six Sigma,Manufacturing,Technology | No | No |
Required Visa Status:
Citizen | GC |
US Citizen | Student Visa |
H1B | CPT |
OPT | H4 Spouse of H1B |
GC Green Card |
Employment Type:
Full Time | Part Time |
Permanent | Independent - 1099 |
Contract – W2 | C2H Independent |
C2H W2 | Contract – Corp 2 Corp |
Contract to Hire – Corp 2 Corp |
Description:
STEM Recruitment Partners is working with a leading life sciences company in Westmeath to recruit a Quality Manager for their dynamic team. This is a high-impact, permanent role within the organization’s Quality function, reporting directly to the Global Quality Director.
You will lead a team and manage a team of 4 individuals, that consists of 1 QC/QA Tech lead, 2 QC Lab Technicians and 1 Quality Specialist.
JOB REQUIREMENTSEDUCATION
- Bachelor’s degree (Level 8 or higher) in science, technology, engineering, or manufacturing.
- Master’s or PhD is beneficial but not required.
EXPERIENCE & KNOWLEDGE
- 7+ years of experience in the pharmaceutical or similar industry, including leadership roles.
- Strong knowledge of pharmaceutical/chemical manufacturing is advantageous.
- Expertise in QMS management and regulatory compliance (e.g., ISO 13485, ISO 9001).
- Hands-on experience with CAPAs, NCRs, change management, and customer complaints.
- Familiarity with medical device regulations, process validation, and equipment qualification.
- Proficiency in Six Sigma and Lean methodologies.
SKILLS
- Advanced problem-solving and decision-making abilities.
- Proven leadership and project management experience.
- Certified auditor qualifications (e.g., IRCA Lead Auditor) are a plus.
- Strong track record in cross-functional product development teams.
Job Type: Full-time
Pay: €75,000.00-€85,000.00 per year
Work Location: In perso
Responsibilities:
- Represent the company during audits and site visits.
- Ensure the quality management system (QMS) is effectively implemented and maintained.
- Report on QMS performance and recommend improvements to top management.
- Drive regulatory and customer requirements awareness across the organization.
- Lead and supervise Quality Assurance Specialists and Quality Control Technicians.
- Oversee the QMS and ensure compliance with standards like ISO 13485, ISO 9001, and EXCiPACT.
- Manage documentation, training, and compliance strategies.
- Direct sub-teams to achieve quality improvements and complete assigned tasks.
- Guide the design and commercialization of innovative products.
- Manage projects by delegating tasks and making key decisions.
- Represent the company during audits and inspections.
- Develop technical documentation aligned with regulatory standards.
- Conduct management reviews in the capacity of a quality representative.
- Manage Corrective and Preventive Actions (CAPAs) and Non-Conformance Reports (NCRs).
- Lead audit preparations and regulatory requirement adherence.
- Foster collaboration and positive communication across teams.
REQUIREMENT SUMMARY
Min:7.0Max:12.0 year(s)
Pharmaceuticals
Production / Maintenance / Quality
Clinical Pharmacy
Graduate
Science technology engineering or manufacturing
Proficient
1
County Westmeath, Ireland