Quality Assurance Manager
Lead a quality team of four, including a QA/QC Tech Lead, two QC Lab Technicians, and a Quality Specialist, in a leading life sciences company in Mullingar, Ireland.
About the Company
The company specializes in the development and manufacturing of biopolymers for medical devices and pharmaceutical products. Their Mullingar facility is a hub for producing these innovative solutions.
Key Responsibilities
* Represent the company during audits and site visits.
* Ensure the Quality Management System (QMS) is effectively implemented and compliant with ISO 13485, ISO 9001, and EXCiPACT standards.
* Promote awareness of regulatory and customer requirements throughout the organization.
* Supervise and mentor a quality team to deliver on key initiatives and compliance goals.
* Oversee documentation, training, and strategies to uphold quality standards.
* Lead quality improvement projects and ensure timely task completion.
* Guide product development processes, from concept to commercialization.
* Prepare for and represent the company during regulatory audits and inspections.
* Manage Corrective and Preventive Actions (CAPAs) and Non-Conformance Reports (NCRs).
* Foster collaboration and effective communication across departments.
Job Requirements
* Education: Bachelor's degree (Level 8 or higher) in science, technology, engineering, or manufacturing.
* A master's degree or PhD is advantageous but not required.
* Experience & Knowledge:
o 7+ years of experience in the pharmaceutical or a similar regulated industry, including leadership roles.
o Strong understanding of pharmaceutical/chemical manufacturing processes is a plus.
o Expertise in QMS management and regulatory compliance (e.g., ISO 13485, ISO 9001).
o Experience managing CAPAs, NCRs, change management, and customer complaints.
o Familiarity with medical device regulations, process validation, and equipment qualification.
o Proficiency in Six Sigma and Lean methodologies.
* Skills:
o Advanced problem-solving and decision-making abilities.
o Strong leadership and project management experience.
o Certified auditor qualifications (e.g., IRCA Lead Auditor) are a plus.
o Proven ability to contribute to cross-functional product development teams.