Quality Manager Role
We are seeking a highly experienced Quality Manager to join our team at {company}.
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 of 4 individuals and be responsible for ensuring the quality management system (QMS) is effectively implemented and maintained.
About Our Company
We are a rapidly growing company that is a recognized leader in developing and manufacturing biopolymers for the medical device and pharmaceutical industries.
Since entering the Irish market just a few years ago, we have completed the fit out of a state-of-the-art lab and manufacturing plant and have further plans for future expansion.
Key Responsibilities:
* Represent the company during audits and site visits.
* Ensure the 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.
Job Requirements
Education: Bachelors degree (Level 8 or higher) in science, technology, engineering, or manufacturing. Masters 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.
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.
Benefits
Our ideal candidate will have a strong background in quality management and leadership, excellent communication skills, and the ability to work effectively in a fast-paced environment.