Biostór Ireland is seeking an experienced Quality/Regulatory specialist to join our dynamic team at the Rosslare bioresource facility. The successful candidate will be responsible for overseeing all aspects of the company's quality and safety policy, ensuring the highest standards of compliance in collaboration with the Operations and Regulatory teams.
Key Responsibilities:
1. Quality Management System (eQMS): Develop, implement, and maintain a robust electronic Quality Management System in compliance with regulatory requirements, industry standards, and company policies.
2. Regulatory Compliance: Oversee and ensure compliance with relevant regulatory guidelines, including Irish Quality and Safety of Human Tissues and Cells Regulations, FDA, EMA, and other global regulatory authorities.
3. Team Collaboration: Fostering a culture of continuous improvement by working closely with Operations to uphold and enhance quality standards through regular audits and assessments of processes, facilities, and systems to ensure compliance with Good Manufacturing Practices (GMP).
4. Problem Solving and Productivity Improvement: Support initiatives related to problem-solving, cost savings, and drive continuous improvement initiatives to enhance efficiency, reduce deviations, and optimize processes.
5. Liaison: Serve as the quality representative in interactions with outside regulatory agencies, customers, and third-party auditors, ensuring adherence to all regulatory requirements.
6. Leadership Support: Provide vision and direction to the leadership team, contributing to strategic decision-making and guiding the company in maintaining high-quality standards.
7. Risk Management: Implement risk management strategies and practices to identify, assess, and mitigate quality and compliance risks to product services.
8. Training and Development: Provide direction and guidance for the training and development, fostering a culture of quality awareness and continuous learning.
9. Validation: Qualify, verify quality processes by establishing specifications and quality attributes.
Qualifications & Core competencies:
1. Bachelor's degree in a relevant scientific or engineering discipline (Life Sciences, Regulatory, Quality Management, etc.).
2. Proven experience in a quality management role within a regulated environment, preferably in the life sciences or pharmaceutical industry.
3. Familiarity with HPRA regulations and strong knowledge of GMP, regulatory guidelines, industry best practices other relevant quality standards.
4. Excellent leadership and communication skills.
5. Problem-solving mindset and the ability to drive continuous improvement initiatives.
How to Apply: Interested candidates should submit their resume and cover letter to and by 12th January 2026.
Please include "Quality & Regulatory Application - Biostór Ireland" in the email subject line.
Biostór Ireland is an equal opportunity employer committed to diversity and inclusion in the workplace. We are committed to a strong work-life balance and offer a hybrid working environment. We encourage individuals from all backgrounds to apply.
Application Deadline: 12th Jan 2025
Job Type: Full-time
Pay: €35,000.00-€40,000.00 per year
Benefits:
* Bike to work scheme
* Company pension
* Flexitime
* On-site parking
* Work from home
Ability to commute/relocate:
* Kilrane, County Wexford: reliably commute or plan to relocate before starting work (preferred)
Work authorisation:
* Ireland (required)
Work Location: Hybrid remote in Kilrane, County Wexford