Job Title: Quality/Regulatory Compliance Manager Location: Ballina, Co. Mayo, Ireland Employment Type: Permanent, Full-Time €70,000 - €80,000 About the Role: We have an exciting opportunity within our clients Biologics Division for a Quality/Regulatory Compliance Manager.
You will lead a team of 12 direct reports and oversee the GMP Quality Assurance program to ensure compliance with regulatory requirements, minimising business interruptions.
This role involves working closely with the site management team to implement and improve the Compliance Program, ensuring consistency with company policies and procedures.
Responsibilities: * Develop departmental policies and procedures to meet regulatory requirements.
* Manage and mentor a team to fulfil Quality Assurance responsibilities.
* Provide regulatory training and support for Quality Assurance and operations staff.
* Schedule and manage resources to ensure timely completion of audits, inspections, investigations, and review/approval of SOPs and Change Controls.
* Review and endorse Quality Assurance reports to ensure proper interpretation of regulatory requirements.
* Prepare and retain records and reports in compliance with regulatory standards.
* Consult with operations personnel on audit findings, corrective actions, and preventative measures.
* Interface with Regulatory Agencies during inspections.
* Administer compliance and quality programs, providing periodic reports to management.
* Represent the company during regulatory and client inspections/audits.
* Prepare site personnel for client and regulatory audits, and manage audit responses and corrective actions.
* Ensure vendor and supplier compliance with regulatory requirements.
* Participate in Regulatory Affairs and Compliance projects and programs.
* Perform general auditing duties and prepare written reports on audit activities.
* Communicate compliance and quality risks to supervisors.
* Assist with Vendor Assessment, client audits, and subcontractor audits.
* Implement Corporate Quality and Compliance Policies at the site.
Requirements: * BSc.
in a relevant Science discipline.
* Extensive experience in GMP standards within Quality Assurance.
* Strong leadership and people management skills.
* Experience managing teams of 10+ direct reports.
* Previous experience in Quality Control/Analytical functions is desirable.
* Proven track record in hosting client and regulatory inspections (HPRA, FDA).
* Excellent attention to detail and accuracy.
* Strong knowledge of pertinent regulations.
* Exceptional leadership, communication, and facilitation skills.
* Excellent written and verbal communication skills.
* Proficiency in MS Word, Excel, PowerPoint.
Apply Now: If you are a dedicated Quality Assurance and Compliance professional looking to take the next step in your career and join a global organisation committed to improving patient lives, we encourage you to apply
