Quality Compliance Specialist - 12 Month FTC

Grifols Shared Services North America, Inc; Dublin; On-site; EUR 60,000 - 90,000; Full time

Benefits offered by this job

Annual performance-based bonus

Share-options scheme

Group pension scheme with company-m06

Private medical insurance

Career development opportunities

Succession planning

Job summary

Grifols Shared Services North America, Inc. is seeking a Quality Compliance Specialist to execute compliance within the QMS across the site and maintain awareness of system performance. You will support regulatory requirements, Grifols policies, and QA audits.

The role involves reporting, data analysis, CAPA drive, and cross‑functional collaboration to ensure external audit readiness and continuous improvement.

Qualifications

• Bachelor's degree in a scientific field or equivalent.
• Two to four years’ experience in the pharmaceutical/biotech industry.
• Experience assisting or managing QA audits and inspections.
• Good working knowledge of pertinent regulations and site SOPs.
• Strong communication and facilitation skills.
• Certification in auditing preferred.

Responsibilities

• Provide reports on QMS metrics to site management.
• Manage quality system integration, data integrity, and training requirements.
• Support audits of suppliers/ Outsourced providers and external audits.
• Coordinate self-inspection program and ensure CAPA is implemented.
• Analyze quality data to improve product and process quality; share best practices.
• Communicate with cross‑functional teams on compliance issues.

Skills

Word

Excel

PowerPoint

Auditing

Quality systems

Data analysis

Communication skills

Education

Bachelor's degree (B.A./B.S.) or equivalent

MSc in science, pharmacy or related discipline

Job description

Position Summary

The Quality Compliance Specialist is responsible for the execution of a variety of compliance requirements within the Quality Management System (QMS) of the site. This role is key in maintaining and updating compliance activities throughout the site, while ensuring management’s awareness of the systems performance. The execution of all applicable requirements related to QMS, Corporate requirements, Regulatory compliance, and applicable Grifols Policies or Procedures.

What You'll Do

• Potential Responsibilities at management discretion: Provide reports to site in relation to Quality Management System (QMS) as required. Provide regular reports on site's metrics to appropriate management.
• Management and ownership of: Quality system integration; Data Integrity system; Applicable training requirements (GMP introductory and refresher training); Quality Risk Management; Supplier management system; Support the completion and execution of Site Quality Council and Annual Product Reports; Communicate with cross‑functional departments regarding compliance and quality systems issues; Support or conduct audits of suppliers/outsourced providers, where applicable; Support the coordination of self‑inspection system in GWWO, where applicable; Provide support ensuring external audit readiness during external audits and corporate internal audits; Ensure the corrections of findings, risks and recommendations are promptly incorporated into the quality systems; Identify and share “Best Practices”; Participate in investigations of quality system issues and drive CAPA implementation to ensure CAPA findings, risks, recommendations and outcomes are documented and communicated; Trend, analyze and report on quality data to improve product and process quality; develop recommendations based on data analyses.
• Other additional duties may be assigned by the Quality Systems & Compliance Management, if required.

What You'll Bring

• Competence in Microsoft packages specifically Word, Excel and PowerPoint
• Ability to work proactively on own initiative
• Excellent technical writing and analytical skills
• Flexibility
• Results orientated
• Process improvement and procedure writing expertise
• Experience of conducting audits
• Detail‑oriented, well‑organized and able to work independently and in teams
• Good communication skills, verbal and written
• Ability to adapt quickly to change in a fast‑paced environment
• Solid problem‑solving skills
• Previous experience in auditing
• Previous experience in health authorities' audits
• Qualifications: Bachelor's degree (B.A./B.S.) or equivalent
• Two to four years’ experience in the pharmaceutical and/or biotechnology‑based industry (as deemed necessary by hiring manager)
• Experience with assisting or managing QA audits and inspections
• Good working knowledge of pertinent regulations and site SOPs
• Strong communication and facilitation skills
• Certification in auditing preferred
• MSc in a science, pharmacy or related discipline an advantage

Our Benefits Include

• Highly competitive salary
• Annual performance‑based bonus
• Share‑options scheme
• Group pension scheme with company matching contributions
• Private medical insurance
• Ongoing opportunities for career development
• Succession planning and internal promotion opportunities
• Education assistance
• Wellness and social activities
• Collaborative and inclusive working environment

Location: Grange Castle International Business Park, Clondalkin, Dublin, Ireland.