Quality Systems & Compliance Specialist – Pharma/Biotech

PSC Biotech Corporation; Cork; On-site; EUR 40,000 - 60,000; Full time

Job summary

PSC Biotech is a leading Biotech Consultancy in Cork, Ireland, seeking a Quality Systems professional to support External Quality within GEO. The role focuses on overseeing Deviations, CAPAs, Change Controls and QMS compliance.

The position is a 12-month contract with responsibilities spanning metric reviews, governance, and cross-functional collaboration across global sites. Ideal candidates have 1+ year biopharma experience in quality/regulatory settings and strong data skills.

Qualifications

• Bachelor’s Degree in science or engineering (required).
• Minimum 1+ years of biopharmaceutical experience in a Quality, Compliance, and/or Regulatory setting.
• Skilled in data analysis and Excel; Power BI and AI tools experience desirable.
• Strong communication and interpersonal skills—oral, written and presentation.
• Works collaboratively with others to meet shared objectives.

Responsibilities

• Perform Quality Systems Metric Review for GEO and oversee metrics and trending to drive on-time closure of Quality records.
• Support development and implementation of digital improvement initiatives for External Quality.
• Manage routine cross-functional meetings to ensure timely closure of Deviations, CAPAs and Change Control, with leadership endorsement.
• Develop/report metrics and standardize them across the Organization.
• Coordinate monthly governance site quality review team (SQRT) meeting for GEO.
• Deliver training on Quality Management Systems within GEO as required.
• Partner with Global Quality Systems Management Team and cross-functional groups to ensure proper application of the QMS.
• Identify and implement continuous improvement initiatives to External Quality systems.
• Participate in change control program for modifications to qualified systems (within GEO).
• Assist in audits and inspections.
• Participate in development and implementation of global alignment projects with sites.
• Support Self Inspection Programme for External Quality.
• Other duties as assigned

Skills

Data analysis

Excel

Power BI

AI tools

Communication skills

Interpersonal skills

Collaboration

Education

Bachelor’s Degree in science or engineering

Tools

Power BI

AI tools

Job description

PSC Biotech is a leading Biotech Consultancy in Cork, Ireland, seeking a Quality Systems professional to support External Quality within GEO. The role focuses on overseeing Deviations, CAPAs, Change Controls and QMS compliance.

The position is a 12-month contract with responsibilities spanning metric reviews, governance, and cross-functional collaboration across global sites. Ideal candidates have 1+ year biopharma experience in quality/regulatory settings and strong data skills.