Quality Systems, Compliance Manager

• Lead and manage the site Data Integrity Programme, including SOP governance, compliance assessments, risk management activities, and site-wide data integrity initiatives.
• Support the implementation and continuous improvement of the Grifols Quality Systems & Compliance Programme.
• Ensure compliance with corporate, regulatory, and site requirements.
• Identify compliance risks and recommend improvements to quality systems and processes.
• Manage and coordinate key Quality Systems including: Change Control, Deviations, Corrective and Preventive Actions (CAPA), Supplier Quality Management, Supplier Complaints and Supplier Agreements, Documentation Control, Training Compliance, Quality SAP Processes, Other Quality System activities as required.
• Support compliance activities across the site, including variation submissions, product specification compliance, new product introductions, and implementation of new manufacturing processes.
• Support site readiness for regulatory inspections, customer audits, and corporate audits.
• Coordinate and ensure timely completion of corrective actions arising from audits, inspections, and compliance assessments.
• Participate in investigations of quality system issues and drive effective CAPA implementation.
• Manage the Documentation Compliance Management (DCM) system.
• Oversee QMS document archives and records management activities.
• Generate and communicate site Quality System metrics and compliance reports.
• Support Site Quality Council activities and Annual Product Review processes.
• Analyse and trend quality data to identify opportunities for continuous improvement.
• Support supplier qualification programmes and supplier quality activities.
• Conduct or support supplier and outsourced provider audits as required.
• Coordinate site self-inspection programmes and follow-up activities.
• Support external audit preparation and facilitate audit activities.
• Partner with Manufacturing, Engineering, Supply Chain, Quality Control, Regulatory Affairs, and other functional groups to resolve quality and compliance issues.
• Communicate quality and compliance requirements across the site.
• Identify and share best practices within the organisation and across Grifols manufacturing sites.
• Deliver or coordinate GMP and quality system training where required.
• Lead, coach, and develop Quality Systems & Compliance personnel.
• Foster a culture of accountability, engagement, collaboration, and continuous improvement.

Requirements

• Bachelor's degree in Science, Engineering, Pharmacy, Quality, or a related discipline.
• Significant experience within a regulated pharmaceutical, biotechnology, medical device, or healthcare manufacturing environment.
• Strong working knowledge of Quality Management Systems and GMP requirements.
• Experience managing quality systems such as Change Control, Deviations, CAPA, Document Control, Training, and Supplier Quality.
• Experience supporting regulatory inspections and audit programmes.
• Previous leadership or people management experience is desirable.
• Strong understanding of GMP, Quality Risk Management, and Data Integrity requirements.
• Experience working with electronic Quality Management Systems and SAP.
• Excellent analytical and problem-solving capabilities.
• Strong project management and organisational skills.
• Ability to manage multiple priorities simultaneously.
• Excellent communication and stakeholder management skills.

Core Competencies

Demonstrates expertise in Quality Management Systems, GMP compliance, and Data Integrity within regulated environments. Proven ability to lead quality initiatives, manage audits, and implement continuous improvement strategies.

Highest-signal resume keywords

• Quality Management Systems
• GMP Compliance
• Data Integrity
• Change Control
• Corrective and Preventive Actions (CAPA)

ATS Optimization Keywords Hard Skills

• Quality Risk Management
• Document Control
• Supplier Quality Management
• Training Compliance
• Regulatory Inspection Support
• Quality Data Analysis
• Quality System Metrics Generation
• Supplier Audits
• Continuous Improvement
• Project Management

Soft Skills

• Analytical Problem-Solving
• Communication
• Stakeholder Management
• Organizational Skills
• Leadership

Industry Keywords

• Pharmaceutical
• Biotechnology
• Medical Device
• Healthcare Manufacturing
• Compliance Assessments

Tools & Technologies

• Electronic Quality Management Systems
• SAP