Senior QC Manager

Grifols; Dublin; On-site; EUR 120,000 - 180,000; Full time

Benefits offered by this job

Group pension

Private medical insurance

Wellness programs

Job summary

Grifols Worldwide Operations seeks a Senior Manager of Quality Control to lead QC activities, ensure GMP compliance, and drive continuous improvement across analytical testing and environmental monitoring. You will partner with cross-functional teams to support manufacturing, validation, and regulatory readiness.

The role emphasizes strong leadership, data integrity, and experience supporting regulatory inspections within a biotech/pharma setting.

Qualifications

• Bachelor's degree in a scientific discipline relevant to GMP pharmaceutical manufacturing.
• Significant GMP-regulated pharmaceutical/biotech experience.
• Extensive experience leading Quality Control laboratory operations.
• Proven leadership and people-management experience.
• Strong knowledge of EU GMP, FDA regulations and data integrity.

Responsibilities

• Provide leadership and strategic direction for Quality Control activities.
• Oversee QC testing, environmental monitoring, and release support to manufacturing.
• Ensure inspection readiness and effective regulatory submissions.

Skills

Leadership

Quality Control

GMP compliance

Data integrity

Regulatory inspections

Analytical testing

Cross-functional collaboration

Project management

Education

Bachelor's degree in Chemistry / Microbiology / Pharmaceutical Sciences

Advanced degree in a scientific discipline

Tools

Laboratory automation

Digital transformation

Job description

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

At Grifols, we believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunities that foster an inclusive environment.

Position Summary

The Senior Manager, Quality Control is responsible for the leadership, management, and strategic direction of Quality Control activities at Grifols Worldwide Operations (GWWO). The role ensures that laboratory operations support the manufacture, testing, release, stability monitoring, validation activities, and ongoing compliance of plasma-derived medicinal products through the delivery of accurate, reliable, and timely analytical results. The position is accountable for ensuring all Quality Control activities are conducted in compliance with current GMP requirements, regulatory commitments, marketing authorisations, pharmacopoeial standards, and Grifols Quality System requirements. The Senior Manager, Quality Control provides leadership to QC teams, drives continuous improvement initiatives, ensures inspection readiness, and fosters a culture of quality, compliance, and operational excellence.

What You Will Do

Quality Control Leadership

• Provide leadership, direction, coaching, and development for Quality Control personnel.
• Establish departmental objectives and performance measures aligned with site and corporate quality goals.
• Build and maintain a culture of quality, compliance, accountability, and continuous improvement.
• Ensure adequate staffing, succession planning, and employee development within the QC organization.
• Manage departmental budgets and resources to support business objectives.

Laboratory Operations

• Oversee all Quality Control testing activities including raw materials, utilities, in-process samples, environmental monitoring, validation studies, stability programs, and finished product testing.
• Ensure laboratory testing supports manufacturing schedules and product release timelines.
• Monitor laboratory performance and implement actions to improve efficiency and effectiveness.
• Ensure laboratory procedures, methods, and specifications remain current and compliant.

GMP Compliance and Quality Systems

• Ensure Quality Control operations comply with EU GMP, FDA requirements, relevant pharmacopoeias, and Grifols procedures.
• Provide oversight of deviations, CAPAs, change controls, investigations, and quality risk management activities relating to Quality Control.
• Ensure effective management of laboratory documentation and record retention activities.
• Support Product Quality Reviews, Management Reviews, and Quality System monitoring activities.

Data Integrity

• Ensure implementation and maintenance of ALCOA++ principles across all Quality Control activities.
• Provide oversight of laboratory computerized systems and electronic data management.
• Ensure data governance practices comply with regulatory expectations and company procedures.
• Lead and support investigations associated with laboratory data integrity events.

Regulatory Inspection and Audit Support

• Maintain a continuous state of inspection readiness within the Quality Control organization.
• Support regulatory inspections, customer audits, and internal audits.
• Present Quality Control systems, procedures, investigations, and performance metrics during inspections.
• Ensure timely completion of actions resulting from inspections and audits.

Technical and Scientific Oversight

• Provide technical leadership for analytical and microbiological testing programs.
• Support method transfer, validation, verification, and lifecycle management activities.
• Ensure environmental monitoring and contamination control programs remain effective and compliant.
• Partner with Manufacturing, Quality Assurance, Validation, Engineering, Regulatory Affairs, and other departments to resolve technical and quality issues.

Laboratory Systems and Equipment

• Ensure laboratory equipment and computerized systems remain qualified, calibrated, and fit for intended use.
• Support acquisition, implementation, qualification, and lifecycle management of laboratory technologies.
• Ensure laboratory facilities are maintained in accordance with GMP requirements.

Continuous Improvement

• Drive initiatives that improve quality, compliance, efficiency, and laboratory effectiveness.
• Utilize quality metrics and trend analysis to identify risks and opportunities.
• Support digital transformation and laboratory modernization initiatives.
• Promote innovation while ensuring regulatory compliance.

What You’ll Bring

• Bachelor's Degree in Chemistry, Microbiology, Pharmaceutical Sciences, Biochemistry, Biological Sciences, or a related scientific discipline.
• Significant experience within a GMP-regulated pharmaceutical, biotechnology, or biologics manufacturing environment.
• Extensive experience leading Quality Control laboratory operations.
• Demonstrated leadership and people management experience.
• Thorough knowledge of EU GMP, FDA regulations, data integrity principles, and laboratory compliance requirements.
• Advanced degree in a scientific discipline.
• Experience supporting regulatory inspections and customer audits.
• Experience with aseptic manufacturing and biological products.
• Experience implementing laboratory automation or digital transformation initiatives.
• Strong leadership and people-management skills.
• Excellent organizational and decision-making capabilities.
• Advanced knowledge of GMP regulations and Quality Systems.
• Strong analytical, problem-solving, and investigation skills.
• Effective communication and stakeholder management skills.
• Ability to lead cross-functional teams and influence positive outcomes.
• Commitment to patient safety, product quality, and regulatory compliance.
• Strong understanding of contamination control, microbiological monitoring, and laboratory data integrity requirements.

Our Benefits Include

• A highly competitive salary package
• Group pension scheme - Contribution rates are (3%/ 5%/ 7%) and company will match
• Private medical insurance for the employee
• Ongoing career development opportunities within a rapidly growing organisation
• Strong focus on succession planning and internal promotion
• Dedicated education and professional development allowance
• Wellness and social initiatives, including activities such as padel and summer events

Location: Grange Castle International Business Park, Grange, Co. Dublin, D22 K2R3