Senior QC Manager

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

We understand that self-doubt can hold talented individuals back from applying for opportunities. We encourage everyone who meets the qualifications to apply – we're excited to hear from you

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