QA Team Lead - Shop Floor & Environmental Monitoring (EM)

Location: Dublin, IE

Contract Type: Regular Full-Time

Area: Quality

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.

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

QA Team Lead - Shop Floor & Environmental Monitoring (EM) provides leadership and management to two QA operational functions, Shop Floor and Environmental Monitoring, focusing on quality compliance and EM data generation for Albumin Manufacturing. The role ensures operations adhere to GxP standards, supports day to day manufacturing, and drives team development.

What You'll Do

• Maintain the quality of work to be inspection ready in accordance with internal and external cGxP requirements.
• Ensure adherence to GMP, EU Annex 1, FDA, and other applicable regulatory guidelines.
• Support batch certification and ensure all documentation is finalized on time.
• Maintain training and Health & Safety compliance according to company policy.
• Provide performance status to cross functional peers and management via tier/triage structures.
• Support inter team and cross team KPIs aligned with departmental objectives.
• Guide the team's organizational structure and day to day operations.
• Ensure thorough training coverage and develop training materials.
• Act as the team's voice and point of contact for communications.
• Manage resource planning and capacity modeling for hiring.
• Deputize cross shift peer Team Leads or the Supervisor as needed.

Leadership and Managerial

• Provide operational leadership, coaching, mentoring, performance management, and professional development.
• Schedule, monitor, and ensure completion of routine activities within agreed timeframes and regulatory compliance.

QA Shop Floor

• Promote a quality culture through on the job coaching and mentoring in aseptic manufacturing.
• Perform daily GEMBAs and facility walk through audits across Grade A to D areas.
• Support decision making for atypical floor events, including aseptic interventions.
• Assist in in process control and batch reconciliation processes.
• Coordinate air visualization and aseptic process simulations.
• Collaborate on deviation, investigation, CAPA, and change lifecycles with wider QA functions.
• Author, review, and approve documentation such as MBRs, risk assessments, SOPs, and training.
• Monitor KPIs focused on aseptic behaviours, qualifications, and contamination controls.
• Carry out viable and non viable particulate, water, and gas monitoring.
• Analyze environmental data to generate trending reports.
• Support contamination control strategy from an EM perspective.
• Foster stakeholder collaboration with core QA and MFG functions.
• Encourage a LEAN mindset for continuous improvement.
• Provide feedback to foster professional development and an open door culture.
• Perform additional duties as required in consultation with the post holder.

Technical

• Deliver technical expertise on aseptic manufacturing regulations and environmental monitoring.
• Participate in risk assessments and strategic meetings as an SME to ensure proper implementation of new or modified processes.

What You'll Bring

• Experience in a Sterile Pharmaceutical GMP regulated industry with a Quality function.
• Experience with QMS processes in paper based and electronic systems (e.g., Veeva Vault, Trackwise).
• Experience in Grade A, B, C, and D cleanroom environments with RABS technology.
• Experience with deviations, investigations, and CAPAs.
• Problem solving mindset and strong work ethic.
• Excellent verbal and written communication in English.
• Proficiency in Microsoft Office.
• People management experience of two or more persons.
• Project management skills for high priority tasks.
• Sound understanding of EU GMP aseptic manufacture, Annex 1.
• Understanding of ICH Q9 and Q10 Quality Risk Management.
• Experience with an EU regulatory body and inspection exposure.
• Knowledge of Albumin manufacture (purification and aseptic filling in bag).
• Exposure to SAP, KNEAT, and LIMS.
• Strong organizational and coordination ability.
• High attention to detail under pressure.
• Multitasking and priority management.
• Proactive, solution oriented mindset.
• Discretion, reliability, and professionalism with sensitive matters.
• Interpersonal skills for cross functional collaboration.
• Independent work capability with minimal supervision.

Our Benefits Include

• Highly competitive salary
• Annual performance based bonus
• Shares options scheme
• Group pension scheme with company matching
• Private medical insurance for the employee
• ongoing career development opportunities
• Succession planning and internal promotions
• Wellness and social activities

We encourage everyone who meets the qualifications to apply.