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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.
The Director of Validation will lead and support the qualification and compliance readiness of our global centre for the warehousing, processing, packaging, and worldwide distribution of human blood plasma and plasma derivatives for therapeutic use. This role involves directing Grifols Worldwide Operations (GWWO) validation programme in accordance with current GMP and quality standards to ensure the qualification of equipment, utilities, processes, facilities, and supporting manufacturing systems.
Key responsibilities include developing validation strategies, policies, procedures, and project requirements in collaboration with senior and executive management across Manufacturing, Regulatory Affairs, Quality Operations, Technical Operations, Engineering, Technology, and Scheduling & Planning. The Director will also provide direct leadership over the Validation and Air Filtration System departments, focusing on maintaining and improving the robustness and availability of our equipment, facilities, and systems to meet Grifols' global business and customer needs. Ensuring compliance with applicable quality and regulatory requirements, utilising modern validation principles and standards, is essential.
KEY RESPONSIBILITIES
1. Validation Strategy & Compliance
• Global Validation Strategy:
Develop and implement global validation strategies aligned with company objectives, focusing on continuous improvement in operational efficiency, customer satisfaction, and regulatory compliance. Ensure minimisation of operational costs, capital investment, and risks through modern validation practices.
• Regulatory Compliance:
Ensure the Validation program adheres to Good Manufacturing Practices (GMP) and quality standards for equipment, utilities, processes, facilities, and manufacturing systems. Collaborate with senior management from Manufacturing, Regulatory Affairs, Quality Operations, Technical Operations, Engineering, and other departments to develop strategies and procedures that comply with US, European, Canadian, HPRA, and other regulatory requirements.
• Audit Preparation & Compliance:
Prepare and present validation documentation for internal and external regulatory audits, including those by the FDA, German Central Authority (GCA), Paul Ehrlich Institute (PEI), Canadian Blood Services (CBS), HPRA, and others. Develop and implement responses to audit observations for validation concerns.
• Protocol & Report Review:
Review and approve validation protocols and reports to ensure all regulatory and quality requirements are met and maintained. Address any validation deviations and implement corrective actions as necessary.
2. Project Management & Oversight
• Capital Project Validation:
Manage validation activities for large-scale capital projects, including Turnaround projects, involving multiple protocols or validation plans. Supervise contractors and specialists as required. Work with the Project Director to develop cost estimates and manage the validation budget for these projects.
• Cross-Functional Leadership:
Direct the activities of cross-functional teams (e.g., construction, validation, process transfer) to ensure alignment with company and site objectives, meeting project milestones and regulatory expectations.
• Change Control & Impact Assessment:
Review and approve proposed changes to validated systems and procedures, assessing the potential impact on validation status and ensuring appropriate management of any changes.
3. Validation Program Development & Execution
• Cleaning & Revalidation Programs:
Develop and implement cleaning monitoring programs and revalidation procedures for manufactured products to ensure compliance throughout the product lifecycle.
• Product Reviews & Validation Master Plans:
Prepare product reviews related to validation changes/impacts and create Validation Master Plans (VMPs) and Continued Process Validations (CPVs) to meet regulatory expectations.
4. Staff Development & Leadership
• Team Leadership:
Lead the Validation department by fostering a culture of growth and accountability. Provide ongoing training and motivation for staff to achieve both department and company goals.
• Staff Recruitment & Development:
Oversee the recruitment, hiring, and promotion of personnel within the department. Participate in succession planning to ensure organizational competency and long-term success.
• Employee Relations:
Address employee-related issues, complaints, and conflicts in collaboration with Human Resources to ensure a positive and productive work environment.
5. Operational Performance & Reporting
• Performance Management & Reporting:
Establish and maintain a performance dashboard and Validation Council to track key performance metrics, functional goals, site projects, and opportunities for improvement. Provide regular progress reports to executive management, supporting both day-to-day operations and long-term strategic initiatives.
• Global Validation Leadership:
Maintain accountability for global and local validation decisions, policies, procedures, and projects. Oversee a team of validation managers and specialists while managing the departmental budget.
6. Cross-Site Collaboration
• Knowledge Sharing & Best Practices:
Lead collaboration efforts with other Grifols Network sites to ensure knowledge sharing and the adoption of best practices that improve equipment efficiency, manufacturing practices, and facilities management across the global network.
PERSON SPECIFICATION
- Industry Expertise and Experience: A minimum of 10 years’ experience in pharmaceutical/biologics operations, including validation management, processing, packaging operations, and qualification of new manufacturing facilities. Expertise in the qualification, operation, and continuous monitoring of plasma and plasma derivative facilities.
- Validation Practices and Philosophy: Strong expertise in validation practices and philosophies, with a particular focus on the cost drivers for plasma and plasma derivative facility qualification and ongoing maintenance.
- Regulatory Knowledge: In-depth knowledge of cGMPs, international regulatory guidelines (FDA, EMA, HPRA etc.), and industry standards for validation, qualification, production, packaging, and distribution of human blood plasma and related biologics.
- Business Continuity and Risk Management: Experience in strategic business continuity planning and risk assessments, with the ability to manage and mitigate potential risks in the validation and qualification processes.
- Technical Knowledge: Extensive knowledge of equipment design/operation, commissioning, facilities (including material and personnel flow), utilities (purified water, clean steam, compressed air, gases), filtration (sterile, depth, filter presses), and purification (chromatography, ultrafiltration, nanofiltration).
- Sterilisation and Clean Systems: Expertise in steam sterilisation, clean-in-place systems, vessels, instrumentation (laboratory, in-line/process), and automation systems. Strong experience in validating sterilisation and purification systems in compliance with regulatory standards.
- Leadership and Management: Proven leadership capabilities, with the ability to motivate, guide, train, and develop teams. Strong communication skills, with the ability to interact professionally with personnel at all levels across the organisation.
- Project Management: Ability to manage multiple projects simultaneously, meet deadlines, and work effectively in a fast-paced, constantly evolving environment. Strong organisational, analytical, and problem-solving skills, with a focus on structured decision-making.
- Communication and Interpersonal Skills: Excellent verbal and written communication skills, with fluency in reading, writing, and speaking English. Strong interpersonal skills, with the ability to engage with all levels of personnel in a professional and approachable manner.
- Risk Analysis and Cost Modelling: Ability to perform cost modelling, analyse details, and understand cost drivers to ensure efficient resource allocation and adherence to budgetary guidelines. Ability to interpret specification sheets, drawings, and regulations (cGMP, QS, ISO).
- Global Experience and Travel: Willingness to travel domestically and internationally up to 10% of the time.
- Educational Background: A Bachelor’s degree in Mechanical, Chemical Engineering, Manufacturing Engineering, Validation or Operations Management, Material Science, or a closely related scientific/technical discipline.
- Continuous Professional Development: Commitment to staying updated with industry trends, regulatory changes, and best practices by attending external training, participating in professional memberships, and reviewing scientific and regulatory journals.
Our Benefits Include:
- Highly competitive salary
- Group pension scheme - Contribution rates are (1.5% / 3%/ 5%/ 7%) and company will match
- Private Medical Insurance for the employee (Irish Life)
- Ongoing opportunities for career development in a rapidly expanding work environment
- Succession planning and internal promotions
- Education allowance
- Wellness activities - Social activities eg. Padel, 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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