Select how often (in days) to receive an alert: Create AlertWould 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:Directs the activities, administration, and control of various Quality Assurance activities for biological products manufactured by Grifols Worldwide Operations (GWWO) and/or other Grifols affiliates. Responsibilities include: providing quality direction to ensure timely product release and that each product meets the quality standards of safety and efficacy; establishing policies, practices, procedures, and specifications applicable to the manufacture and release of biological products; and providing technical direction and general leadership while serving as a liaison with local and international regulatory agencies.KEY RESPONSIBILITIES:Support for Quality Assurance Department.Directs quality assurance business unit functions for GWWO and/or other Grifols affiliates.Directs the establishment of Quality Operations policies, systems, procedures, and specifications for raw materials, in-process materials, and finished products in accordance with high standards.Establishes Quality Operations systems and practices to ensure compliance with current GMP regulations and corporate requirements.Directs the development of specifications and methods to assure the approval of IND/NDA/PLAs for products researched for GWWO.Directs Quality Operations activities to ensure that clinical supplies meet regulatory requirements for Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).Participates in the technical review process and approves all new or modified products before submission for HPRA approval and/or release to the market.Approves all Quality Assurance and production procedures to ensure compliance with current cGMP regulations.Coordinates activities of various departments to make appropriate recommendations for product recalls as needed.May provide technical direction, general leadership, and act as a liaison to other Grifols Inc. locations on Quality-related issues.Recommends removal of unsatisfactory products from the market and ensures effectiveness of returns.Represents Technical Director in delegated responsibilities.Assumes responsibility for GWWO product issues in the absence of the Technical Director.Regularly interacts with cross-functional senior management and builds business partnerships with peers, customers, and vendors.Manages one or multiple departments through subordinate managers, guiding them to achieve tactical and strategic goals.Sets goals and budgets consistent with company financial practices and standards, developing cost/benefit analyses for major expenditures.PERSON SPECIFICATION:Demonstrated strong leadership skills and managerial experience in a regulated environment.Knowledgeable in scientific disciplines to direct Ph.D. level personnel in product or process problem-solving.Familiar with government regulations worldwide to assure the development of compliant Quality systems.Excellent strategic and tactical decision-maker.Aligns with corporate strategic vision and encourages informed risk-taking.Experience using SAP.Strong understanding of pharmaceutical quality processes and systems.Experience with Statistical Process Control (SPC).Qualifications:MSc in Industrial Pharmaceutical Science and eligible for Qualified Person status.KEY COMPETENCIES:Strong understanding of biology, chemistry, and microbiology.Excellent people skills to influence and motivate staff and peers.Strong delegation skills to oversee and lead the quality assurance group.Solid problem-solving skills and excellent technical writing abilities.Excellent presentation skills and competence in Microsoft Office.Ability to work proactively and independently.Results and detail-oriented with process improvement expertise.Flexible and able to adapt quickly to change in a fast-paced environment.Willing to travel as required.Our Benefits Include:Highly competitive salary.Group pension scheme - Contribution rates are 5% employer and 5% employee.Private Medical Insurance for the employee.Ongoing opportunities for career development in a rapidly expanding work environment.Succession planning and internal promotions.Wellness activities - Social activities e.g., Padel, Summer Events.We encourage everyone who meets the qualifications to apply – we're excited to hear from you.#LI-FD1Location: Grange Castle International Business Park, Grange, Co. Dublin, D22 K2R3
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