Quality Assurance Director

Quality Assurance Director

Hovione

Cork, Ireland

You will be responsible to:

Guarantees cGMP compliance in all activities and systems related to Projects and Products execution. Assures that working practices are streamlined and aligned with the actual needs of each project. Implements policies, procedures and methods to evaluate and to continuously improve the quality of products and operations throughout the products lifecycle. Provides global supplier qualification services in support of new product introduction and existing products. Collaborates with suppliers and Procurement to assure the quality of their products, materials, components and/or operations.

• Ensure that all applicable Quality guidelines and regulations are followed, as appropriate for each product development phase or commercial stage;
• Manage and coordinate own area objectives and Key Performance Indicators, measuring the results and assuring its accomplishment;
• Oversee all QA organization in the Site under his/her responsibility to assure that all applicable procedures, established objectives and approved financial budgets are followed and achieved;
• Be the liaison to all key decisions, plans and rules established by the Corporate Management and ensure implementation as adequate;
• Make decisions on global quality matters with the Quality Director peers and to direct the team in regard to what is the best option whenever there are conflicts of interests;
• Authorize Regulatory inspections at site upon request by Competent Authorities;
• Participate in client’s audits when required;
• Execute internal audits and audits to suppliers with other Hovione members according to the established plans, needs and the criticality of the audits;
• Create an environment where continuous improvement is part of the teams’ activities and drive for the simplification of procedures and daily tasks;
• Manage the TMs assigned to his/her area of responsibility, namely in terms of recruitment, integration, training needs and performance management in accordance with the company's HR policies, in order to ensure all TMs are aligned and motivated towards achieving Hovione's goals, values and culture by promoting their personal and professional development whilst maximizing productivity;
• Develop and propose for approval the short and mid-term goals, annual budget and budget plan in line with the corporate strategy, in order to align activities with Hovione strategic objectives;
• Prepare and propose for superior approval the annual area budget, by defining the allocation of resources necessary for the development of the activity, as well as ensuring the monitoring and control of its evolution, identifying any deviations between the real and the foreseen and taking corrective measures;
• Ensure compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others) within his/her TMs.

We are looking to recruit a Candidate:

• Masters’ degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences or similar scientific field;
• 7-10 years of relevant experience in Pharmaceutical Fine Chemistry areas and coordinating a team;
• Proven leadership experience (5 years +);
• Possess extensive knowledge of Quality, cGMP and global regulations for pharmaceutical manufacturing principles and practices, and is able to lead others on them;
• Fluency in English is a requirement.

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Ireland      Manufacturing and Logistics      Quality Assurance      Hovione