Associate Director of Validation

Associate Director of Validation

Grifols

Dublin, Ireland

POSITION SUMMARY:

The Associate Director of Validation will lead and support the qualification and compliance readiness of our new global center for the warehousing, processing, packaging, and worldwide distribution of human blood plasma and plasma derivatives for therapeutic use.

The Associate Director of Validation will be responsible for 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 while ensuring compliance with applicable quality and regulatory requirements, utilizing modern validation principles and standards.

KEY RESPONSIBILITIES

  • Responsible for overseeing Validation schedule planning, test equipment purchasing and maintenance, as well as ensuring the upkeep and availability of all Packaging and Processing equipment, Warehousing and associated facilities at our Dublin Facilities through routine and regular Qualification testing and reporting;
  • Develop, execute, and implement global Validation strategies and management practices for continuous improvement to achieve the highest level of internal and external customer satisfaction, while minimizing operational expenses, capital investment and risk using modern Validation practices;
  • Develop, implement, and maintain a performance dashboard and forum (Validation Council) that includes metrics to clearly identify operational performance, functional goals, key site projects and opportunities for improvement, and be able to provide progress reports to executive management, in support of day to day and Strategic activities;
  • Oversee the day to day operations of the Validation group, evaluating performance towards the achievement of validation, production and packaging goals while maintaining worldwide regulatory compliance and minimizing errors;
  • Fosters a collaborative approach, ensuring cross functional reviews are conducted across all departments to deliver best in class performance for GWWO;
  • Serve as an internal resource in matters related to global Validation practices and value add activities. Support cost reduction initiatives and compliance standards in contractor selection and approvals where applicable;
  • Participate in regulatory and internal inspections/audits including providing written responses as applicable for areas of responsibility. Maintain currently knowledge of regulatory and industry standards, trends and advancements through independent reading and training;
  • Responsible for development of staff, including training and motivating in a manner that promotes the achievement of company and department business goals and objectives;
  • Address complaints and resolve employee related problems with the collaboration of Human Resources;
  • Build organisational competency and succession plans. Involved in interviewing/selection process of hiring or promoting department personnel;
  • Develop and lead cross collaboration with other Grifols Network sites, ensuring knowledge sharing and best practices are adopted and shared to drive efficiencies, cost reduction and robustness for our equipment, manufacturing practices and facilities.

PERSON SPECIFICATION

  • Minimum 10 years relevant experience in pharmaceutical/biologics operations including Validation management, Processing and packaging operations and qualification, operation and continuous monitoring of new manufacturing facilities;
  • Expertise in Validation practices, philosophy’s and knowledge of cost drivers for plasma and plasma derivatives facility qualification and upkeep;
  • Experience in strategic business continuity planning, and risk assessments a plus;
  • Strong knowledge of cGMPs and industry guidelines, as well as international regulatory guidelines required to support and maintain the production, packaging and distribution of human blood plasma from a validation and qualification perspective;
  • Excellent verbal and written communication, must be able to read, write and speak English;
  • Strong interpersonal skills with ability to interact with all levels of personnel in a professional manner;
  • Demonstrated leadership skills with ability to motivate, guide, train, coach and develop subordinates;
  • Strong organisational, analytical, problem solving and spreadsheet skills, including cost modelling. Ability to analyse detail and perform structured decision making daily;
  • Ability to manage multiple projects simultaneously, meet deadlines, and handle and everchanging, fast paced critical work environment;
  • Ability to read and understand specification sheets, drawings, regulations (cGMP, QS, ISO);
  • Willing to travel domestically and internationally up to 10%;
  • Bachelor’s degree in Mechanical, Chemical Engineering, Manufacturing Engineering, Validation or Operations Management, Material Science or closely related scientific/technical discipline or qualification.

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