<p>Work Schedule</p> <p>Standard (Mon-Fri)</p> <p>Environmental Conditions</p> <p>Office</p> <p>Job Description</p> <p>COMPANY: Thermo Fisher Scientific Inc.</p> <p>LOCATION: 2110 E. Galbraith Road, Cincinnati, OH 45237</p> <p>TITLE: Director, Quality / Site Quality Head</p> <p>HOURS: Monday to Friday, 8:00 am to 5:00 pm</p> <p>DUTIES: Provide overall direction and guidance to the Quality organization.</p> <p>Ensure the site complies with all company policies, standards and all applicable cGMP regulations and requirements applicable to the sites pharmaceutical manufacturing.</p> <p>Set strategy and direction for Quality organization in alignment with Thermo Fisher's vision and goals.</p> <p>Ensure efficient operation of the Quality Control laboratory to support client expectations, project deliverable and financial objectives.</p> <p>Ensure all elements of the people plan are executed including hiring, on-boarding, developing and coaching staff and succession planning.</p> <p>Host all Regulatory inspection and liaise and with regulatory bodies such as FDA and EMA.</p> <p>Establish and report Quality KPIs to monitor the business and respond to underperformance.</p> <p>Provide technical support to pharmaceutical sales, client sales, Pharmaceutical Development Services (PDS), Operations and individual client groups.</p> <p>Plan, manage and prioritize the Quality budget and allocate workload and resources (system, equipment, FTEs) to meet compliance and business requirements.</p> <p>Travel: Up to 10% domestic and international travel required.</p> <p>REQUIREMENTS: MINIMUM Education Requirement: Bachelor's degree in Pharmaceutical Science, Physical Science, Biological Science, or related field of study.</p> <p>MINIMUM Experience Requirement: 10 years of GMP experience in the pharmaceutical industry, or related experience. Required knowledge or experience with: cGMPs and pharmaceutical manufacturing, Quality Assurance, Compliance, Quality Control and Regulatory Affairs; Mentoring and leading staff in crisis situations and through long term cultural change and business development; Driving functional, technical and operational excellence; Inspiring and championing innovation, teamwork, transparency and team effectiveness; Tackling complex problems; and Experience leading testing departments or testing functions, managing large and complex activities and processes.</p> <p>#LI-DNI</p>