What are the responsibilities and job description for the Director, Quality / Site Quality Head position at Thermo Fisher Scientific?
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
COMPANY: Thermo Fisher Scientific Inc.
LOCATION: 2110 E. Galbraith Road, Cincinnati, OH 45237
TITLE: Director, Quality / Site Quality Head
HOURS: Monday to Friday, 8:00 am to 5:00 pm
DUTIES: Provide overall direction and guidance to the Quality organization.
Ensure the site complies with all company policies, standards and all applicable cGMP regulations and requirements applicable to the sites pharmaceutical manufacturing.
Set strategy and direction for Quality organization in alignment with Thermo Fisher’s vision and goals.
Ensure efficient operation of the Quality Control laboratory to support client expectations, project deliverable and financial objectives.
Ensure all elements of the people plan are executed including hiring, on-boarding, developing and coaching staff and succession planning.
Host all Regulatory inspection and liaise and with regulatory bodies such as FDA and EMA.
Establish and report Quality KPIs to monitor the business and respond to underperformance.
Provide technical support to pharmaceutical sales, client sales, Pharmaceutical Development Services (PDS), Operations and individual client groups.
Plan, manage and prioritize the Quality budget and allocate workload and resources (system, equipment, FTEs) to meet compliance and business requirements.
Travel: Up to 10% domestic and international travel required.
REQUIREMENTS: MINIMUM Education Requirement: Bachelor’s degree in Pharmaceutical Science, Physical Science, Biological Science, or related field of study.
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.
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