What are the responsibilities and job description for the Director, Bioanalytical and Clinical Lab Quality IN OFFICE AUSTIN, TX position at Worldwide Clinical Trials?
What the Director, Bioanalytical and Clinical Lab Quality does at Worldwide
The Director, Bioanalytical Lab Quality is responsible for the oversight, planning, execution, reporting and quality management of the QA activities in Bioanalytical and Clinical Worldwide Laboratories
What you will do
- Direct and leads quality activities to provide assurance that data and operational activities are in compliance with regulations, guidelines and laws.
- Implement and deliver of internal systems and study specific audits
- Review and approval of Quality and study related documents
- Define, monitor, track and report Key Quality Indications (KQI) for the Bioanalytical Lab
- Lead/Participate in the development and review of Quality Management Documents including SOPs and work instructions
- Serve as the Lead and oversee the management, planning, hosting, reporting, documentation and follow up of all
- Regulatory Inspections and Sponsor audits of Bioanalytical lab per Audits and Inspection Program (AIP) requirements
- Responsible for leading and maintaining CAP accreditation for clinical lab
What you will bring to the role
- Ability to lead a team of individuals with a clear vision and defined purpose
- Excellent organizational leadership competences, inclusive of scheduling and leading team meetings that are effective, efficient, and documented
- Excellent project management and decision-making skills
- Ability to implemented risk management strategies
- Previous experience with leading/participating in FDA BIMO inspections, MHRA GCP inspections, Health Canada GCP inspections, EMA GCP inspections, and other international Regulatory inspections is required
- Working knowledge of ICH Guidelines, FDA regulations, European Directives, and local regulations.
Your experience
- Expert in GLP and GCLP requirements for regulatory compliance in Clinical and Bioanalytical laboratories. Working knowledge of other GxPs to include GCP and GMP
- Extensive experience of Bioanalytical and clinical laboratory operations
- Knowledge of method development and validation
- Experience with quality oversight of equipment and computer system validation
- Ability to speak, read and write English fluently
- Excellent working knowledge of Quality Management Systems, ICH Guidelines, FDA Code of Federal regulations,
- European Directives and Regulations, and UK Statutory Instruments relevant to GCP
- Excellent understanding of drug development processes
- Experience in supporting Regulatory Inspections is an asset, but not essential
- IT literate, experience with Microsoft based applications, including proficiency in Excel, Word, SharePoint, and PowerPoint
- M.S or equivalent in a scientific or allied health field and 5 years of relevant GCP, GcLP, GLP, GVP and GPP experience OR
- Bachelor’s degree or equivalent with concentration in biological, physical, health, pharmacy or other related science and 7 years of relevant GCP, GcLP, GLP, GVP experience
- Domestic and international travel may be required (not exceeding 15%)
