Who we are
We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.
We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way.
Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.
Why Worldwide
We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us!
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%)
We love knowing that someone is going to have a better life because of the work we do.
To view our other roles, check out our careers page at Discover a world of difference at Worldwide! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.
Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful. We’re on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law.