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 Senior Director, Quality Management System does at Worldwide
- Primary responsibility to adapt current QMS and to design and execute the strategic QMS/eQMS to ensure that it is fit for purpose to support GxP requirements in CRO, Clinic and laboratory environments
- Review of QMS actions and liaison with operations and quality staff
- Enable and lead the QMS team and representatives
- Coordinate and oversight of Quality compliance QMS LS meetings to build and develop understanding of QMS requirements and improve quality metrics
- Develop and report KPI’s and KQIs for LS, Clinic and BA Lab
- Develop QMS training materials and/or deliver training as required in compliance with Worldwide processes.
- Provision of QMS metrics – by type of Quality data ( issues, deviations, CAPAs), operations and where required by study Reduce recurring CAPA and CAPA lifecycle time
- Strategic oversight of the Quality Management Document system (QMD) ensuring processes are optimized, improved, streamlined and in compliance with regulatory requirements and guidelines and local laws.
- Design, develop and support QMDs required for operational excellence across all operations at Worldwide
- Maintain QMS Global Calendar for all QSE Chair Meeting, QSE-GC Meetings
- Support GxP Regulatory Inspections and sponsor audits as required by serving as the SME for the QMS
What you will bring to the role
- Demonstrated knowledge and experience with managing QMS in a dynamic research environment
- Demonstrated organizational leadership competencies
- Demonstrated ability for driving results and role modeling as a cross functional collaborator Demonstrated ability to effectively communicate, escalate, and influence the outcomes of decision-making process to both internal and external customers
- Demonstrated project management and decision-making skills
- Demonstrated ability to think critically and lead calmly in complex situations, with strong decision-making skillset
- Acts without authority to drive performance and accountability. Works with a sense of urgency; ability to recognize time sensitivity and leads assertively
- Ability to lead a team of individuals with a clear vision and defined purpose
Your experience
- Bachelor’s degree or equivalent is required. MS in a scientific or allied health field preferred Minimum of 10 years of relevant GxP experience
- Successful previous experience in the development and execution of a GCP Quality Management System
- Possesses broad expertise related to understanding the principles and application of quality and regulatory compliance related to GxP activities
- Advanced understanding of the principles for a GxP Quality Management System
- Advanced working knowledge of ICH Guidelines, FDA regulations, European Directives, UK Statutory Instruments, AIFA CRO Decree
- Advanced understanding of the Drug Development Process
- Understanding of 21 CFR Part 11 regulations and other international guidelines specifically addressing Computer Systems Electronic Record/Electronic Signature
- Domestic and international travel required (approximately 10-15%)
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 www.worldwide.com/careers! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.
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
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