Senior Quality Management Associate (Fixed Term) - Europe/North America - Remote

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 Quality Assurance Department Does At Worldwide

The Senior Quality Management Associate (Senior QMA) is responsible for the oversight, delivery, maintenance, reporting, and follow up of assigned QA activities.

What You Will Do

• Champions the adoption of the Quality Management System (QMS)
• Provides consultancy and oversight for project-specific Quality Issues (QIs) and Corrective and Preventive Action (CAPA) Plans
• Provides consultancy and oversight for functional and/or corporate QIs as assigned
• Maintains up to date electronic filing and management for QI and CAPA related documentation
• Acts as GCP/GLP/GcLP Subject Matter Expert (SME), provides GCP/GLP/GcLP consultancy to project teams and for assigned functional area(s)
• Performs study data review and trending activities as assigned
• Collaborates with Risk Based Quality Management to support ongoing risk assessment as assigned
• Provides consultancy and reviews project-specific Quality Management Documents (QMDs) deviations as assigned
• Responsible for QA review of assigned QMDs during revisions or regular review cycles
• Works collaboratively with the Quality Lead (Therapeutic Area Quality Lead, Bioanalytical Quality Lead, or Phase 1 Clinic Quality Lead)
• May assist with Sponsor audits and regulatory inspections as assigned
• Acts as mentor to Quality Management Associates
• Performs other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not all-inclusive
  
  

What You Will Bring To The Role

• Communicates professionally, concisely, clearly, and consistently to external and internal customers both verbally and in writing
• Customer focused approach to work
• Demonstrates critical thinking skills
• Serves as a positive QA ambassador during all daily activities and customer interactions
• Competent to manage projects/teams of significant scope and complexity with enthusiasm, prioritizing workload with attention to detail while meeting all deliverables and timelines
• Demonstrates an ability to effectively communicate and influence the outcomes of the decision-making process
• Works with a sense of urgency and recognizes and delivers on time sensitive deliverables
• Works independently, takes initiative and has a flexible approach to work assignments and other assigned tasks
• Adheres to Worldwide Travel Policy
  
  

Your Experience

• Possesses broad experience related to understanding the principles and application of quality and regulatory compliance related to GxP activities, specifically GCP
• 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
• Working knowledge of the Drug Development Process
• IT literate, experienced with Microsoft based applications, including proficiency in Excel, Word, SharePoint, and PowerPoint
• College / University degree or equivalent in biological sciences, nursing, pharmacy, or other related science and 4+ years of relevant GCP experience
• GcLP, GLP, GVP and GPP experience is an asset
• Domestic and international travel may be required (not exceeding 10%)
  
  

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.