Quality Management Associate - North America/Europe - 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 Quality Assurance department sets the bar high when it comes to quality. We are committed to exceeding the quality standards required by our sponsors, study participants, and regulatory authorities. Our QA culture is based on an environment where staff are trained, energized, and empowered to deliver high-quality products to our employees and customers.

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.
• 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.
• Provides consultancy and reviews project-specific Quality Management Documents (QMDs) deviations.
• Performs study data review and trending activities as assigned.
• Collaborates with Risk Based Quality Management to support ongoing risk assessment as assigned.
• May support the oversight and follow-up of CAPA Plan execution for functional and/or corporate QIs.
• 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.
• 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.
• 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.
  
  

Your Experience

• College / University degree or equivalent in nursing, biological, physical, health, pharmacy, or other related science and 2+ years of relevant GCP experience.
• GcLP, GLP, GVP and GPP experience is an asset.
• Working knowledge of ICH Guidelines, FDA Code of Federal regulations, European Directives, and UK Statutory Instruments relevant to GCP .
• Understanding of the Drug Development Process.
• IT literate, experienced with Microsoft based applications, including proficiency in Excel, Word, SharePoint, and PowerPoint.
• 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.