Associate Director, Therapeutic Area Quality Lead - Americas/EMEA - 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 Quality Assurance Does At Worldwide

The Quality Assurance department sets the bar high when it comes to quality. We are committed to exceeding 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 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 Subject Matter Expert (SME), providing GCP consultancy to project teams within the assigned Therapeutic Area (TA) and for assigned functional area(s).
• Performs TA and study data review and trending activities.
• Collaborates with Risk Based Quality Management to support initial and ongoing risk assessment.
• Provides Clinical Investigator Site inspection and audit support as required.
• Provides GCP consultancy and reviews QMD deviations for project teams within the assigned TA and within the GCP consultancy SME area.
• Responsible for QA review of Quality Management Documents (QMDs) within GCP consultancy SME area during revisions or regular review cycles.
• Responsible for the QA-to-QA relationship with Sponsor QA counterparts within the TA, including management of Quality Agreements and quality metrics.
• Manages the business/operational relationship between QA and with the operational and TA leadership.
• May assist with Sponsor audits and regulatory inspections as assigned.
  
  

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 excellent critical thinking skills.
• Demonstrates the ability to successfully plan, adjust, manage, and optimize all resources for the advancement of QA goals and objectives.
• Competent to manage projects/teams of significant scope and complexity with enthusiasm, prioritizing workload with attention to detail while meeting all deliverables and timelines.
• Works independently, takes initiative and has a flexible approach to work assignments and other assigned tasks.
• Strong influencing and negotiation skills.
  
  

Your background

• M.S. or equivalent in a scientific or allied health field and 5+ years of relevant GCP, GcLP, GLP, GVP and GPP experience
• Bachelor’s degree or equivalent with concentration in biological, physical, health, pharmacy or other related science and 7+ years of relevant GCP, GLP, GVP experience
• Possesses broad experience related to understanding the principles and application of quality and regulatory compliance related to GxP activities, specifically GCP
• 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
• 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.