Associate Director, Therapeutic Area Quality Lead(Argentina /Mexico / Colombia)

Worldwide Clinical Trials; Buenos Aires; À distance; ARS 182 485 000 - 273 727 000; Plein temps

Résumé du poste

Worldwide Clinical Trials is seeking an Associate Director, Therapeutic Area Quality Lead to drive quality excellence across global clinical research programs. In this QA leadership role, you will help ensure regulatory compliance, proactively manage risk, and support the delivery of high-quality clinical trials worldwide.

As a trusted partner, you will collaborate with operational leaders, project teams, and sponsor QA to strengthen oversight, promote continuous improvement, and ensure

Qualifications

• Bachelor’s degree in Life Sciences or related field.
• Minimum of 7 years of experience in Quality Assurance, Clinical Research, or a similar GCP-regulated environment.
• Strong knowledge of ICH-GCP, FDA, European, UK, and other global regulatory requirements.
• Experience within a CRO, pharmaceutical, biotechnology, or other regulated life sciences organization.
• Proven ability to assess quality risks, manage complex quality issues, and collaborate with Sponsor QA organizations.
• Experience supporting audits, inspections, CAPAs, and quality governance activities.
• Excellent communication, stakeholder management, analytical, and leadership skills.
• Advanced proficiency in English, both written and verbal.

Responsabilités

• Provide strategic Quality Assurance oversight across assigned therapeutic areas and sponsor portfolios.
• Partner with operational leadership, project teams, and sponsor quality counterparts to strengthen quality performance and regulatory compliance.
• Lead quality governance activities and facilitate effective quality decision-making across clinical research programs.
• Identify, assess, and mitigate quality risks to support successful study execution and patient-focused outcomes.
• Analyze quality metrics and trends to drive proactive improvements and enhance quality performance.
• Support audits, regulatory inspections, and inspection-readiness initiatives across assigned areas.
• Oversee CAPA development, implementation, and effectiveness reviews to ensure sustainable quality outcomes.
• Promote the consistent application of quality standards and global regulatory requirements throughout the clinical trial lifecycle.
• Champion a culture of continuous improvement across cross-functional teams.

Connaissances

Quality Assurance

Clinical Research

Regulatory knowledge

Leadership

Formation

Bachelor's degree in Life Sciences or related field

Description du poste

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!

Make an Impact as an Associate Director, Therapeutic Area Quality Lead at Worldwide

Play a pivotal role in driving quality excellence across global clinical research programs. In this strategic Quality Assurance leadership role, you'll help ensure regulatory compliance, proactively manage quality risks, and support the successful delivery of clinical trials that advance patient outcomes worldwide.

As a trusted quality partner, you will collaborate with operational leaders, project teams, and sponsor quality counterparts to strengthen quality oversight, promote continuous improvement, and support inspection readiness across assigned therapeutic areas and sponsor portfolios.

Your expertise will help foster a culture of quality, enabling teams to identify risks early, resolve complex issues effectively, and maintain high standards throughout the clinical trial lifecycle.

Where You'll Work

This is a remote role open to candidates based in Argentina, Mexico, or Colombia. You will collaborate with global teams across multiple time zones.

Travel domestically and internationally up to 15% as needed.

What You'll Do

• Provide strategic Quality Assurance oversight across assigned therapeutic areas and sponsor portfolios.


• Partner with operational leadership, project teams, and sponsor quality counterparts to strengthen quality performance and regulatory compliance.


• Lead quality governance activities and facilitate effective quality decision-making across clinical research programs.


• Identify, assess, and mitigate quality risks to support successful study execution and patient-focused outcomes.


• Analyze quality metrics and trends to drive proactive improvements and enhance quality performance.


• Support audits, regulatory inspections, and inspection-readiness initiatives across assigned areas.


• Oversee CAPA development, implementation, and effectiveness reviews to ensure sustainable quality outcomes.


• Promote the consistent application of quality standards and global regulatory requirements throughout the clinical trial lifecycle.


• Champion a culture of continuous improvement across cross-functional teams.

What You'll Bring

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, Health Sciences, or a related field.


• Minimum of 7 years of experience in Quality Assurance, Clinical Research, or another GCP-regulated environment.


• Strong knowledge of ICH-GCP, FDA, European, UK, and other global regulatory requirements.


• Experience within a CRO, pharmaceutical, biotechnology, or other regulated life sciences organization.


• Proven ability to assess quality risks, manage complex quality issues, and collaborate effectively with Sponsor QA organizations.


• Experience supporting audits, inspections, CAPAs, and quality governance activities.


• Excellent communication, stakeholder management, analytical, and leadership skills.


• Advanced proficiency in English, both written and verbal.

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.