Senior / QA Project Lead - US/Canada/UK/Spain - Remote

Worldwide Clinical Trials Limited spółka z ograniczoną odpowiedzialnością; Charlotte (NC); Hybrid; USD 90,000 - 130,000; Full time

Job summary

Worldwide Clinical Trials seeks a Senior QA Project Lead to ensure compliance with clinical trial regulations while leading quality assurance efforts. You will manage investigations into quality issues and facilitate corrective action plans, working collaboratively with project teams to support regulatory inspections and uphold high standards in patient care.

Qualifications

• 5+ years of relevant GCP experience or 3+ years with M.S. in a scientific field.
• Excellent knowledge of Quality Management Systems and ICH Guidelines.
• Experience supporting Regulatory Inspections is preferred.

Responsibilities

• Ensure compliance with study protocols and regulations.
• Manage investigations for Quality Issues (QIs) and develop CAPA plans.
• Collaborate with project teams and provide GCP consultancy.

Skills

Communication

Project Management

Negotiation

Compliance

Education

Bachelor's degree in biological, physical, health, pharmacy, or related science

Job description

Senior / QA Project Lead - US/Canada/UK/Spain - Remote page is loaded

Senior / QA Project Lead - US/Canada/UK/Spain - Remote

Apply locations Virtual United States North Carolina Virtual Canada Ontario Virtual Spain Madrid Virtual United Kingdom Virtual Spain Barcelona time type Full time posted on Posted 2 Days Ago job requisition id JR101048

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

• Collaborate with project team members to ensure compliance with study protocols and regulations.

• Acts as GCP Subject Matter Expert (SME) providing GCP consultancy to project teams for assigned projects.

• Manages and facilitates investigation and root cause analysis for Quality Issues (QIs) including development of Corrective and Preventive Action (CAPA) Plans for assigned projects.

• Participates in risk management activities.

• Proactive identification of risks to ensure mitigations and controls are in place.

• Performs quality assurance review and trending activities for assigned projects.

• Provides Clinical Investigator Site inspection and audit support as required.

• Provides GCP consultancy and reviews QMD deviations for project teams.

• Collaborate with Therapeutic Area Quality Leads within the QMO team and support with managing the QA-to-QA relationship with Sponsor QA counterparts and quality metrics.

• Assist with Sponsor audits and regulatory inspections as assigned.

What you will bring to the role

• Professional, concise, clear, and consistent communication and approach for internal and external customers.

• 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.

• Works independently, takes initiative and has a flexible approach to work assignments and other assigned tasks.

• Works with a sense of urgency and recognizes and delivers on time sensitive deliverables.

• Strong influencing and negotiation skills.

Your backround

• Bachelor’s degree or equivalent with concentration in biological, physical, health, pharmacy or other related science and 5+ years of relevant GCP experience or 3+ years of relevant GCP with a M.S. or equivalent in a scientific or allied health field preferably within a Clinical Research Organization (CRO) or pharmaceutical company setting.

• 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 preferred.

• GxP (e.g., GLP, GMP, GPVP, GPP) knowledge in addition to advanced GCP knowledge preferred.

• 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’reon a mission to hire thevery bestand 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.