Associate Director, QA Audits & Inspections Program - US - Remote

Worldwide Clinical Trials Holdings, Inc.; North Carolina; Hybrid; USD 80,000 - 120,000; Full time

Job summary

An established industry player is seeking an Associate Director for the QA Audits & Inspections Program. This remote role involves leading a dedicated team, ensuring compliance with quality standards, and driving process improvements. The ideal candidate will have extensive experience in GCP audits and regulatory inspections, showcasing strong leadership and decision-making skills. Join a passionate team committed to making a difference in healthcare, where innovation and quality intersect. This is an exciting opportunity to shape the future of clinical trials in a supportive and inclusive environment.

Qualifications

• 8+ years of relevant GCP experience required.
• Excellent experience in conducting QA Audits.
• Broad experience in quality and regulatory compliance.

Responsibilities

• Mentors a team of Quality professionals.
• Oversees internal and external QA audits.
• Develops and drives continuous process improvements.

Skills

GCP Audits

Quality Management System (QMS)

Regulatory Compliance

Decision-Making Skills

Communication Skills

Clinical Research Principles

Education

Bachelor's degree in Nursing or Related Science

Job description

Associate Director, QA Audits & Inspections Program - US/Canada - Remote page is loaded

Associate Director, QA Audits & Inspections Program - US/Canada - Remote

Apply remote type Remote locations Virtual United States North Carolina Virtual Canada Ontario time type Full time posted on Posted Yesterday job requisition id JR100920

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 and adheres to Worldwide’s Quality Management System (QMS) .

• Participates in the crafting of the QA organizational goals and objectives as assigned .

• Mentors a team of Quality professionals and ensures quality deliverables, on time, and in compliance with regulations and Worldwide processes for all Audit & Inspection activities .

• Oversees, monitors, and reports for internal and external QA audits to ensure timely completion of applicable CAPAs to prevent reoccurrence and to drive process improvements .

• Develops and drives continuous process improvements .

• Participates in the development and review of Quality Management Documents .

• Assists with tracking and reporting of Key Quality Indications (KQI) and Quality Tolerance Limits (QTL) for the Audit & Inspection Program .

• Assists with performance of QA audits for Vendors, Internal Process, Clinical Investigator, Document and other audits as assigned.

• Manages, plans, hosts, reports, documentation and follow up of all Worldwide Sponsor audits .

• Serves as a core member on the Global Regulatory Inspection Team for all Regulatory Inspections of Worldwide .

• Provides support to Sponsors Inspections in relation to Worldwide provided services .

• Serves as a Subject Matter Expert on QA Quality Management processes for Audits and Inspections .

What you will bring to the role

• A bility to work with minimal supervision and guidance .

• Demonstrates excellent organizational leadership competencies, inclusive of scheduling and leading team meetings that are effective, efficient, and documented .

• Demonstrates excellent decision-making skills .

• Demonstrates excellent ability to effectively communicate and influence the outcomes of decision-making process .

• Communicates professionally, concisely, clearly, and consistently to external and internal customers both verbally and in writing .

• Demonstrates an excellent understanding of clinical research principles and processes for clinical trials.

• Demonstrates ability to work collaboratively with cross functional stakeholders to drive process improvements based on Quality Indicators.

Your experience

• Bachelor’s degree with concentration in nursing, biological, physical, health, pharmacy or other related science and 8+ years of relevant GCP experience; or equivalent work experience.

• Excellent experience in conducting QA Audits, specifically GCP for each type ( i.e. Clinical Investigator Audits, Vendor Audits, Internal Process Audits, For-cause Audits, Document Audits, etc.).

• Previous experience with participating in one or more of the following regulatory inspections: FDA GCP inspections, MHRA GCP inspections, Health Canada GCP inspections, EMA GCP inspections, or other international Regulatory inspections.

• Possesses broad experience related to understanding the principles and application of quality and regulatory compliance related to GxP activities, specifically GCP knowledge.

• Excellent understanding of risk-based approaches to auditing.

• Demonstrated experience for leading Sponsor Audits independently.

• Domestic and limited international travel, as required.

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.

About Us

This is who we are.

We’re a team of clinicians, scientists, and researchers who want to make healthcare better. We were founded on an unwavering commitment to authentic, personalized attention. And today, as CROs consolidate and the industry changes rapidly, that personalized attention is more important than ever.

We all came to this industry for different reasons, from different walks of life. If you ask any one of us why we’re here, you’ll get a different answer. And that’s what makes us special.

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