Manager, Quality Assurance (Lab) - Austin - Office-based

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 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 

• Coordinates and performs audits and completes written reports for each audit assigned. 

• Manages and assigns the projects and audit status and provides QA Management with current status upon request. 

• Manages the Vendor Audit program and assigns audits as required. 

• Monitors regulatory agency and industry compliance standards and trends to assure an appropriate Company compliance program. 

• Coordinates and facilitates sponsor audits/regulatory inspections, as assigned. 

• Assists with review of audit reports to identify improvements that enhance the quality and clarity of the reports. 

• Manages and assigns corrective and preventive action plans (CAPAs) to assure follow-up and implementation of corrections for internal and external audits and liaisons with other departments to resolve potential quality issues to improve quality and efficiency. 

• Provides advice and guidance on regulatory requirements and SOPs. 

• Assists with training and mentoring of the audit team. 

• Assists with creating and presenting GCP/GLP and other related training sessions. 

• Oversees the maintenance of records for each audit. 

What you will bring to the role 

• Sound knowledge of applicable GLP/GxP regulations. 

• Ability to coordinate multiple projects and have the flexibility needed to adjust to changing priorities and unforeseen events. 

• Understanding of FDA Part 11 regulations and other international guidelines specifically addressing Computer Systems Electronic Record/Electronic Signature (ERES). 

Your experience 

• Bachelor’s degree or higher in life science or equivalent experience gained by working in a relevant area (clinical setting, laboratory, etc.). 

• Minimum 5 years’ experience in regulatory affairs, auditing, clinical research,