Manager, Quality Assurance (GCP / Early Phase) - $10k Sign On Bonus!

Requisition Number: 5071

Position Title: Manager, Quality Assurance

External Description:

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 almost 2,500 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.     

What you will do 

 SUMMARY: To have in-depth experience and working knowledge in appropriate GxP compliance and other applicable regulations in order to conduct various types of audits to assess Worldwide Clinical Trials processes and procedures, applicable regulations and Sponsor SOPs, when necessary. Provides guidance on regulatory compliance to internal clients. Provides direction and coordination of project activities related to assigned areas in liaison with QA management. Manages a group of professional audit specialists, provides direction, guidance coaching, training and motivation to internal staff and external associates.  The Manager, Quality Assurance (QA) works under the general supervision and guidance of the Senior (Sr.) Manager, QA, Director, QA or Sr. Director, QA and may directly supervise the Associate QA Auditor, QA Auditor, Sr. QA Auditor.

• Always representing WCT in a professional manner (verbal, written, and in appearance) when interacting with sponsors, volunteers, outside vendors, and fellow employees.
• Coordinates and performs audits and completes written reports for each audit assigned.
• Manages all audits for early phase/ Phase I clinical trials, assigns projects, and provides QA Management with current status
• Monitors regulatory agency and industry compliance standards and trends to assure an appropriate Company compliance program.
• Identify improvements that enhance the quality and manages corrective and preventive action plans (CAPAs) to resolve potential quality issues
• Assists with training and mentoring of the audit team on GCP/GLP, SOP’s, and other related training

What you will bring to the role 

• Sound knowledge of GxP (specifically GCP) regulations and requirements
• Ability to coordinate multiple projects and have the flexibility needed to adjust to changing priorities and unforeseen events.
• Ability to use logical inferences to understand the “big picture” and long term implications of these issues.
• Understanding of FDA Part 11 regulations and other international guidelines specifically addressing Computer Systems Electronic Record/Electronic Signature (ERES).
• Ability to interact professionally, promote team work, and to work independently or in teams.

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 of 2 years of management experience
• Minimum 5 years’ experience in regulatory affairs, auditing, clinical research, monitoring, laboratory, or other relevant area, of which 3 are in quality assurance auditing.  

Why Worldwide  

At Worldwide, we balance fun with the serious business of changing lives. We have a values-driven culture that is built from the ground up. We empower our team members to treat every clinical trial like a patient’s life depends on it – because it does. Our leaders are in the trenches with you - committed to advancing science and moving mountains for our customers.    

Interested in hearing more about Worldwide or our roles? Check out our careers page at www.worldwide.com/careers! 

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City:

State: Texas

Employment Type: Regular

Community / Marketing Title: Manager, Quality Assurance (GCP / Early Phase) - $10k Sign On Bonus!

Company Profile:

We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.

Location_formattedLocationLong: San Antonio, Texas US

CountryEEOText_Description: 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 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. Worldwide is committed to working with and providing reasonable accommodations to applicants with disabilities. We are proud to be an equal opportunity workplace where people thrive by being themselves and are inspired to do their best work every day.