Manager, Quality Assurance - Austin, TX - Onsite

Requisition Number: 7057

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 over 3,000 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 the Quality Assurance Department does at Worldwide

The QA 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. The 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 the QA Manager does at Worldwide

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, and 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, and Sr. QA Auditor.

What you will do

Tasks may include but are not limited to:

• Consistently maintain a professional demeanor (both written and spoken communication) when engaging with sponsors, external vendors, and colleagues on behalf of WCT.
• 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.

What you bring to the position

• Sound knowledge of applicable GxP regulations and requirements as well as Worldwide Clinical Trials policies and procedures.
• Understanding of FDA Part 11 regulations and other international guidelines specifically addressing Computer Systems Electronic Record/Electronic Signature (ERES).
• 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.

Your experience          

• Must have a 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 personnel management experience
• Prefer a minimum of 5 years experience in regulatory affairs, auditing, clinical research, monitoring, laboratory, or other relevant area, of which 3 are in quality assurance auditing

 

City:

State:

Employment Type: Regular

Community / Marketing Title: Manager, Quality Assurance - Austin, TX - Onsite

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: Austin, 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.