Manager, Quality Assurance - Austin, TX - Onsite
Location: Austin, TX, USA
Requisition Number: 7057
Position Title: Manager, Quality Assurance
Who we are
Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality. Anchored in our company’s scientific heritage, our dedicated therapeutic focus on cardiovascular, metabolic, neuroscience, oncology, and rare diseases, is applied to develop flexible plans and solve problems quickly for our customers.
Our talented team of 3,000+ professionals spans 60+ countries. We are united in cause with our customers to improve the lives of patients through new and innovative therapies.
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 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, 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.
- Monitors regulatory agency and industry compliance standards and trends to ensure 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.
- Fosters a good working relationship with internal clients and QA team.
- Identifies areas for process improvement and provides this information to management.
- Manages and assigns corrective and preventive action plans (CAPAs) to ensure 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.
- Provide advice and guidance on regulatory requirements and SOPs.
- Assists with the selection, development, and evaluation of Quality Assurance Unit (QAU) personnel to ensure the efficient operation of the function.
- Assists with training and mentoring of the audit team.
- Assists with creating and presenting GCP/GLP and other related training sessions.
- Assists QA Management with review of Worldwide Clinical Trials policies and procedures and assists with the SOP Committee.
- Oversees the maintenance of records for each audit.
- Minimal travel may be required.
- Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
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.
- Ability to interact professionally and to work independently or in teams.
- Ability to prioritize work and define steps needed to achieve assigned project goals.
- Ability to speak, read, and write English fluently.
- Working knowledge of Microsoft Word applications and the ability to learn internal computer systems as necessary.
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
Minimum 5 years’ experience in regulatory affairs, auditing, clinical research, monitoring, laboratory, or other relevant area, of which 3 are in quality assurance auditing
Employment Type: Regular
Community / Marketing Title: Manager, Quality Assurance - Austin, TX - Onsite
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.