Quality Assurance Manager

Requisition Number: 973

Position Title: Manager, Quality Assurance

External Description:

SUMMARY:  Worldwide Clinical Trails is searching for a talented QA Audit Manager to work onsite at our San Antonio Phase 1 clinic This person will be responsible for QA GCP Audits, line management, and QA departmental responsibilities at Worldwide Clinical Trials Early Phase Services Phase I Clinic. Please highlight your Phase 1 GCP QA experience.

RESPONSIBILITIES:

Tasks may include but are not limited to:

• Hosts and supports Sponsor and Regulatory Inspections of the Early Phase Services Phase I Clinic.
• Performs QA audits (including clinical study, report, in process, document and vendor audits) in accordance with QA department procedures
• Responsible for the hiring, performance appraisal, performance management, training, and career development of a team of QA staff
• Actively seeks feedback and monitors the quality of team members’ work on an ongoing basis, through the review of appropriate documentation and observed audits.
• Ensures all team members comply with the Annual Audit Schedule including the completion of Audit Reports in an accurate and timely way and that all audit-related tracking records are completed.
• Escalates significant issues to Senior QA Management.
• Manages the resource aspects of the QA Audit team and contributes to operational reports
• Provides feedback of metrics to Senior Management on quality issues and audit /inspection outcomes
• Provides assurances that systems and processes are implemented to ensure that Clinical Trials are performed, and data are generated, in compliance with ICH-GCP and other applicable regulations.
• Actively participates in training sessions and workshops, including presenting reports from conferences attended.
• Ensures timely completion and documentation of all training requirements.
• Remains abreast of, and apply, updates to regulations, guidelines, and principles related to Good Clinical Practice (GCP) and advises on their use and compliance.
• Participates in bid defense meetings as required.
• May require travel up to 10%
• Performs 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.

OTHER SKILLS AND ABILITIES:

• Clear and concise writing skills
• Excellent oral communication skills
• Diplomatic interface skills with company and client personnel
• Meticulous, organized and methodical, with excellent attention to detail
• Experience working in a team environment under time and resource pressures
• Ability to lead and line manage a team, with experience in mentoring staff preferred
• Good computer literacy with working knowledge of PCs, Windows and Microsoft Office applications

REQUIREMENTS:

• Required: University bachelor’s degree in a biomedical or related life science, nursing or equivalent qualification
• Required: Proficiency in a variety of GCP audit types, obtained preferably from at least 4 years direct experience with GCP auditing, together with preferably at least 6 years of industrial (pharmaceutical, biotechnology, medical device, or CRO) or GCP experience
• Required: Phase I Clinic QA experience
• Preferred: Line management experience

City:

State: Texas

Employment Type: Regular

Community / Marketing Title: Quality Assurance Manager

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.