Vice President QA Early Phase Services

Requisition Number: 1990

Position Title: Vice President QA Early Phase Services

External Description:

SUMMARY:

The Vice President is responsible for the quality oversight of Worldwide’s Phase I Clinic, Bioanalytical, and Central Laboratories. This candidate is responsible for the strategy, implementation, and leadership of the Early Phase Quality Assurance (QA) function and is accountable for the execution and administration of the GCP and GLP Quality Systems.

RESPONSIBILITIES:

Strategy and Leadership

• Builds and develops a high performing quality organization and leads staff development in alignment with Worldwide’s strategic goals, quality objectives, and operational systems
• Serves as a positive ambassador of the QA organization, demonstrating a strong service mindset towards both internal stakeholders and external customers
• Acts as a champion for continuous improvement within the Worldwide Quality Management System (QMS) through a well-trained workforce, streamlined business processes and appropriated structured quality operations
• Provide expertise and guidance to EPS in interpreting and implementing governmental and agency guidelines to assure compliance

Early Phase Services QA Management

• Establishes, maintains, oversees and ensures effectiveness of quality programs and documentation for EPS (Phase I Clinic, Bioanalytical and Central Laboratories) to assure compliance with GCP international regulations and Worldwide procedures
• Develops short and long-term plans to achieve both quality and business objectives
• Leads a team of EPS quality professionals including objective setting, performance management, coaching, training, development, and recruiting
• Plans, adjust, manages, and optimizes all resources (budgets, staff and technologies) for the advancement of QA’s goals and objectives for EPS

EPS Audit and Inspections

• Establishes oversees and executes the EPS compliance and auditing program to monitor compliance with GCP international regulations and Worldwide procedures
• Provides QA oversight of external vendors’ quality programs, including CROs, central laboratories, investigator sites, and other key partners supporting clinical programs, including maintenance of quality agreements
• Responsible for the preparation and facilitation of EPS regulatory inspections

EPS Quality and Process Development

• Serves as a Subject Matter Expert (SME) and in-house advisor on GxP compliance for EPS
• Manages QA oversight of deviations, quality issues, CAPAs and product complaint investigations
• Assures that appropriate Quality Management Documents are in place and optimally maintained to support the critical drug development activities for EPS
• Ensures training and education are adequate and appropriately provided, including development and delivery of training materials as needed
• Defines and reports key quality and compliance metrics to proactively identify emerging trends to ensure continuous improvement and compliance
• Reports quality compliance activities and findings to Worldwide senior leaders on a regular basis

REQUIREMENTS:

• Minimum 10 years of relevant GCP experience
• Minimum 4 years of managerial experience with direct oversight of a team
• Direct experience with GLP or experience working in a bioanalytical laboratory is ideal
• Bachelor’s degree in nursing, biological, physical, health, pharmacy, or other related science; advanced degree in a scientific or allied health field preferred
• Advanced working knowledge of ICH Guidelines, FDA regulations, Health Canada regulations, European Directives and Regulations
• Background in overseeing quality for drug analyses in biological samples under GLP, BA/BE, ADME studies
• Extensive auditing experience across range of clinical audit types, such as CROs, vendors, clinical investigator sites, protocols, clinical study reports, systems, and submissions
• Proven experience in developing, managing, and complying with annual budgets

Regarding the Location of this Role:

• Ideal candidate is located in Central Texas (Greater Austin – Greater San Antonio Areas) or willing to relocate within an agreed upon timeframe upon acceptance
• Worldwide will also consider candidates who can commit to 50% travel which would need to be in two full workweek increments out of every month

City:

State: Texas

Employment Type: Regular

Community / Marketing Title: Vice President QA Early Phase Services

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.