Vice President QA Early Phase Services

Requisition Number: 1128

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 GLP, GcLP, and GCP Quality Systems. This position will be located in Austin, TX, or San Antonio, Texas and reports directly to the EVP Global Head of Quality.

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
• Establish global quality strategies and goals to ensure GxP compliance and realization of other value-added Quality Management Documents and best practices
• Serves on the Early Phase Services (EPS) and QA Leadership Teams and participates in QMS Governance Committees as assigned
• 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 GxP 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
• Approves work-related travel and expenses reports for direct reports while staying on budget and in compliance with Worldwide Travel Policy

EPS Audit and Inspections

• Establishes oversees and executes the EPS compliance and auditing program to monitor compliance with GxP international regulations and Worldwide procedures
• Provide 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
• 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

SKILLS AND ABILITIES:

• Demonstrated advanced organizational leadership competences
• Demonstrated ability for driving results and role modeling as a cross-functional collaborator
• Demonstrated ability to effectively communicate, escalate, and influence the outcomes of decision-making process
• Demonstrated advanced project management and decision-making skills
• Communicates professionally, concisely, clearly and consistently to external and internal customers both verbally and in writing
• Demonstrated ability to think critically and lead calmly in complex situations, with strong decision-making skillset
• Ability to lead a team of individuals with a clear vision and defined purpose to drive performance and accountability
• Demonstrated skills for influencing, being resourceful, managing conflict and negotiating
• Demonstrates an advanced aptitude for facilitating group or project initiatives and building team unity
• Works with a sense of urgency; ability to recognize time sensitivity and leads assertively
• Previous experience with leading/participating in FDA BIMO inspections, MHRA GCP inspections, Health Canada GCP inspections, EMA GCP inspections, and other international Regulatory inspections is an asset

REQUIREMENTS:

• Possesses broad expertise related to understanding the principles and application of quality and regulatory compliance related to GLP, GcLP and GCP activities
• Advanced understanding of the principles for a GxP Quality Management System
• Advanced working knowledge of ICH Guidelines, FDA regulations, Health Canada regulations, European Directives and Regulations
• Understanding of 21 CFR Part 11 regulations and other international guidelines specifically addressing Computer Systems Electronic Record/Electronic Signature
• 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
• Ability to speak, read and write English fluently
• Bachelor’s degree in nursing, biological, physical, health, pharmacy or other related science; advanced degree in a scientific or allied health field preferred
• Minimum 10 years of relevant GxP experience; experience working in a bioanalytical laboratory is preferred
• Minimum 4 years of managerial experience with direct oversight of a team
• Highly proficient with Microsoft based applications, including Excel, Word, SharePoint, and PowerPoint.

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.