Senior/Executive Director, EP Quality

Location: San Antonio, TX, USA

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Requisition Number: 5065

Position Title: Executive Director QA Early Phase

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 almost 2,500 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 Senior Director/Executive Director QA Early Phase does at Worldwide

This role is responsible for partnering with the business unit leadership team to provide the quality oversight of Worldwide’s Phase I Clinic, Bioanalytical and Central Laboratories. This candidate is responsible for the strategy and QMS implementation, leadership of the Early Phase Quality Assurance (QA)team, providing assurance for compliance with applicable GxP regulations, laws, and guidelines. Role reports to EVP Global Quality.

What you will do

Strategy and Leadership

  • Develop and maintains high performing quality organization aligned with business goals 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
  • Serves on the Early Phase Services (EPS) and QA Leadership Teams and participates in QMS Governance Committees as assigned
  • Provide expertise and guidance in GxP matters

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 quality professionals including objective setting, performance management, coaching, training, development, and recruiting

EPS Audit and Inspections

  • Oversees and executes the EPS audit program for internal system/in-process audits and sponsor related study audits.
  • Provides oversight and resource for Worldwide external vendors’ quality programs as required, including CROs, central laboratories, investigator sites, and other key partners supporting clinical programs, including maintenance of quality agreements
  • Host and manages Sponsor audits and regulatory inspections

Quality Management System, and Process Development/Improvement

  • 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 and is a member of the Quality Management council
  • 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

What you will bring to the role

  • 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
  • Demonstrates an 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

Your experience

  • Bachelor’s degree in nursing, biological, physical, health, pharmacy, or other related science;
  • Minimum 12 years of relevant GxP experience which should include extensive GCP experience; experience working in a bioanalytical laboratory and Phase I unit is preferred
  • Minimum 4years of managerial experience with direct oversight of a team
  • Highly proficient with Microsoft based applications, including Excel, Word, SharePoint, and PowerPoint.
  • Broad expertise related to understanding the principles and application of quality and regulatory compliance related to GCP, GLP and GCLP activities
  • Advanced understanding of the principles for a GxP Quality Management System
  • Strong 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
  • Extensive auditing experience across range of clinical audit types, such as CROs, vendors, clinical investigator sites, protocols, clinical study reports, systems, and submissions

Why Worldwide

At Worldwide, we balance fun with the serious business of changing lives. We have a values-driven culture that is built from the ground up. We empower our team members to treat every clinical trial like a patient’s life depends on it – because it does. Our leaders are in the trenches with you - committed to advancing science and moving mountains for our customers. 

Interested in hearing more about Worldwide or our roles? Check out our careers page at www.worldwide.com/careers!

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City:

State: Texas

Employment Type: Regular

Community / Marketing Title: Senior/Executive Director, EP Quality

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.

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We only accept resumes from staffing organizations with pre-approved contractual agreements. Please do not forward resumes directly to our hiring managers, jobs alias, or any other company location. Unsolicited resumes from employment agencies will not be considered and Worldwide is not responsible for any fees related to unsolicited resumes.