Associate Director, QA Audits & Inspections Program

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 over 3,500+ 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.

Why Worldwide

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!

• S**UMMARY: The Associate Director of QA Audits and Inspections Program is responsible for contributing to the strategic vision, oversight, planning, execution, reporting and quality management of the QA Audits & Inspections Program. This position supports hosting and management of external audits of Worldwide. * *RESPONSIBILITIES:* Champions and adheres to Worldwide’s Quality Management System (QMS) Serves as a positive ambassador of the QA organization with internal and external customers Participates in the crafting of the QA organizational goals and objectives as assigned Ensures adherence to budgets per Worldwide processes. Mentors a team of Quality professionals and ensures quality deliverables, on time, and in compliance with regulations and Worldwide processes for all Audit & Inspection activities Oversees, monitors, and reports for internal and external QA audits to ensure timely completion of applicable CAPAs to prevent reoccurrence and to drive process improvements Develops and drives continuous process improvements Participates in the development and review of Quality Management Documents Assists with tracking and reporting of Key Quality Indications (KQI) and Quality Tolerance Limits (QTL) for the Audit & Inspection Program Assists with performance of QA audits for Vendors, Internal Process, Clinical Investigator, Document and other audits as assigned. Manages, plans, hosts, reports, documentation and follow up of all Worldwide Sponsor audits Serves as a core member on the Global Regulatory Inspection Team for all Regulatory Inspections of Worldwide Provides support to Sponsors Inspections in relation to Worldwide provided services Assists with lessons learned opportunities following inspections to allow for transfer of knowledge and training Ensures data and record management in accordance with the QMS Assists in developing training material and/or delivers training related to Audits and Inspections Serves as a Subject Matter Expert on QA Quality Management processes for Audits and Inspections Communicates relevant regulatory intelligence that has impact on the QMS to the QA team 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: * Ability to work with minimal supervision and guidance Demonstrates excellent organizational leadership competencies, inclusive of scheduling and leading team meetings that are effective, efficient, and documented Demonstrates excellent decision-making skills Demonstrates excellent ability to effectively communicate and influence the outcomes of decision-making process Communicates professionally, concisely, clearly, and consistently to external and internal customers both verbally and in writing Acts with authority to drive performance and accountability Demonstrates excellent skillset for influencing, being resourceful, managing conflict and negotiating Demonstrates an excellent 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 Demonstrates an excellent understanding of clinical research principles and processes for clinical trials Demonstrates ability to work collaboratively with cross functional stakeholders to drive process improvements based on Quality Indicators Demonstrates the ability to implement risk management strategies *REQUIREMENTS:* Possesses broad expertise related to understanding the principles and application of quality and regulatory compliance related to GxP activities Excellent understanding of the principles for a GCP Quality Management System Excellent working knowledge of ICH Guidelines, FDA regulations, European Directives, MHRA Statutory Instruments, and AIFA CRO Decree Possesses broad experience related to understanding the principles and application of quality and regulatory compliance related to GxP activities, specifically GCP knowledge Previous experience with participating in one or more of the following regulatory inspections: FDA GCP inspections, MHRA GCP inspections, Health Canada GCP inspections, EMA GCP inspections, or other international Regulatory inspections Excellent experience in conducting QA Audits, specifically GCP for each type (i.e. Clinical Investigator Audits, Vendor Audits, Internal Process Audits, For-cause Audits, Document Audits, etc.) Excellent understanding of risk-based approaches to auditing Demonstrated experience for leading Sponsor Audits independently Excellent understanding of the Drug Development Process Ability to speak, read and write English fluently Bachelor’s degree with concentration in nursing, biological, physical, health, pharmacy or other related science and 8+ years of relevant GCP experience; or equivalent work experience. Experience with Microsoft based applications, including proficiency in Excel, Word, Trackwise, SharePoint, and PowerPoint Domestic and limited international travel, as required Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently.
  
  

We love knowing that someone is going to have a better life because of the work we do.

To view our other roles, check out our careers page at Discover a world of difference at Worldwide! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.

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 know that when our employees feel appreciated and included, they can be more creative, innovative, and successful. We’re on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. 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.