Director, Quality Vendor and Digital Data - US/Canada - Remote

Worldwide Clinical Trials

7d•Remote

About The Position

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! What the Quality Assurance Department does at Worldwide The Quality Assurance department sets the bar high when it comes to quality. We are committed to exceeding the quality standards required by our sponsors, study participants, and regulatory authorities. Our QA culture is based on an environment where staff are trained, energized, and empowered to deliver high-quality products to our employees and customers.

Requirements

Demonstrated organizational leadership competencies.
Ability to lead a team of individuals with a clear vision and defined purpose.
Demonstrated ability for driving results and role modeling as a cross functional collaborator.
Strategic thinker, hands on, highly organized, detail oriented.
Demonstrated ability to effectively communicate, escalate, and influence the outcomes of decision-making process.
Has an advanced understanding of clinical research principles and processes for clinical trials.
Experience with identifying and implementing regulatory changes within life sciences organizations.
Previous experience with leading / participating in Regulatory Authority Inspections e.g.: FDA BIMO inspections, MHRA GCP inspections, Health Canada GCP inspections, EMA GCP inspections, or other international Regulatory inspections.
Bachelor’s degree or 4 year degree equivalent required; MS in a scientific or allied health field preferred.
Minimum of 12 years of relevant GxP experience.
Minimum of 4 years of management experience.
Experience of clinical, phase I and laboratory operations and systems.
Experience in Quality CSV OR: Knowledge of Clinical System Validation.
Advanced working knowledge of ICH Guidelines, FDA regulations, European Directives, UK Statutory Instruments.
Broad expertise related to understanding the GxP global requirements – regulations, laws and guidelines with the ability to identify key requirements and changes as they relate to Worldwide.
Understanding of 21 CFR Part 11 regulations and other international guidelines specifically addressing Computer Systems Electronic Record/Electronic Signature.
Domestic and international travel required (approximately 10-15%).

Responsibilities

Responsible for a risk-based Quality Vendor Oversight Program to ensure quality of deliverables and compliance to GxP regulations.
Establish GCP Vendor quality agreements and GMP quality technical agreements with key external customers.
Establish QA to QA meetings for key vendors.
Defining and monitoring quality tolerance limits for Vendors working in collaboration with the Vendor Management Team
Oversee the management of the QVD Audit Plan inclusive of vendors, depots, CSV, vendor, system, GMP and GDP audits/CAPAs.
Partner internally with key QA customers and operational internal stakeholders including to achieve Quality objectives.
Serve as a GCP/GxP subject matter expert for GMP, GDP, and GCP related services as applicable to Vendors and Systems.
Undertake GxP compliance oversight for new systems and operations championing a quality by design approach.
Identify and drive continuous improvement in GxP compliance for Worldwide Vendor and system processes activities.
Responsible for management and oversight of Vendor and system, quality issues, CAPA and Change control.
Support Worldwide inspections and Sponsor Audits as necessary.
Lead, mentor, and inspire a global team, fostering a collaborative and innovative environment.