Good Clinical Practice Quality Director - Gaithersburg, United States - AstraZeneca

AstraZeneca

Verified Company

Gaithersburg, United States

3 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

Are you ready to be part of the future of healthcare? Are you able to think big, be bold and harness the power of digital and AI to tackle longstanding life sciences challenges? Then Evinova, a new healthtech business part of the AstraZeneca Group might be for you

Transform billions of patients' lives through technology, data and cutting-edge ways of working. You're innovative, decisive and transformative. Someone who's excited to use technology to improve patients' health. We're building a new healthtech business - Evinova, a fully-owned subsidiary of AstraZeneca Group.

Evinova delivers market-leading digital health solutions that are science-based, evidence-led, and human experience-driven. Thoughtful risks and quick decisions come together to accelerate innovation across the life sciences sector.

Be part of a diverse team that pushes the boundaries of science by digitally empowering a deeper understanding of the patients we're helping.

Launch pioneering digital solutions that improve the patients' experience and deliver better health outcomes.

The Good Clinical Practice (GCP) Senior Quality Manager will be responsible for ensuring that Evinova clinical trial solutions are developed, implemented and operationally supported in accordance with relevant global regulations including ICH and FDA guidelines.

The expectations of the role will expand with the maturity of the Evinova business with a clear focus on delivering high quality, compliant products and services with industry-leading, highly-automated and efficient practices.

This includes active participation in external industry forums, consultation and engagement with regulators, and collaboration with customers pre and post-sales.

The role will represent the company in vendor qualification, routine audits, and health authority inspections where applicable.

This role presents an opportunity to join Evinova from the beginning, designing and implementing new, innovative approaches to Quality and Compliance that are designed by industry, for industry with the following responsibilities:

Provide GCP oversight and support to the development, implementation, continuous improvement, and maintenance of the Evinova Quality Management System that meets the requirements of the GxP, GCP, GmP, FDA's QSR, MDD, ISO 13485 and other standards as required
Provide Good Clinical Practice (GCP) oversight and support the development, implementation, continuous improvement of the Evinova Quality Management System that meets the requirements of the GxP, GcP, GmP, FDA's QSR, MDD, ISO 13485 and other standards as required
Guide, support and validate Evinova software implementation, operations and support practices and teams in accordance with GCP guidelines
Perform training and education internally in global GCP standards, and externally as required (Investigator Meetings, CRA Trainings, Pre-Approval Inspections, etc.)
Work with the internal audit system group to ensure continued compliance to domestic and international regulatory regulations
Work closely with the company's Quality, Audit and Operations teams to ensure local procedures and performance are consistent with company's GCP quality objectives
Promote and enforces compliance with established quality systems, operating procedures and proactively manages change as external regulations and standard methodologies emerge
Oversee the operational implementation of leadership decisions and ensures alignment with desired outcomes in relation to Evinova's Quality and Compliance strategy specifically in relation to GCP
Embrace a customercentric, hardworking, right problem / right solution engineering approach and culture.
Manage and balances legal risk by understanding current and emerging industry regulations and taking proactive action to modify internal quality and compliance policies and procedures
Continuously update knowledge by participating in educational opportunities, reading professional publications and participating in professional organizations
Actively participate in product strategy and roadmap development, ensuring quality and compliance requirements are represented and balanced with new capability development
Coordinate with study team and/or solution implementation teams members to ensure vendor audits are appropriately scoped and that thirdparty auditors are provided all the documentation and insights required for successful audit execution
Work with internal and external customers to develop and complete strategic plans to identify, mitigate, monitor, and report GCP study risks on a per study basis where required
Other duties as assigned

Minimum Qualifications:

Bachelor's Degree
A minimum of 10+ years of experience in the pharmaceutical industry
Strong knowledge of global GCP/GMP regulations, guidance, and standards
Experience in developing pharmaceutical or medical device Quality Systems in a regulated environment and generation of S