Manager

Job Description

Purpose:

The Manager, R&D Quality Assurance & Data Integrity will serve as a liaison between key stakeholders to facilitate the implementation and continuous improvement of the R&D quality system by supporting key activities such as management review, issue escalation, quality agreememnts, and data integrity. They will be responsible for monitoring and reporting on trends, coordinating key project deliverables, and working cross functionally to drive implementation of risk mitigation activities.

Responsibilities:

Coordinate data integrity reviews and drive implementation of remediation activities.

Monitor and report on trends identified through routine surveillance of Quality intelligence.

Lead and/or assist with data integrity remediation activities including any potential validation or procedural updates required to address identified data integrity risks.

Maintain documentation suite associated with the R&D Data Integrity Strategy.

Lead and/or coordinate the development of guides, tools and resources to reinforce core quality concepts.

Support continuous improvement initiatives by driving updates to policies, procedures and training.

Liaise with key stakeholders to drive timelines and report on key deliverables.

Provide support for management review by coordinating the collection and reporting of key data from functional area reviews, creating and maintaining review templates, and working with the Quality System team to identify and implement improvements.

Support and/or lead investigations where there is a known or suspected impact to data integrity. Collaborate cross functionally to identify appropriate CAPA, and monitor/drive implementation.

Serve as a champion for data integrity by supporting leadership in raising awareness about data integrity, and their role in ensuring compliance. This includes creation and maintenance of training.

Support and/or conduct impact assessments on regulatory intelligence to identify required updates to the Data Integrity Strategy.