nference - QA & Release Manager - Change Control

At nFerence, we at looking someone to QA & Release Manager to lead the process of Change Control, evolve change control practices and change control documentation while ensuring compliance to applicable standards and regulations (i.e., SOC2, HITRUST, ISO 13485, 21 CFR820, 21CFR11). Improve and influence cross-functional change control processes. The role will ensure compliant change control processes are implemented and aligned globally and develop and lead the Change Control Board process.

Roles & Responsibilities:

Manage Change Control Function.

Keep processes up to date with current practices; responsibility for all change control and documentation procedures/processes and update them in accordance with company growth and change. Collaborate with different department managers to ensure integrity of changes and process improvements.

Facilitate change control board review of impact of changes and review and approval of changes.

Ensure change control processes include assessment, impact, review, approval, and implementation of all changes requested.

Ensure all changes are reviewed/approved by appropriate staff.

Ensure changes are effectively communicated to impacted functions.

Ensures that all change actions are completed as prescribed per the change scope.

Provides hands-on guidance and training to all personnel performing activities within the applicable quality system.

Works with Change owners to progress robust changes through the system.

Provides guidance to team leaders and approvers and reviews all changes to ensure documentation is complete before submission to the Change Control Review Board.

Communicate the status of open items to management as needed.

Makes effective written and verbal presentations, as needed.

Participates in the development and/or revision of Quality system SOPs. Prepares and distributes monthly and quarterly metrics reports (written and graphic) to management regarding the status of changes and their sources and participates in the development of quality performance measures.

Performs other related duties, as assigned.

Demonstrates knowledge of Risk Programs

Demonstrated ability to influence, organize and motivate cross-functional teams at all levels in the organization to meet quality and compliance goals.

Ability to analyze complex problems and apply practical solutions.

Ability to communicate clearly and concisely within a diverse environment.

Must be able to work independently with minimal supervision and be self-driven.

Able to prioritize projects and manage resources to meet organizational goals and objectives.

Able to understand domestic and international regulations, as well as internal operating procedures, their importance and adhere to them.

Agile or other relevant change control software knowledge is a plus.

Support the Quality Systems Department with internal and external audit processes.

Facilitate the access to internal documentation.

SME for presenting to auditors the Document and Data control system established through Agile or electronic document management system.

Support audit back room during internal or external audits and inspections as necessary.

Support the Quality Systems Department with other responsibilities related to Change Control and Document Control.

Desired Skills:

Minimum 5+ years of previous experience working in Change Control within a Quality Management System in the Medical device or pharmaceutical industry

Experience in establishing and maintaining a change control process including developing change implementation plans, determining change control requirements, and ensuring all changes are implemented in a manner to control risk to the organization

Minimum Bachelor's Degree in a Technical or Science field

Experience with an electronic documentation system

Experience in writing Agile or electronic document management system training

Competent using Word/Docs, Excel/Sheets, and Gmail/Outlook.

Experience with JIRA required

Experience with Confluence required

Experience with Greenlight Guru a plus

Experience with LucidChart a plus

Ability to work with multiple departments and locations to resolve issues

Well-developed written and verbal communication skills

Ability to work independently with minimal supervision

Detail oriented and organized

Why should you join us?

Work with some of the brilliant minds of the world solving exciting real world problems through Artificial Intelligence, Machine Learning, analytics and insights through triangulating unstructured and structured information from the biomedical literature as well as from large scale molecular and real world datasets.

Our benefits package includes the best of what leading organizations provide, such as stock options, paid time off, healthcare insurance, gym/broadband reimbursement.