Quality Assurance Information Systems Management, Senior Manager

Job Description

The Information Systems Management Senior Manager helps develop and implement validation strategies for complex technologies and systems to ensure compliant system life cycles management. This role supports periodic review, audit and inspection support for a wide range of Information Technologies including Cloud Systems and Vertex hosted information systems. The role also entails deep and broad understanding of GxP regulations including those that apply within the medical devices and cell and gene therapy areas.

Key Responsibilities:

•Use effective communication skills (verbal and written) to influence and align cross-functional team members, peers and superiors.

•Fosters collaboration and builds partnerships to integrate Quality activities with other functions.

•Provide leadership to the cross functional project teams to define test strategies and test manuals for tracking and fixing software issues.

•Conduct risk assessments within various GxP spaces, including medical devices and cell and gene therapy areas.

•Communicate and participate in defining best practices.

•Conduct qualification audits of automation / software providers.

•Develop remediation / mitigation strategies for service providers to ensure appropriate compliance.

•Independently manage and lead projects/teams of significant scope and complexity, while meeting all deliverables and timelines

•Help craft department goals and ensure linkage to individual goals

•May conduct presentations on quality issues and initiatives at cross functional meetings

•Where applicable, coach and mentor direct reports to ensure their continuous development.

•Develops, implements, and oversees quality activities in support of GxP Quality. These activities include, but not limited to the following:

Minimum Qualifications

•In-depth experience working in a regulated environment such as FDA, EU, MHRA

•Broad knowledge of data integrity related governing regulations.

•Proven experience in leading and managing complex technology projects and teams to meet corporate objectives and timelines.

•Deep understanding of the principles and application of quality and regulatory compliance with key focus on 21CFR Part11 requirements and equivalent regulations

•Contemporary knowledge of current industry trends, standards and methodologies as it relates to computerized systems and automated systems.

•Strong aptitude for facilitating group or project team endeavors.

•Ability to effectively communicate and influence the outcomes of the decision making process

•Hands-on experience of leading compliance oversight for complex technology implementation programs.

•Demonstrated experience of developing complex risk and compliance frameworks for different stages of product life cycle.

•Experience in the application of global regulations and requirements for electronic data integrity (21CFR Part 11, Annex 11, GAMP)

•In-depth experience with providing compliance oversight to implementation of variety of information technologies including SaaS, IaaS and other types of cloud systems, remote to internally hosted systems.

•Strong understanding the overall business processes and underlying data life cycle activities.

•Proficient with MS office applications including MS visio.

•Deep understanding of diverse set of GxP regulations and how these regulations can be leveraged to ensure overall data integrity

•Thorough and comprehensive understanding of a diverse set of technologies including SaaS, IaaS types of Information Technology Systems, Analytical Instruments Control / Computer Systems and SCADA (Supervisory Control and Data Acquisition) Systems.

Education and Experience:

•Bachelor's Degree in a scientific or computer sciences

Preferred Qualifications: 

•ASQ Auditor certification

•Lean Sigma 6 or equivalent certification

•Project Management skills certification

Hybrid-Eligible Roles

In this Hybrid-Eligible role, you can choose to be designated as: 

Hybrid: work remotely up to two days per week; or select On-Site: work five days per week on-site with ad hoc flexibility.

#LI-Hybrid #LI-AR1

Flex Designation:

Hybrid-Eligible Or On-Site Eligible

Flex Eligibility Status:

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at [email protected]