Quality Management Systems, Senior Manager (Contract) 26440

Job Description

The Sr. Manger GPOC QMS will support activities related to the governance of GPOC processes and quality systems which will enhance efficiency and ensure standardized best practices within the GPOC team.

 

This role focuses on supporting the GPOC managed Process Owners Networks (PONs); Event and CAPA Quality Management, Training and Personnel Management, and Documentation and Control. This includes operational support and documentation, metrics evaluation and action item follow-up. This role will also manages the Global Quality System and Compliance (GQSC) Review Board to generate coming due, overdue and extended records related to the impacted quality system metrics.  

 

The role will also support the Veeva Vault Quality (QMS & DMS) platform with business portfolio management and the establishment of a new governance forum.  

 

This position reports directly to the Director, Quality Stnds, Training, & Improvements – Process Excellence.

 

Key Responsibilities:

The responsibilities of this position may include, but are not limited to, the following:

• Metrics generation and review including managing the bi-weekly Global Quality System Compliance (GQSC) Review board for tracking overdue, coming due and extended Deviations, CAPA, Effectiveness Checks, Trainings, and Biennial Reviews Documents for the GQSC team. Planned expansion to overdue risks and regulatory surveillance assessments will be developed.
• Prepare presentation material to manager forums (GPOC, GQSC) for additional follow up and reporting of the GQSC Review Board overdue records trending and response rate.
• General data analysis reporting to support requests for metrics from the Veeva QMS system, PowerBI or applicable dashboards. Partner with data analytics team on dashboard reporting, information visuals and improvements to data reporting
• Project Management support for the Event and CAPA Process Owners Network (PON) and the Document Control and Training PON including action item documentation, follow up and miscellaneous additional tasks as assigned.
• Manage PON operations including documentation of open risks, deviations, CAPAs, findings related to the GPOC owned PON (Event and CAPA, Training, Documentation).
• Business portfolio management for Veeva Quality Suite enhancements including documentation of platform roadmaps and enhancement release schedules.

 

Minimum qualifications:

 

Knowledge and Skills:

• Experience working in a regulated environment in Quality Systems, Compliance, Data Quality, Quality Operations roles with strong knowledge of GxP regulations
• Experience with project management concepts and skills for project planning, execution and follow up
• Experience with technology implementation in the GxP regulated environment
• Experience with concepts related to process excellence and continuous improvement skills
• Excellent verbal and written communication skills, including presentation and facilitation skills.
• Expertise in Microsoft suite (PowerPoint, Teams, Word, Excel, Outlook). Experience with other PM tools a plus (e.g. Microsoft Project, Asana, Smartsheet, ServiceNow etc.).
• Experience with electronic quality management systems (ex: Veeva preferred)
• Experience with data visualization tools (ex PowerBI preferred, advanced excel skills)
• Strong interpersonal skills to creatively facilitate communications among various groups and build alignment to achieve shared goals.
• Strong ability to work in a dynamic team environment, manage priorities, and maintain timelines for multiple projects.
• Strong problem solving and critical thinking skills, accompanied by Analytical thinking/Data Analysis skills

 

 

Education and Experience:

• Bachelor's degree in technology, engineering, life sciences or related field or equivalent, with 6+ years of relevant work experience, or the equivalent combination of education and experience.

Pay Range

$65-$70/hr

Requisition Disclaimer

This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (“Vertex”). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, com