GxP - Global Quality Systems Project Management/Reporting (Contract) 24853

Job Description

The Global Quality Systems Senior Specialist will be responsible for supporting the Global Quality Systems team with design and delivery of Quality system health reports, CAPA support, project coordination and administrative support for the various initiatives. This individual will also support the Global Quality systems team in development of training materials and documentation related to the various Global Quality systems continuous improvement projects as well as the Quality Risk Management strategic initiative.

 

 

*** The ideal candidate will have (Pharma) GxP project management experience, has supported quality systems, and experience reporting and presenting to cross-functional teams. ***

 

 

Key Duties and Responsibilities:

 

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

• Supports the Global Quality System team in the design and delivery of dashboards and reports to allow real-time assessment of quality system compliance and to enable data driven decision-making.
• Support the development of training documentation and job aids in support of the Global Quality Systems initiatives and Quality Risk Management strategy  
• Provide project coordination for continuous QMS / Global Quality System improvement projects and initiatives.
• Support the documentation and execution of CAPA action items associated with Global Quality systems.
• Provide administrative support to the Global Quality systems team.
• Update the Communication teams/SharePoint sites as needed to reflect current state.
• Other assigned activities as determined by Global Quality Systems team.

 

Knowledge and Skills:

 

• Strong knowledge of GxP regulations and concepts related to Quality Systems management.
• Experience working in a GxP regulated environment in Quality Systems, Compliance, Data Quality, Quality Operations roles.
• Experience with data visualization tools
• Well-versed in industry standards and best practices related to data analysis and reporting
• Ability to collaborate effectively with cross-functional teams.
• Strategic, critical and analytical thinking
• Strong oral and written communication skills to explain complex information to others
• Ability to identify and independently seek out needed information
• Detail oriented, with demonstrated ability to independently plan and conduct data analysis
• Experience in project management and working with PM software
• Experience with managing CAPAs in electronic Quality Management Systems
• Expertise in Microsoft suite (PowerPoint, Teams, Word, Excel, Outlook).

 

Education and Experience:

• Bachelor's degree in technology, engineering, life sciences or related field or equivalent, with 5+ years of relevant work experience, or the equivalent combination of education and experience. 
• Experience supporting Quality Management Systems across various GxPs
• Project management certification preferred.

 

 

 

Remote posting, assume 12-month contract

Pay Range

$55-$65/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, competencies, experience, location and/or being pursued and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements

 

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