Job Description

The Global Quality Systems “Manager” will be responsible for supporting the Quality Risk Management Quality System owner with the support needed for Quality Risk Management process. This includes providing project coordination on strategic initiatives and day-to-day oversight activities to ensure compliance with regulatory requirements, industry standards and company policies. This individual will also support the Quality system owner with management of goals and actions associated with the QRM strategic plan.

The ideal candidate will have extensive experience in Risk Managment, Quality Syestems and Project Managment in a pharmaceutical environment.

Key Duties and Responsibilities:

• Serve as primary support and project coordinator for the QRM processes and strategic initiatives, including continuous improvement of Quality Risk Management system
• Collaborates with cross-functional teams to ensure timely and compliant execution of Quality Risk management activities
• Supports the Quality system owner in compliance related activities; may own, track and /or facilitate the completion of CAPAs, inspection /audit commitments, etc.
• Analyzes QMS trends and KPIs to identify opportunities for continuous improvement
• Performs compliance and data quality checks as part of QRM quality system oversight to ensure execution is compliant with internal procedures / regulatory requirements
• Assist in authoring and revising SOPs, work instructions, and training materials
• Assist the process owner with managing the various continuous improvement initiatives and projects.
• Function as a Super User and help support the end users of QRM technology as needed.
• Provide administrative support to the Global Quality systems team.
• Performs other duties as assigned

Knowledge and Skills:

• Strong knowledge of GxP regulations and concepts related to Quality Systems management, specifically Quality Risk 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 risk assessment tools and technology

• 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 Risk Management across various GxPs
• Project management certification preferred
• Experience with lean six sigma, Risk assessment tools and DMAIC concepts

Pay Range

$65-$70/hr (75/hr for Sr. Manager level)

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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