Quality Systems Project Manager (Contract) 00000

Vertex Pharmaceuticals is seeking a Quality Systems Project Manager to support the Quality Risk Management process. This role involves project coordination on strategic initiatives and oversight activities to ensure compliance with regulatory requirements and industry standards.

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

Requirements:

• Extensive experience in Risk Management, Quality Systems and Project Management in a pharmaceutical environment
• 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)
• 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
• Experience with lean six sigma, Risk assessment tools and DMAIC concepts