Quality Systems Project Manager
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Job Description
Quality Systems Project Manager supporting Quality Risk Management processes in a pharmaceutical environment. Ensuring compliance and driving strategic initiatives with project coordination.
Responsibilities:
- Support the Quality Risk Management Quality System owner for project coordination on strategic initiatives
- Ensure compliance with regulatory requirements, industry standards and company policies
- Analyze QMS trends and KPIs to identify opportunities for continuous improvement
- Support the Quality system owner in compliance related activities
- Own, track and/or facilitate the completion of CAPAs, inspection/audit commitments, etc.
- Assist in authoring and revising SOPs, work instructions, and training materials
- Provide administrative support to the Global Quality systems team
- Collaborate with cross-functional teams to ensure timely and compliant execution of Quality Risk management activities
Requirements:
- Bachelor's degree in technology, engineering, life sciences or related field or equivalent
- 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
- 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
- Expertise in Microsoft suite (PowerPoint, Teams, Word, Excel, Outlook).
Benefits:
- Compensation, medical benefits, fringe benefits
- Overtime pay, in accordance with federal and state requirements
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