Quality Systems Project Manager

Job not on LinkedIn

🕒 May 15

🇺🇸 United States – Remote

💵 $65 - $70 / hour

⏳ Contract/Temporary

🟡 Mid-level

🟠 Senior

👷‍♀️ Project Manager

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Vertex Pharmaceuticals

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1989

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Vertex Pharmaceuticals is a global biotechnology company focused on creating transformative medicines for people with serious diseases. With a commitment to scientific innovation, Vertex engages in the discovery, development, and production of cutting-edge therapies, particularly for conditions such as cystic fibrosis, sickle cell disease, and pain management. The company also emphasizes corporate responsibility and diversity within its inclusive culture to drive innovation and improve patient lives.

📋 Description

• 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