Quality Assurance III

Top required skills, experience or education

This individual will work in the Global Quality System & Strategic Transformation organization supporting global projects and initiatives related to Quality Risk Management. Activities include all aspects of project management such as leading global projects, creation of deliverables, working with stakeholders and driving technical enhancements. The individual will directly work with the Global Quality Risk Management team and be responsible for assessing regulations, developing governance, executing risk documents, and maintaining records.

This role involves active collaboration with a cross-functional team in manufacturing sites, manufacturing, scientists, supply chain, quality, and other global functions. This global function includes monitoring, tracking, and supporting various efforts and initiatives in the Quality System.

• Lead meetings to facilitate and/or support the QRM projects.
• Actively collaborate with a cross-functional team to complete project milestones per established timeline.
• Assist the functional areas on completing the milestones, as needed.
• QA review of the governance or risk document content in compliance with established governing documents.
• Oversee, monitor and track key deliverables associated with project implementation and metrics.

• Bachelor’s degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering, or other technical/scientific area.
• Minimum of 5 years of experience in Quality Assurance and/or Quality System oversight. Quality Risk Management, Compliance, and supply chain experience required.
• Project Management experience required.
• Highly motivated and confident facilitating meeting with people from different levels including executives and scientific / technical experts.
• Experience interpreting regulatory documents such as ICH, US / EU and other key GMP regulations to develop risk management governance such as impurities risk assessment, shortage prevention planning, etc.
• Experience working with changes to process or document control and familiar with Track Wise, and Veeva.
• Skills:
  
  Result-oriented, strong oral and written communication skills, excellent interpersonal skills, self-starter, attention to details, time management in a fast-paced environment, teamwork, and problem solving. Experience with metrics, visualizations for executives / concise & relevant message, and data analytics. Experience with automation and developing IT solutions.
• Computer system skills including:
  Advanced or intermediate skills with Microsoft Office suite (e.g. Word, Visio, Power point, Excel, Power
  
  BI, Teams, SharePoint, etc.), Track Wise, and Veeva.

“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”