Quality Assurance - QMS Risk Management

To Discuss more about this job opportunity, please reach out to Deepak Arya (LinkedIn URL - www.linkedin.com/in/deepak-arya-8a79aa22a/), email your updated resume at Email - deepak.arya@collabera.com. Thank you! Pay Range: $40 to $45 an hour. Client Industry: Pharmaceutical Job Mode: Onsite Contract Duration: 08 Months (possibilities of Extension) Description: This role supports global quality initiatives focused on Quality Risk Management (QRM) and quality system governance. The position is responsible for leading projects, coordinating cross-functional stakeholders, and ensuring quality risk documentation and governance activities are executed in compliance with regulatory standards. The role works closely with global quality teams, manufacturing, supply chain, and scientific stakeholders to drive improvements in quality processes and risk management frameworks. The individual will also support data analytics, reporting, and digital initiatives related to quality systems. Must Haves: • Bachelor’s degree in a scientific or technical field such as Biology, Chemistry, Microbiology, Pharmacy, or Engineering • Minimum 5 years of experience in Quality Assurance or Quality Systems oversight • Experience with Quality Risk Management, regulatory compliance, and governance documentation • Experience interpreting global regulatory guidelines including GMP and ICH related documentation • Project Management experience managing cross-functional initiatives • Experience with document control or process change management • Familiarity with TrackWise and Veeva quality systems • Strong skills in • • Office tools including Excel, Word, PowerPoint, Visio, PowerBI, Teams, and SharePoint • Experience with data analytics, metrics tracking, and executive-level reporting • Ability to facilitate meetings and collaborate with stakeholders across technical and leadership levels • Ability to manage multiple projects independently in a fast-paced environment Day to Day: • Lead meetings to support Quality Risk Management initiatives and project activities • Collaborate with cross-functional stakeholders including manufacturing, quality, supply chain, and scientific teams • Track and manage project milestones to ensure timely delivery of quality system initiatives • Support development and review of governance documentation and risk management documents • Conduct quality assurance review of risk assessments and governance documentation for compliance • Monitor project progress and maintain records for quality system initiatives • Develop and track metrics and dashboards to communicate project performance and quality trends • Support data analytics, reporting, and visualization for leadership decision-making • Assist teams with project deliverables and milestone completion • Support digital and automation initiatives related to quality systems and risk management Plusses: • Experience developing digital tools or automation solutions for quality processes • Experience with data visualization tools and executive dashboards • Prior experience supporting global quality transformation initiatives • Exposure to pharmaceutical or life sciences manufacturing environments Benefits: The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, (paid time , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually - AS Applicable)