Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - To enable our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. As part of our clinical research portfolio, our CorEvitas evidence-based solutions specialize in generating data intelligence and clinical insights needed to bring safe and effective treatments to market. Your objectivity and dedication to patient safety will improve health outcomes that people and communities depend on - now and in the future.

• Collaborate with talented professionals across departments to promote a culture of quality excellence
• Build upon existing processes to establish, enhance, and improve quality assurance policies, procedures, and standards to ensure consistency and compliance across all research project operations
• Establish a mechanism to quantitatively assess compliance to these policies and procedures to promote excellence (KPIs)
• Conduct proactive internal audits and assessments to evaluate the effectiveness and adherence to quality systems and identify areas for improvement; Ensure timely follow-up on major and critical audit findings, ensuring that necessary actions have been taken to effectively resolve identified issues
• Spearhead and collaborate in process improvement initiatives
• Monitor processes and provide necessary process improvements trainings
• Lead investigations into quality issues and client complaints, ultimately working to identify corrective and preventative actions through a growth mindset approach
• Prepare and provide reports outlining identified Quality KPI measures
• Monitor, evaluate, and report on research project Lessons Learned findings and Customer Experience Survey results to support continuous improvement opportunities
• Lead RCA and CAPA development and management as needed

• Bachelor's degree in related field or equivalent experience

• Minimum 10 years of quality assurance and compliance experience or an equivalent combination of education and experience that gives the individual the necessary knowledge, skills, and abilities to perform the job
• Lean Six Sigma or other process improvement certification preferred

• Ability to effectively communicate and collaborate with cross-functional teams to understand and uncover patterns of quality issues, provide thoughtful recommendations, and develop efficient processes leading to improved quality
• Experience leading teams through internal and external audits, including facilitation of Root Cause Analysis (RCA) and Corrective and Preventive Action plans (CAPAs)
• Excellent verbal and written communication skills
• Ability to juggle multiple initiatives at once
• Strict attention to detail and quality
• Excellent organizational and time management skills
• A quantitative mindset with demonstrated experience making data-driven decision
• Ability to handle sensitive and confidential information appropriately
• Strong problem analysis and problem-solving skills
• A team-oriented mindset with the initiative to contribute ideas, share learnings, and accomplish goals
• Ability to advocate for quality in all aspects of company operations
• Experience working in a research setting with scientific teams (e.g. biostatisticians and epidemiologists) is a plus
• Experience working with remote teams is a plus