Quality Assurance Specialist IV

Quality Assurance Specialist IV

At Mindlance, we strive to deliver value through the combination of right people, processes, technologies and program management solutions. Our methods include applying domain expertise in specific industry segments, utilizing a highly-skilled workforce, leveraging a proven global delivery model, implementing structured and scalable quality processes and methodologies and yet, staying cost-effective. All in all, our expertise lies in providing trained and committed minds to help meet your business objectives, irrespective of the stage your business is in.

Job Title:

Clinical Quality Assurance IV

Duration: 6 Months+

Location:

New Haven, CT

Job Description:

• Develop and implement quality management plan for each assigned program
• Interpret and provide key metrics to Global Development Team Leader and cross-functional development team members
• Support GCP SOP development and serve as quality operations reviewer.
• Execute risk-based methodologies for the planning and execution of clinical protocols, assuring an ongoing cycle for Plan – Do – Check – Act
• Manage quality issues including audit reports, quality issues/incidents, and CAPA development, working closely with RDQ audit team and clinical development. Ensure timely implementation and closure of CAPAs.
• Facilitate the assessment and investigation of quality issues, by driving root cause analysis and remediation. Provide expertise and recommendations. Ensure timely review and closure of quality issues.
• Assure appropriate escalations and notification to line management
• Lead inspection readiness and inspection preparation activities, including SME training/preparation and back room activities, and manage back room during GCP inspections. Analyze the risks, propose the strategy for readiness and manage the implementation of readiness program. Provide lessons learned after each GCP inspection.
• Use knowledge of GCP, clinical development, and industry best practices in order to provide guidance, training and input to business partners on compliance issues. Able to adapt precedent and develop creative and effective solutions to solve problems.

Qualification:

• Minimum of 9 years of experience pharmaceutical or biotechnology drug development experience
• Experience managing clinical quality activities and knowledge of clinical operations
• Comprehensive knowledge of all pertinent regulations
• Education:
  
  Bachelor's degree required. Masters preferred
• Languages:
  
  English Read Write Speak