Quality Assurance Manager
About Concerto HealthAI
Concerto HealthAI is the leading provider of precision health clinical and commercial real-world data and AI solutions to the global pharma community and across the broader healthcare landscape. Our mission is to accelerate drug development, clinical trials, and HEOR analytics to dramatically improve patient outcomes.
Concerto HealthAI is part of a select set of companies backed by SymphonyAI Group (SAI) the largest AI-focused investment firm in the world, which was founded and is led by Dr. Romesh Wadhwani, a highly successful serial tech entrepreneur, investor, and philanthropist. Dr. Wadhwani has committed $1 billion in capital to build SAI’s portfolio companies into global leaders that deliver extraordinary new value across diverse industries.
Concerto HealthAI is seeking a talented QA Manager to join our growing organization to coordinate and maintain the QMS programs, to ensure adherence to internal and regulatory requirements. The QA Manager will be directly responsible for maintaining current understanding of regulatory environment, rends, and best practices related to quality activities of Concerto HealthAI.
- Work with Quality team members to develop, implement, and maintain a phase appropriate Quality Management System (QMS) through the creation, review and approval of documentation including policies and standard operating procedures (SOPs) as per the internal and applicable regulatory environment
- Exercise sound and balanced judgment in ensuring that written procedures are followed and in evaluating quality systems, processes, procedures, plans and protocols for compliance
- Champion Training Management Program. Along with QA Team - prepare training materials and provide trainings, as needed.
- Investigate, triage and document quality issues/deviations, and recommend corrective actions/CAPAs
- Work with functional leaders to implement corrective and preventive actions in response to observations
- Management and review of trends and report significant investigation/deviation issues and system deficiencies to senior management, as appropriate
- Lead efforts to ensure readiness for audits and inspections
- Assist in DR and BC efforts
- Assist in maintaining all QA Master files
- Participate in quality and process improvement initiatives and project teams.
- Identify opportunities for process and system improvement and enhancement.
- Prepare and analyze/trend various Quality events for escalation and prevention.
- Evaluate questions and issues received from end users, make decision on appropriate follow-up steps based on established processes, procedures and guidelines, and escalate to supervisor as appropriate.
- Work with and assist Quality team members to maintain the internal and external audit programs
- Must have Bachelor’s Degree
- Must have 7+ years of quality assurance experience OR Master’s Degree with 5+ years of quality assurance experience
- Knowledge of inspection and quality control methods, techniques, and documentation.
- Self-starter with ability to work in ever changing QA environment.
- Excellent organizational skills, excellent oral and written communication skills.
- Pharma IT-QA, GCP-QA experience is preferred
- Must be familiar with:
- GCP, Part 11 compliance, GDPR, Real World Evidence
Nice to Haves
- Proficient in Microsoft, PDFs and Electronic QMS.
- Comprehensive knowledge of good documentation practices and document control concepts.
- Knowledge of quality assurance principals, best practices, and quality systems used in a Real World Research environment.
- Demonstrated ability to coordinate process improvement initiatives and quality system related projects.
- Knowledge of both domestic and international other relevant regulations.
- Demonstrated ability to interact and communicate effectively with peers, senior management, regulatory officials, auditors, contractors and consultants.
Learn More About Concerto HealthAI
Concerto HealthAI is transforming how healthcare is delivered and dedicated to improving patient outcomes in oncology by offering innovative solutions on how data and intelligence is used to solve healthcare problems. We are creating something special in our culture, by building a collaborative, engaged, patient focused, team approach to our mission. Our high performance teams are looking to add great talent to the mix and we are hiring for the right mix of new skills and diverse mindset. Learn more about Concerto HealthAI at www.concertohealthai.com , or follow us on LinkedIn.