Senior Manager, GCP Quality Assurance

2 weeks ago


Lexington, Kentucky, United States GQR Full time

Position: Senior Manager, GCP Quality Assurance

Employment Type: Full-time, direct hire.

Work Arrangement: Hybrid model with three days onsite.

Salary Range: $190,000 to $200,000 plus annual bonus and equity.

This position demands a seasoned Clinical Quality expert with a minimum of eight years of experience in Good Clinical Practice (GCP) and Clinical Trials.

Role Overview: The Senior Manager, GCP Quality Assurance will offer specialized knowledge and direction on Good Clinical Practice (GCP) and relevant regulations to clinical and nonclinical development teams, aiming to proactively identify compliance challenges and propose solutions.

Key Responsibilities:

  • Possess advanced expertise in managing quality incidents and GCP deviations, including conducting thorough root cause analyses and formulating Corrective and Preventive Action (CAPA) plans to mitigate risks to the organization, safety, and data integrity.
  • Demonstrated experience in supporting clinical study protocols, Informed Consent processes, and Clinical Study Reports is preferred.
  • Deliver expert guidance in GCP, compliance interpretation, consultation, training, and recommendations to clinical development teams and program stakeholders.
  • Lead inquiries into significant quality concerns, scientific misconduct, and suspected serious breaches of GCP or GLP; facilitate root cause identification and the development of suitable corrective and preventive measures; ensure tracking of actions and validation of effectiveness; oversee reporting of potential or confirmed violations to regulatory bodies as necessary. Manage deviations and CAPAs until resolution.
  • Identify and address GCP activities and process enhancement initiatives as directed by management.

Qualifications:

  • A Bachelor’s degree in a scientific field is mandatory; an advanced degree is preferred.
  • A minimum of eight years of clinical trial experience in a pharmaceutical, biotech, hospital environment, or a Contract Research Organization (CRO) is essential, with at least five years in a management role.
  • Comprehensive knowledge and/or understanding of ICH GCP and applicable global regulations and guidelines for clinical development.


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