Senior Manager, GCP QA

Role Summary

Senior Manager, GCP QA responsible for leading GCP and GLP QA activities across designated clinical studies, ensuring compliance with quality management plans, and supporting regulatory readiness. This role involves conducting audits, managing quality issues, developing SOPs, and mentoring staff to uphold a strong quality culture within a geographically distributed team.

Responsibilities

• Reports to Director, GCP QA, supporting all GCP QA needs, and GLP QA needs, as assigned.
• Serves as QA primary point of contact for designated clinical studies, attending routine update meetings and ensuring the actioning and completion of study-specific QA activities; provides QA review of project-specific planning documents, as needed.
• Ensures compliance with Clinical Quality Management Plans for all assigned clinical trials
• Conducts Internal and external (vendor) QA Audits, as assigned, ensuring timely conduct, reporting, and follow up:
  • Schedule, conduct and provide timely reports of audits to assure conformance with the approved audit schedule, and to confirm compliance with regulations, guidelines, SOPs, and Industry standards.
  • Effectively communicate actionable findings to various staff levels. Effectively present findings to ensure clear understanding of deficiencies (verbal and written).
• Conduct QA Audits and Reviews, as assigned, of protocols and reports, to verify quality, consistency, and compliance
• Perform initial and/or technical review of draft GCP quality agreements prior to signatory review, as requested
• Utilize eQMS for quality workflows and for the effective tracking, trending, and reporting of quality data and information
• Plan and perform compliance audits of foreign and domestic clinical investigators to verify protection of human research participants, data integrity, and regulatory and protocol compliance.
• Write, revise, and periodically review SOPs to further develop the Quality System and control over compliance and the quality of data, vendor services, and products
• Manage quality issues and investigations, root cause analyses, risk assessments and risk impact analyses, as well as corrective and preventive actions (CAPAs)
• Clearly communicate quality, compliance, and audit issues to internal and external parties, professionally, and in a timely manner
• Support Regulatory Compliance and Inspection Activities:
  • Prepare investigators and vendors for potential/impending audits and inspections
  • Conduct QA review of project-specific documents, as assigned
  • Supports the preparation, coordination, and management of regulatory agency inspections
• Develop and deliver, staff training on topics related to Quality, GCP Compliance, Human Subject Protection, SOPs, and Risk Management.
• Perform other quality assurance advisory duties as assigned.

Qualifications

• Required: 7+ years working in GCP Quality Assurance and Clinical Program Management
• Required: Bachelors in scientific field, or Bachelors in non-science field with additional 2 years relevant work experience preferred
• Required: Documented training on and knowledge of current FDA Regulations and GCPs
• Required: Experience in conducting, reporting, responding to GCP vendor audits, clinical investigator audits, and protocol and report audits
• Required: Proficient written and verbal communication skills
• Required: Ability to collaborate effectively with cross functional team members and external partners
• Required: A can-do attitude and excellent attention to detail
• Required: This person may travel, domestically and internationally, up to 25% of the time

Skills

• Quality Assurance, GCP/GLP compliance
• Auditing (internal, external, vendor, clinical investigator)
• Regulatory inspections and regulatory readiness
• eQMS and quality-data management
• SOP development and CAPA management
• Cross-functional collaboration and stakeholder communication

Education

• Bachelors degree in a scientific field or equivalent experience; advanced degree preferred

Additional Requirements

• Travel up to 25% domestically and internationally