Senior Manager, GCP QA
- 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.
- Working independently in a geographically distributed team
- Being proactive, target-driven, and diligent
- Working with multiple stakeholders and managing multiple priorities
- Contributing to an overall culture of quality within the organization
- Participating in cross-functional conversations and decision-making around complex quality, compliance, and risk situations
- Skillfully negotiating and communicating internally and externally with personnel of all levels of seniority
- Managing assigned projects and tasks according to agreed-upon timelines, ensuring alignment with overall project management plans
- 7+ years working in GCP Quality Assurance and Clinical Program Management
- Bachelors in scientific field, or Bachelors in non-science field with additional 2 years relevant work experience preferred
- Documented training on and knowledge of current FDA Regulations and GCPs
- Experience in conducting, reporting, responding to GCP vendor audits, clinical investigator audits, and protocol and report audits
- Proficient written and verbal communication skills
- Ability to collaborate effectively with cross functional team members and external partners
- A can-do attitude and excellent attention to detail
- This person may travel, domestically and internationally, up to 25% of the time
- 100% paid health benefits including Medical, Dental and Vision for you and your dependents
- 401(k) program with company match and immediate vesting
- Flexible time off
- Generous parental leave and some fun fringe perks!
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