Senior Manager, GCP QA

Summary

Join MindMed, a clinical-stage biopharmaceutical company, as a GCP QA professional. Reporting to the Director, GCP QA, you will be responsible for supporting all GCP QA needs and GLP QA needs. Key responsibilities include conducting internal and external audits, ensuring compliance with Clinical Quality Management Plans, managing quality issues and investigations, and supporting regulatory compliance and inspection activities. This role requires 7+ years of experience in GCP Quality Assurance and Clinical Program Management, a BA in a scientific field (or a non-science field with additional experience), and documented training on FDA Regulations and GCPs. The position offers a competitive salary, comprehensive health benefits, 401(k) matching, flexible time off, and generous parental leave. Domestic and international travel up to 25% is expected.

Requirements

• 7+ years working in GCP Quality Assurance and Clinical Program Management
• BA in scientific field, or BA in non-science field with additional 2 years relevant work experience
• 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

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

Benefits

• 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!
• Employees in this role may be entitled to additional compensation, including bonus and equity