Senior Manager, GCP QA

Senior Manager, GCP QA at Mind Med

Mind Med is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Our mission is to be the global leader in the development and delivery of treatments that unlock new opportunities to improve patient outcomes. We are developing a pipeline of innovative product candidates, with and without acute perceptual effects, targeting neurotransmitter pathways that play key roles in brain health.

Founded in 2019, we are continuously expanding our presence and global footprint. We are constantly searching for high‑impact individuals in various clinical, technical and business operations domains to strengthen our team of patient‑centric, intelligent individuals.

• 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 and present findings verbally and in writing to ensure clear understanding of deficiencies.
• Conduct QA audits and reviews of protocols and reports as assigned, 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 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).
• 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.
• Support the preparation, coordination, and management of regulatory agency inspections.
• Develop and deliver training to staff 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 at 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.
• Bachelor’s in a scientific field, or a bachelor’s in a non‑science field with an additional 2 years relevant work experience preferred.
• Documented training on and knowledge of current FDA regulations and GCPs.
• Experience in conducting, reporting, and responding to GCP vendor audits, clinical investigator audits, and protocol and report audits.
• Proficien…