Manager, CMC QA

Manager, CMC QA

MindMed 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.

Responsibilities :

• Reports directly to the Associate Director of CMC QA, supporting CMC / GMP
• Review master batch records, master labeling / packaging records, product specifications and other process related documents from contract sites
• Perform batch record and data review / approval
• Review and / or approve deviations, OOSs, CAPAs, change control in an efficient manner for adequate and timely closeout of these events (internal and third party as relevant)
• Review and approve manufacturing and analytical validation protocols and reports.
• Support CMC QA document review, as assigned
• Assist in complaint investigations
• Review and approve product stability protocol and reports
• Assist in GMP Vendor audit and audit action completion. 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
• Assist with Internal QA Audits, as assigned, ensuring timely conduct, reporting, and follow-up
• Perform initial and / or technical review of draft quality agreements prior to signatory review
• Utilize eQMS for quality workflows and for effective tracking, trending, and reporting of quality data and information
• 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
• Participate in Computer System Validation and Testing
• Draft Validation documentation (protocols, reports) for eQMS workflows
• Review and sign off on validation and testing documentation
• Support GMP Vendor Document archival
• Develop and deliver, staff training on topics related to Quality, GxP Compliance, SOPs, and Risk Management
• Perform other quality assurance advisory duties as assigned by the Associate Director of CMC QA

Job characteristics :

Requirements :

The starting base pay range for this position is $105,556.00 - $139,388.00. Compensation will be determined based on several factors including, but not limited to, skill set, years of experience, and the employee's geographic location.