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 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.
Job characteristics:
- 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
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
The starting base pay range for this position is $140,000.00 - $173,116.00. Compensation will be determined based on several factors including, but not limited to, skill set, years of experience, and the employee’s geographic location.
Employees in this role may be entitled to additional compensation, including bonus and equity. Benefits information is listed on our Jobs Page. The Company provides competitive benefits to employees including:
- 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!