QA Specialist

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 Head of Quality Assurance (QA), supporting QA needs for GCP (Good Clinical Practice), GLP (Good Laboratory Practice), GMP (Good Manufacturing Practice), and GVP (Good Pharmacovigilance Practice) areas of the business (collectively referred to as “GxP”)
• Manages GMP Vendor Document archival
• Manages routing of GMP controlled documents for review and approval in the electronic quality management system (eQMS)
• Utilizes eQMS for quality workflows and for the effective tracking, trending, and reporting of quality data and information
• Prepares agenda and minutes for Quality Assurance meetings and Information Systems Steering Committee meetings, as assigned
• Performs other document organization and archival tasks as assigned
• Assists with tracking and managing non-GMP external, internal, investigator site, CSR and TMF audit activities including:
• Entering audits, audit findings and outcomes into the eQMS
• Tracking and filing required documentation into the eQMS
• Creating the External Audit Finding Summary and Responses template for external audits
• Maintaining the non-GMP Audit Tracker
• Assists with tracking non-GMP quality incidents, deviations and CAPAs within the eQMS
• Performs quality control (QC) checks of eQMS data on an ongoing basis (e.g., training reminders, linked documents, Q-Sheets, glossary)
• Assists with review of new and updated policies and procedures (e.g., cross check, formatting, roles)
• Assists with SOP tracking and project management of SOP development initiatives
• Assists with project management of Corporate QA Initiatives
• Performs other quality assurance support duties as assigned by the Head of QA

Job characteristics:

• Working independently in a geographically distributed team, receiving task assignments from members of QA Management/Leadership.
• 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
• Applying document management and project management skills to ensure timely and accurate completion of QA tasks

Requirements:

• Required:  Associate’s Degree or higher.  Preference will be given to applicants with Bachelor’s Degree or higher
• Experience and expertise in document management and control
• Proficient written and verbal communication skills
• Proficient in use of Microsoft Office applications and email.  Preference will be given to applicants experienced with electronic quality management systems and project management applications
• Ability to collaborate effectively with cross functional team members and external partners
• Ability to manage multiple QA activities across multiple programs and studies
• A can-do attitude and excellent attention to detail

The starting base pay range for this position is $69,680.00 - $85,635.00. 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!