Director, Gcp Quality Assurance

Responsibilities:

• Reports directly to the Head of Quality Assurance (QA), supporting QA needs for GCP (Good Clinical Practice), GLP (Good Laboratory Practice), and GVP (Good Pharmacovigilance Practice) areas of the business (collectively referred to as "non-GMP")
• Oversees the MindMed non-GMP Vendor Qualification Audit Program:
• Determine risk-based intervals for audits of non-GMP vendors and ensure compliance with agreed-upon schedules
• Conduct or assign the conduct of all scheduled non-GMP Vendor Qualification Audits, ensuring timely reporting and follow up
• 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, unless delegated
• Ensures the implementation of a risk-based Clinical Quality Management Plan for all clinical studies intended for registration
• Ensures the timely conduct, reporting, and follow up for non-GMP Internal 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)
• Ensures clinical study protocols and reports are reviewed to assure quality, consistency, and compliance
• Performs initial and/or technical review of draft GCP quality agreements prior to signatory review, as requested
• Works to maximize the use of the electronic quality management system (eQMS) for quality workflows and for the effective tracking, trending, and reporting of quality data and information
• Oversees the planning and performance of compliance audits of foreign and domestic clinical investigators to verify protection of human research participants, data integrity, and regulatory and protocol compliance
• Writes, revises, and periodically reviews SOPs to further develop the Quality System and control over compliance and the quality of data, vendor services, and products
• Ensures the timely and complete handling and documentation of quality incidents and investigations, root cause analyses, risk assessments and risk impact analyses, as well as corrective and preventive actions (CAPAs)
• Clearly communicates quality, compliance, and audit issues to internal and external parties, professionally, and in a timely manner
• Supports Regulatory Compliance and Inspection Activities:
• Oversees the preparation of investigators and vendors for potential/impending audits and inspections
• Conducts QA review of project-specific documents, as assigned
• Supports the preparation, coordination, and management of regulatory agency inspections
• Perform other Quality Assurance advisory duties as assigned by the Head of QA

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
• Skilled in negotiation and communicating internally and externally with personnel of all levels of seniority

Requirements:

• 8+ years working in GCP Quality Assurance and Quality Management
• BA in scientific field, or BA in non-science field with additional 2 years relevant work experience
• Advanced degree preferred
• Documented training on and knowledge of current FDA Regulations and GCPs
• Experience and expertise in conducting and reporting 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
• Ability to manage multiple QA activities across multiple programs and studies
• A can-do attitude and excellent attention to detail