Sr. Manager, Clinical Quality Assurance

Responsibilities

• Promote a culture of compliance and quality
• Plan and develop proactive approaches to implement and coordinate continuous improvement of quality processes and systems that assure GCP compliance of clinical study-related activities conducted by 4DMT and in collaboration with 4DMT contract research organizations.
• Improve, maintain, and implement GCP and PV quality systems.
• Promote collaboration internally and with external partners to ensure all systems, processes, and their outcomes comply with applicable international and national standards, regulations, and guidelines
• Provide effective oversight and guidance on GCP regulations, standards and quality systems to clinical research and development cross-functional team members and contracted study vendors (attend internal Study Execution Team Meetings and corresponding external study meetings)
• Partner with QA and Clinical Operations to develop, author, review, and/or approve clinical quality assurance SOPs
• Oversee administration of Audits and CAPA system. Plan, manage and oversee Annual GCP Audit schedule, perform clinical supplier risk assessments, and evaluate vendors for potential use Ensure adherence to the approved Annual Internal Audit Schedule and External Audit Schedule. Ensure the corresponding workflows and documentation are maintained per procedures.
• Actively leverage audit outcomes/trends to achieve sustained improvement in clinical trial conduct while championing the highest standards of compliance.
• Identify, evaluate, and communicate risks to critical trial processes and data with recommendations for resolution
• Develop GCP training programs and lead training of company staff involved in execution of clinical trials and external partners in GCP compliance and 4DMT clinical practices and procedures
• Plan and oversee effective audits of documents (Protocol, IB, Master Template Inform Consent, CSR), Trial Master Files, and internal processes
• Support 4DMT GCP and PV inspection readiness
• Keep current on changes in industry and regulatory standards for GCP requirements and advises on business impact, evaluating the potential risk of compliance deficiencies if needed
• Other duties as assigned, nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time

Qualifications

• Bachelor's degree required; advanced degree in a scientific field preferred
• Experience:
• 5+ years of experience in Clinical Quality Assurance, Pharmacovigilance Quality Assurance or Clinical Operations Role.
• Broad knowledge of risk-based quality systems approaches consistent with ICH E6(R2) for Good Clinical Practice. Experience with all phases of clinical trials.
• Knowledge of Good Clinical Practices (FDA and ICH), Pharmacovigilance (FDA and EMA), a solid understanding of 21 CFR Part 11 with respect to clinical systems, including database, eCRF validation procedures, eCTD Quality Assurance, and eTMF requirements
• Skills:
• Project leadership experience; supervisor experience a plus (including site monitoring)
• Ability to identify and/or resolve quality issues/discrepancies with others in a proactive, diplomatic, flexible and constructive manner
• Attention to detail as well as a crisp, clear and concise style in written and oral communications
• Demonstrated ability to work independently and flexibly in a fast-paced, high growth environment
• Experience supporting inspection-readiness activities resulting in successful agency (FDA, EMA) inspections
• Ability to travel both domestic and internationally, as needed. Expected travel up to 15%.
• Physical Requirements:
• Adhere to 4DMT COVID protocols and policy 
• During the current COVID-19 pandemic, the ability to work remotely until it is safe to return to the worksite and work onsite once 4DMT deems it safe to return.