Associate Director, Quality Assurance & Training
At DiCE Molecules, we design and develop innovative therapies in immunology for patients with debilitating disease. Seeking to create a future where convenient oral medicines with biologic-like efficacy are available to patients with serious medical conditions, we are developing oral alternatives to medicines currently limited to injectable forms.
In this role, which is a contract assignment with potential to convert to full-time, you will provide direct support to the Leadership team in managing compliance related to GxP, pharmacovigilance, regulatory, and other related activities. The individual will provide compliance support to the DiCE Development organization by designing, developing, monitoring, maintaining, and continuously improving the GxP Quality System.
This position is responsible for the development and maintenance of quality programs, systems, processes, and procedures that ensure compliance with policies and that the performance and quality of services conform to established standards and agency guidelines. Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and agency guidelines to assure compliance. Provides process analyses oversight on a continuing basis to enforce requirements and meet guidelines. Leads audit and inspection preparation, resolution of audit and inspection findings, and liaises with auditing groups and inspectors through all stages of the audits for global clinical Trial Master Files, Pharmacovigilance System Master files and others, needed. Ensures DiCE’s quality assurance programs and policies are maintained and modified regularly. The Associate Director, Quality Assurance may indirectly oversee contingent, consultant, and other external worker(s) or vendors who are responsible for Development activities. He/she will be accountable to assure adherence to GxP in the conduct of clinical trials, the quality and integrity of generated data, and the rights and welfare of participants/patients.
- Lead review of quality oversight related to critical processes to identify, assess, and advise cross-functional colleagues on compliance risks, gaps in standards, procedures or technologies that are a risk to clinical trial quality
- Work with cross-functional teams to develop, prioritize and implement quality plans based on prospective data to reduce/mitigate risk to clinical trial quality. Provide effective oversight of quality systems across Research and Development in collaboration with a cross-functional team.
- Lead the development, implementation, and maintenance of GCP Quality Systems and SOPs. Provide training and overall guidance to the Development organization on compliance requirements. Analyze deviations between SOPs and observed actions and determines if the actions must be corrected or the SOPs must be modified.
- Coordinate, manage, and facilitate compliance /training processes to provide timely deliverables.
- Actively participate in Clinical Operations meetings and provide timely CQA KPI updates to the Head of Clinical Operations.
- Review and provide input to clinical documents (protocols, ICFs, study plans, etc.). Author Clinical Quality plans.
- Train and mentor staff on global GCP regulations and guidelines. Ensure in-house GCP /GxP training requirements are met.
- Identify quality and compliance-related issues and implement practical solutions while ensuring timelines are maintained. Ensure best practices are actively shared across functions.
- 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.
- Lead assessment and selection of potential CQA-related vendors in support of Development activities (TMF vendors, etc)
- Design Clinical QA documentation and repositories for all development studies to ensure maintenance of Clinical Quality documentation.
- Lead quality review /audit of Clinical Study Reports.
- Lead QA oversight and audit of eTMFs.
- Lead CAPA activities and/or for cause audits, where necessary
- Support qualification assessments for CROs, Vendors, and sites, as requested.
- Assist in the preparation, execution and follow up activities related to internal and external regulatory audits, and inspections. Lead mock inspection audits, as needed.
- Prepare and conduct internal and external vendor inspections and audits and maintain the schedule or required audits to maintain compliance.
- Lead the development of responses for internal system audits and/or regulatory inspections that address identification of actual root cause and improvements needed to support preventing findings in future
- Demonstrate a high level of involvement in continuous improvement of quality assurance philosophy and practices to ensure the highest standards are maintained.
- Participate in and/or lead forums and process improvement/system initiatives critical to quality processes such as essential document management, data management, trial management, investigational product management, etc.
Preferred Experience and Education:
· Bachelor’s degree in a scientific field preferred
· Minimum 8 years in the pharmaceutical or biotech industry experience in a Clinical Quality Assurance or Quality Assurance role and at least 5 years of direct experience with GxP auditing and inspections OR in Clinical Development or Operations directly managing compliance of global clinical trials.
· Early Development experience required. GMP/GLP experience a plus.
· Broad knowledge of risk-based quality systems approaches consistent with ICH E-6(R1 &R2) for Good Clinical Practice.
· Knowledge of Good Clinical Practices (FDA and ICH), a solid understanding of 21 CFR Part 11, 50,54,56, & 312 with respect to clinical systems, including database, eCRF validation procedures, eCTD Quality Assurance, and eTMF requirements.
· Current and working knowledge interpretation/implementation of government and other local state/government regulations/requirements governing the ability to work in a clinical setting required.
· Prior experience in root cause analysis, risk assessment, and prospective indicators of quality issues is desired. Auditor training or certification a plus.
· Extensive knowledge and understanding of Clinical Development Programs, Clinical Trial processes as well as quality management and control tools are required.
· Requires experience in immunology therapeutic areas, specifically related to design /quality oversight of trials
· Experience developing and delivering effective CAPA management solutions.
· Proven ability to manage multiple projects while maintaining quality.
· Proactive, energetic, self-assured professional with high personal integrity and the ability to develop good interpersonal relationships with stakeholders.
· Demonstrated success in analyzing, interpreting, and solving complex issues across multiple functions in support of conducting quality global clinical trials.
· Ability to think strategically and objectively and with creativity and innovation.
· Demonstrated understanding of laws, regulations, standards, and guidance governing the conduct of clinical studies, as well as preparation of clinical documentation in support of regulatory submissions required.
· Strong interpersonal skills with a reputation for collaboration with colleagues.
· Excellent leadership skills /ability to lead cross-functional teams of professionals.
· Excellent communication, organizational, and time-management skills
· Strong computer skills including MS Office (Word, Excel, PowerPoint, MS Project).
· Position can be based remotely.
The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.