Summary of Position
Viela Bio is looking for a talented and highly motivated Associate Director, Quality Assurance and Compliance – Clinical. This person will be responsible for leading quality and compliance activities for GCP, GLP and GPvP in clinical trials globally. This includes the operation and continuous improvement of the Quality System in support of the Viela Bio’s pipeline.
The position oversees the clinical trial audit function and represents Viela Bio as the key QA liaison with external vendors and CROs. The position will also be responsible for implementing the company’s clinical quality systems and compliance strategies involving clinical trials working with key business partners in clinical and nonclinical to assure compliance with regulatory expectations utilizing risk-based approaches. Input on key global QA/Compliance and business initiatives as well as Support during Regulatory Inspections and 3rd party audits.
Work closely with key stakeholders in the development and implementation of GxP related quality systems and training of Viela staff. Develop and routinely monitor metrics to ensure compliance with operational oversight plans. Able to manage/plan/execute audits of investigator sites, documents, Trial Master Files, vendors, and internal and external processes.
Assure quality awareness in conducting clinical studies and convey confidence in clinical knowledge providing a high understanding of clinical processes. Expected to routinely interact with CROs, vendors and testing Labs to promote collaboration with these external partners to ensure all systems, processes, and their outcomes are in compliance with applicable standards, international regulations and guidelines. Must have ability to actively leverage audit outcomes and trends to achieve sustained improvement in conducting clinical trials.
- Provides guidance to personnel performing investigations, root cause analysis, CAPAs and deviations associated with oversight of clinical trial execution.
- Point person to identify and communicate GxP quality and compliance risks and participate in determination of appropriate plan for resolving the issues and addressing risks.
- Works with clinical operations to develop and manage audit programs with appropriate risk assessment and mitigations for both internal and external audits.
- Participates in cross-functional teams providing guidance and risk-based options representing Clinical QA on project teams.
- Reviews clinical study documents and checks for consistency and appropriate standards and practices as applicable.
- Provides resource planning and appropriate budget management of FTEs, consultants and contractors.
- Hosts and manages regulatory and 3rd party audits and inspections.
- Executes GxP Quality systems including Vendor Oversight, Documentation Management, training and GXP audits.
- Ensures compliance with applicable internal and external regulations, standards, policies and procedures related to the quality and regulatory status and performance of company operations, processes and products, including GLP, GCP & GPvP.
- Work with clinical, medical affairs, bio-statistics, research and data management as an active cross-functional team member to ensure the appropriate document/data integrity for regulatory submission and regulatory inspections to ensure that the organization is inspection ready.
Desired Skills and Experiences:
- 12+ years of direct clinical (GCP, GLP and/or GPvP) Quality Assurance experience in regulated industry (pharma/biotech).
- Broad knowledge of risk-based quality systems approaches consistent with ICH E-6(R2) for Good Clinical Practice (GCP).
- Strong knowledge of GxPs related to clinical activities including but not limited to Good Clinical Practices (FDA and ICH), safety monitoring, clinical laboratories and the ability to identify and/or resolve quality issues/discrepancies with others in a proactive, diplomatic, flexible and constructive manner.
- Experience in leading inspection-readiness activities for FDA, MHRA, EMA, PMDA and other international regulatory agencies as applicable.
- Maintains good working relationships and communication with all staff, contractor, consultants and external partners.
- Extensive experience with electronic quality systems approaches and implementation of such systems.
- Experience with user acceptance testing for external systems.
- Understanding of requirements/documentation of system validation.
- Knowledge of drug development, study design, data and trials management, procedures and documentation practices.
- Able to work in a fast–paced environment while handling multiple demands and shifting priorities with flexibility and willingness to adapt in a changing environment.
- Excellent communication skills, both verbal and written, strong analytical skills and attention to detail.
- BA/BS (or MS or Ph.D.) in any Life Science discipline is required.
Please click HERE to submit your resume and cover letter. (Make sure to click Upload button on bottom left after your file selections)