Associate/Director, Clinical Quality Assurance

Job Description:

This position supports the Clinical Quality team by providing GCP compliance oversight and support to Arcus Clinical Development therapeutic areas and clinical study teams. The key activity of the role is providing expertise and guidance regarding regulatory requirements, GCP guidelines and Arcus Standard Operating Procedures (SOPs) for the conduct of clinical studies.

As an expert, the Associate/Director, Clinical Quality Assurance will utilize a risk-based strategy to prioritize GCP QA support for clinical trial activities, identify and escalate compliance issues, enable pro-active decision-making, and support the development and execution of effective and comprehensive action plans to address quality and compliance risks. In addition, the Associate/Director, Clinical Quality Assurance will partner with Clinical Operations, Clinical Sciences, Regulatory, Safety and other key functions to enable transparency and escalation of quality and compliance matters.

The Associate/Director, Clinical Quality Assurance will actively contribute to the development and implementation of Policy/Standard Operating Process /Procedures in addition to tools, and templates deemed controlled in supporting regulatory requirements for application in drug development and clinical trial execution within Arcus Clinical organization. This position reports to Sr. Director of Quality Assurance. Actual job title will commensurate with experience and skill sets.

Key Responsibilities:

• Collaborate with stakeholders in conducting ongoing risk assessment of clinical trial activity in order to identify priority studies, compliance metrics for tracking, high-risk Service Providers, and key clinical QA activities (i.e. protocol review, service provider evaluations, inspection readiness).
• Conduct and/or oversee external GCP audits of clinical service providers, CROs, and suppliers.
• Conduct and/or oversee Investigator site audits for applicable clinical trials.
• Conduct and/or oversee internal process audits for clinical and pharmacovigilance functions.
• Identify and escalate significant compliance issues to clinical QA and relevant leadership, including the assessment of serious breaches.
• Participate as member of clinical study teams for assigned Therapeutic Areas/Studies.
• Establish relationship with CRO Quality Team members for the ongoing review of quality and compliance issues.
• Identify and anticipate trends in quality issues and collaborate with department management to ensure risk-managed solutions are implemented in a timely fashion
• Maintain high level of expertise in international GCP regulations and internal policies and procedures that may impact drug development.
• Provide support and guidance during and following internal audits and external regulatory inspections (as required)
• Support Inspection Readiness activities and make recommendations for its continuous improvement
• Participate on quality and compliance initiatives, as assigned

Requirements:

• A strong team player with great interpersonal and written communication skills
• Demonstrated strength in analytical and strategic assessment of regulatory compliance risks and the ability to articulate potential business impact.
• Must be flexible and comfortable with a risk-based approach to quality and ownership of quality across functional lines.
• Highly self-motivated, well-organized, confident, possess a solution-oriented mindset and able to develop innovative solutions to issues.
• Ability to influence people at different levels and negotiate cross-functionally in matrix organization to resolve conflicts.
• Ability to build and sustain meaningful relationships with business stakeholders and partners.
• Bachelor's degree in scientific, health sciences or quality-related field.
• A minimum of 8 to 10 years in a pharmaceutical drug development in a GCP related discipline.
• Expert knowledge of international GCP drug development regulations, including USA (FDA), EU (EMA, MHRA) and ICH Guidelines.
• Strong computer literacy in MS Word, Excel, Project, Visio, PowerPoint and Veeva Vault platform applications
• Ability to travel up to 20% post COVID