Associate Director, Clinical Quality Assurance
Locations: Hayward/SF-Brisbane/Remote
This position supports the Clinical Quality Assurance function 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 applicable regulatory, Good Clinical Practice, and Arcus Standard Operating Procedure requirements for the conduct of clinical studies.
As a GCP compliance expert, the AD of Clinical Quality Assurance will utilize a risk-based and phase-appropriate strategy to prioritize GCP QA support for clinical trial activities, identify and escalate compliance issues, enable proactive decision making, and support the development and execution of effective and comprehensive action plans to address quality and compliance risks. In addition, the AD of 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 AD of Clinical Quality Assurance will actively contribute to the development, maintenance, and implementation of GCP-related policies and SOPs. This role will participate in the management of systems relevant to the administration of the Clinical QMS in support of regulatory requirements for application in drug development and clinical trial execution within the Arcus Clinical Organization. Participation in GCP auditing activities may also be assigned based on experience. This position reports to the Sr. Director of Clinical Quality Assurance.
Responsibilities:
- Support clinical study teams for assigned studies through attendance at study meetings, review of study documents, and consultation on GCP-related questions.
- Identify and escalate significant compliance issues to Clinical QA and other relevant leadership, including the assessment of serious breaches.
- Maintain high level of expertise in global GCP regulations and internal policies and procedures that impact clinical study conduct.
- Conduct and/or support external GCP audits of CROs and other clinical vendors.
- Conduct and/or support Investigator site audits for applicable clinical studies.
- Conduct and/or support internal GCP audits for clinical functions.
- Oversee and support GCP-related CAPAs and process deviations.
- Collaborate with stakeholders in conducting ongoing risk assessments of clinical study activity 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).
- 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
- 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 in quality and compliance initiatives, as assigned
Qualifications:
- Bachelor’s degree or higher in a medical or health sciences related field.
- A minimum of 6 to 8 years of experience in a GCP related discipline. Prior experience as a CRA, Study Coordinator, or in clinical study management is strongly preferred.
- Expert knowledge of global GCP requirements and applicable drug development regulations, including USA (FDA), EU (EMA, MHRA), and ICH Guidelines.
- 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, and confident, with a solution-oriented mindset. Able to develop innovative solutions to issues.
- Ability to influence people at different levels and negotiate cross-functionally in a matrix organization to resolve conflicts.
- Ability to build and sustain meaningful relationships with business stakeholders and partners.
- Strong computer literacy in MS Word, Excel, Project, Visio, PowerPoint and Veeva Vault platform applications
- Ability to travel up to 20%
Arcus Biosciences is an equal opportunity employer