Associate Director, CQA

Summary

The Associate Director, Clinical Quality Assurance is responsible for working with study management teams to facilitate internal and external adherence to Quality and Regulatory Compliance by ensuring conformance to domestic and international quality regulations and GCP guidelines. The role is accountable for participating in day-to-day QA Compliance operations in conformance with Arcus Biosciences processes and procedures.

This position supports the Clinical Quality Assurance function by providing GCP compliance oversight and support to Arcus Clinical Development therapeutic areas. A 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.  Responsibilities also include inspection readiness planning, management of health authority inspections and audits by external development partners, management of clinical audit programs, and oversight of consultant auditors.  This role will lead audits of investigator sites, internal functional/process audits, and audits of clinical vendors (GCP, GCLP, GPvP).

This position reports to the Senior Director of Clinical Quality Assurance

Responsibilities

• Support clinical study teams as a core team member for assigned studies through attendance at study management team meetings, review of study documents, and QA consultation on GCP-related questions
• Identify and escalate serious non-compliance issues to Clinical QA and Quality group leadership, including the assessment of serious breaches
• Maintain a high level of expertise in global GCP regulations and internal policies and procedures that impact clinical study conduct
• Clinical QA point of contact for specific clinical functional areas to support study and non-study specific projects
• Support the management of study-specific deviations/events/CAPAs in the GCP/PV space
• Collaborate with CRO quality counterparts as delegated, including participation in QA-QA meetings
• Participate in internal and external GCP audits as assigned in support of the execution of the audit programs and support the management of audit lifecycle activities as assigned, such as scheduling planning, issuing agendas, audit execution, issuing reports evaluating responses, requesting clarification, issuing CAPA, and audit closing
• Maintain up to date audit execution results in Arcus electronic quality management system (Veeva Quality Vault, preferred) and report compliance trends based on internal / external regulatory observations to ensure business continuity
• Clearly present audit findings and/or other related audit information to appropriate departmental personnel, as required
• Work directly with auditees to ensure completion of corrective and preventative actions to address compliance concerns identified during audits
• Support Quality Assurance activities during partner audits and/or regulatory inspections, as assigned
• Participate in inspection readiness and pre-approval inspection preparation activities and collaborate with study and functional area teams, applicable partners and CROs as assigned

• Support strategic organizational quality and compliance process improvement initiatives
• Support Investigator Site Audits

Qualifications

• Bachelor of Science/ Bachelor of Art in a relevant discipline required (Biological or Life Sciences preferred)
• 8+ years in pharmaceutical drug development in Clinical Quality Assurance and/or GCP-related discipline.
• Previous experience working with clinical study teams required
• Excellent working knowledge and interpretation of ICH Guidelines and GCP domestic and international regulations.
• Experience leading audits of GCP/GCLP/GPvP vendors, investigator sites, and internal audits of clinical functional areas
• Experience managing inspection readiness activities and supporting FDA, EMA, and other health authority inspections.
• Must have the ability to build and maintain positive relationships with department management, peers, and other colleagues across the organization.
• Self-motivated with the ability to take initiative, ownership and manage multiple responsibilities while shifting priorities quickly under tight timelines.
• Must have excellent customer-service orientation, high degree of professionalism, and ability to work with limited direction.
• Excellent oral and written communication skills.

Must possess mobility to work in a standard office setting and use standard office equipment, including a computer; vision to read printed materials and a computer screen; and hearing and speech to communicate in person, before groups, and over the telephone. This is primarily a sedentary office classification although standing in work areas and walking between work areas may be required. Finger dexterity is needed to access, enter, and retrieve data using a computer keyboard, mouse, or calculator, and to operate standard office equipment. Positions in this classification occasionally bend, stoop, kneel, reach, push, and pull drawers open and closed to retrieve and file information. Employees must possess the ability to lift, carry, push, and pull materials and objects weighing up to 25 pounds.