AD, Clinical Quality Assurance (Study Compliance) (Office OR Remote)

This position supports the Clinical Quality Assurance function by providing GCP compliance oversight and support to Arcus Clinical Development therapeutic areas. 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.  Primary responsibilities will include 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. This role may also participate in investigator site audits, internal functional/process audits, and clinical vendors (GCP, GCLP, GPvP) as assigned.As a GCP compliance expert, the Associate Director (AD) Clinical Quality Assurance (Study Compliance) will utilize a risk-based and phase-appropriate strategy to prioritize GCP QA support for clinical functions, 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 Clinical Quality Assurance will partner with clinical functional areas to develop/revise policies, SOPs, and work instructions, as needed.  This role will work closely with colleagues on the CQA (Audits and Inspections) team to support audits and inspection activities.The AD 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. This role supports investigations of quality events and provides oversight of corrective actions. This position reports to the Director of Clinical Quality Assurance (Study Compliance).  Key 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
• Occasionally 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

Requirements:

• Bachelor of Science/ Bachelor of Art in a relevant discipline required (Biological or Life Sciences preferred)
• Minimum of 8+ years in pharmaceutical drug development in Clinical Quality Assurance and/or GCP-related discipline. 
• Previous experience which provided the knowledge, skills and abilities to meet the expectations outlined in this job description.
• Excellent working knowledge and interpretation of ICH Guidelines and GCP domestic and international regulations.
• 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 
• Some experience auditing clinical investigator sites and/or GCP vendors is preferred
• Ability to travel up to approximately 15% domestic and international, as needed.

Physical Requirements: 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.  This role can be based at our Hayward or Brisbane, CA locations or can be remote based. The anticipated salary range for fully qualified candidates applying for this position is $185,000 - $195,000 USD annually. This salary range is an estimate of what we reasonably expect to pay for this posted position. The actual salary may vary based on various factors including, without limitation, individual education, experience, tenure, skills and abilities, internal equity and alignment with market data. In addition to a competitive market-based salary, Arcus offers the opportunity to participate in stock programs, a performance-based bonus, and a comprehensive benefits package. Additional information about our total rewards program can be found here: https://arcusbio.com/careers. 

Arcus Biosciences is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Arcus is committed to the principle of equal employment opportunity for all employees and does not discriminate based on race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets 

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