AD Clinical Quality Assurance

Job Title : AD Clinical Quality Assurance (Audits & Inspections) (Office OR Remote)

Job Location : Hayward CA USA

Job Location Type : Remote

Job Contract Type : Fulltime

Job Seniority Level : MidSenior level

Description

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 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).

As a GCP compliance expert the AD / Director of Clinical Quality Assurance (Audits & Inspections) will utilize a riskbased and phaseappropriate 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 / Director of Clinical Quality Assurance will partner with clinical functional areas to develop / revise Policies SOPs and Work Instructions. This role will work closely with colleagues on the CQA (Study Compliance) team to support ongoing quality / compliance oversight and guidance for study management teams. This role may mentor junior members of the CQA organization as they gain auditing experience develop their auditing skills and work toward becoming fully qualified GCP auditors.

The AD / Director of Clinical Quality Assurance will actively contribute to the development maintenance and implementation of GCPrelated 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 Senior Director of Clinical Quality Assurance (Audits & Inspections).

Responsibilities

• Identify and escalate significant compliance issues to Clinical QA and other relevant leadership.
• Maintain high level of expertise in global GCP regulations and internal policies and procedures that impact clinical study conduct.
• Lead external GCP / GCLP / GPvP audits of clinical vendors.
• Lead investigator site audits for clinical studies.
• Perform internal GCP audits of clinical functions.
• Manage annual audit programs to ensure compliance with Arcus auditing SOPs and Clinical Study Audit Plans.
• Oversee and support GCPrelated CAPAs and process deviations.
• Establish relationship with CRO and development partner 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 riskmanaged solutions are implemented in a timely fashion
• Support Inspection Readiness activities and make recommendations for its continuous improvement
• Support health authority inspections of Arcus clinical vendors and investigator sites.
• Participate in quality and compliance initiatives as assigned

Requirements

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 $185000 $195000 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 marketbased salary Arcus offers the opportunity to participate in stock programs a performancebased bonus and a comprehensive benefits package. Additional information about our total rewards program can be found here :

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 nondisqualifying physical or mental disability national origin veteran status or any other legally protected status. EOE / AA / Vets

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Key Skills

Test Cases,SQL,Quality Assurance,Agile,TFS,Jira,Software Testing,Test Automation,Cucumber,QA / QC,SDLC,Selenium

Employment Type : Full Time

Vacancy : 1

Salary : $185,000 - $195,000