AD Clinical Quality Assurance
AD Clinical Quality Assurance
Posted on :
14-02-2025
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1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
14-02-2025
Job Description
Job Title: AD Clinical Quality Assurance (Audits & Inspections) (Office OR Remote)
Job Location: Brisbane 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
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
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
- A minimum of 8 to 10 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) European (EMA MHRA) and ICH Guidelines.
- Knowledge of Good Pharmacovigilance Practices or experience working in a Safety/PV role.
- Knowledge of Good Clinical Laboratory Practices.
- 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.
- 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 riskbased approach to quality and ownership of quality across functional lines.
- Highly selfmotivated wellorganized and confident with a solutionoriented mindset. Able to develop innovative solutions to problems.
- Ability to influence people at different levels and negotiate crossfunctionally 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
- Bachelor’s degree or higher in a medical or health sciences related field (advanced degree preferred).
- Ability to travel up to approximately 30% domestic and international as needed.
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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Employment Type
Full Time
Key Skills
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