Associate Director, Compliance And Audit - GCP

Job Summary:

The Associate Director, QA Compliance is responsible for optimizing internal and external adherence to Quality and Regulatory Compliance by ensuring conformance to domestic and international quality regulations and guidelines in the areas of GCP, GLP, GCLP, and GPvP. This role will independently and collaboratively lead the development, implementation, and maintenance of Arcus internal, external audit and inspection readiness programs as well as individually participate e to the execution of these programs. This role is accountable for leading day-to-day QA Compliance operations in conformance with Arcus Biosciences processes and procedures.

This position reports to the Sr. Director of QA Compliance.

Job Responsibilities:

• Manages Arcus' corporate audit programs (internal and external audits) by engaging with internal stakeholders to identify vendor qualification needs and ensuring timely establishment and approval of annual audit programs.

• Collaborates with cross-functional organizations regarding ongoing risk assessment of contract service providers (CSP) such as CROs and other clinical vendors and facilitates timely planning and execution of CSP qualifications.

• Assist with the development and management of the auditor qualification, training requirements and develop effective auditing tools.

• Participate in the development, implementation and continuous improvement of inspection readiness and pre-approval inspection preparation processes and tools with study and functional area leadership, applicable partners and CROs.

• Maintains 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.

• Develops, collects, analyses, and reports key compliance metrics during management reviews to help ensure internal and external adherence to quality compliance expectations and advise stakeholders on improvement opportunities.

• Participate to the development, implementation and maintenance of procedures and templates to assist in the evaluation of the compliance and audit programs.

• Develop, review and monitor quality agreements and collaborate with peers and stakeholders to ensure timely completion and vendor qualification.

• Manage all aspects of the audit lifecycle such as scheduling planning, issuing agendas, audit execution, issuing reports evaluating responses, requesting clarification, issuing CAPA, and closing for GCP /GLP/GCLP/GPvP contract service providers.

• Clearly presents audit findings and/or other related audit information to appropriate departmental personnel, as required. Escalates issues to appropriate levels of management for resolution, as appropriate.

• Work directly with auditees to ensure completion of correct CAPA to address compliance concerns identified during an audit.

• Provides QA consultation and support to Arcus project teams by serving as a resource during projects.

• Supports Quality Assurance activities during partner audits and/or regulatory inspections, as assigned.

• Identifies and escalates significant compliance issues to Quality Assurance leadership and relevant functional area leadership.

• Supports strategic organizational quality and compliance process improvement initiatives (as assigned).

Qualifications:

• Bachelor of Science/ Bachelor of Art in a relevant discipline required (Bioanalytical/Biochemistry preferred.)

• 5+ years in an internal and vendor auditor role for in GCP /GLP/GCLP/GPvP field.

• Previous Quality Assurance experience that provided the knowledge, skills and abilities to perform the expectations outlined in this job description. Quality Auditor / Manager Certification, preferred.

• Experience with technologies used to conduct audits in a remote/virtual environment.

• Excellent working knowledge and interpretation of ICH Guidelines including E6(R2) and GCP /GLP/GCLP/GPvP domestic and international regulations.

• Experience auditing CROs, Bioanalytical Laboratories and other GCP vendors supporting clinical studies as well as performing eTMF audits.

• 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.

• Demonstrated strength in analytical and strategic assessment of regulatory compliance risks and the ability to articulate potential business impact.

• Highly self-motivated, well-organized, confident, possess a solution-oriented mindset and able to develop innovative solutions to issues.

• Strong computer literacy in Microsoft Office Suite (Word, Excel, Project, Visio, PowerPoint, etc.) and Veeva Vault platform applications.

Travel, Physical Demands, and Work Environment

• Regularly required to operate computer and other standard office equipment for varying durations that may include extended periods of time.

• Regularly required to sit for long periods of time, and occasionally stand and walk.

• Willing to travel domestically and internationally approximately 30% of time, per business needs.

This role can be based at our Hayward or Brisbane, CA locations (preferred) or can work remotely.

This role can be based at our Hayward or Brisbane, CA locations (preferred) or can be remote based. The anticipated salary range for fully qualified candidates applying for this position is $170,000 - $185,000 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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