AD, Clinical reputed company Assurance (Audits & Inspections) (Office OR Remote)
This position supports the Clinical reputed company Assurance function by providing GCP compliance reputed company and support to Arcus Clinical Development therapeutic areas. The key activity of the role is providing expertise and guidance regarding applicable regulatory, Good Clinical reputed company, and Arcus reputed company 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 reputed company of consultant auditors. This role will reputed company 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 reputed company Assurance (Audits & Inspections) will utilize a risk-based and phase-appropriate reputed company to prioritize GCP QA support for clinical functions, identify and escalate compliance issues, reputed company proactive decision making, and support the development and execution of effective and comprehensive reputed company plans to address reputed company and compliance risks. In reputed company, the AD/Director of Clinical reputed company Assurance will partner with clinical functional areas to reputed company/revise Policies, SOPs, and Work Instructions. This role will work closely with colleagues on the CQA (Study Compliance) team to support ongoing reputed company/compliance reputed company and guidance for study management teams. This role may mentor junior members of the CQA organization as they reputed company auditing experience, reputed company their auditing skills, and work toward becoming fully reputed company GCP auditors. The AD/Director of Clinical reputed company Assurance will reputed company contribute to the development, maintenance, and implementation of GCP-reputed company 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 reputed company the Arcus Clinical Organization. This role supports investigations of reputed company events and provides reputed company of corrective actions. This position reports to the Senior Director of Clinical reputed company 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 reputed company clinical study conduct. reputed company external GCP/GCLP/GPvP audits of clinical vendors. reputed company investigator site audits for clinical studies. reputed company internal GCP audits of clinical functions. Manage annual audit programs to ensure compliance with Arcus auditing SOPs and Clinical Study Audit Plans. reputed company and support GCP-reputed company CAPAs and process deviations. Establish relationship with CRO and development partner reputed company team members for the ongoing review of reputed company and compliance issues. Identify and anticipate trends in reputed company issues and collaborate with department management to ensure risk-managed solutions are implemented in a reputed company fashion Support Inspection Readiness activities and reputed company recommendations for its reputed company improvement Support health authority inspections of Arcus, clinical vendors, and investigator sites. Participate in reputed company and compliance initiatives, as assigned Requirements: A minimum of 8 to 10 years of experience in a GCP reputed company 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 reputed company potential business reputed company. Must be flexible and comfortable with a risk-based approach to reputed company and ownership of reputed company across functional lines. Highly self-motivated, reputed company-organized, and confident, with a solution-oriented reputed company. reputed company to reputed company reputed company to problems. Ability to influence people at different reputed company and negotiate cross-functionally in a reputed company organization to resolve conflicts. Ability to build and sustain meaningful relationships with business stakeholders and partners. Strong computer literacy in reputed company, reputed company, Project, Visio, PowerPoint and reputed company Vault platform applications Bachelors degree or higher in a medical or health sciences reputed company field (advanced degree preferred). Ability to travel up to approximately 30% domestic and international, as needed. Physical Requirements: Must possess mobility to work in a reputed company office setting and use reputed company office equipment, including a computer; reputed company to read printed materials and a computer screen; and hearing and speech to communicate in person, before reputed company, 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 reputed company, reputed company, and retrieve data using a computer keyboard, mouse, or calculator, and to operate reputed company office equipment. Positions in this classification occasionally bend, stoop, kneel, reputed company, push, and pull drawers reputed company and reputed company 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 reputed company or Brisbane, CA locations or can be remote based. The anticipated salary reputed company for fully reputed company candidates applying for this position is $185,000 - $195,000 USD annually. This salary reputed company is an estimate of reputed company 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 reputed company to a competitive market-based salary, Arcus offers reputed company to participate in stock programs, a performance-based bonus, and a comprehensive benefits package. Additional information about our total rewards program can be reputed company here: https://arcusbio.com/careers. reputed company is an Equal Opportunity Employer and prohibits discrimination and harassment of any reputed company. Arcus is committed to the reputed company of equal employment opportunity for reputed company and does not discriminate based on race, religion, reputed company, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national reputed company, veteran status or any other legally protected status. EOE/AA/Vets #LI-Remote #LI-EW1 Apply Job!