Senior Manager, CQA

reputed company The Senior Manager, Clinical reputed company Assurance is responsible for working with study management teams to facilitate reputed company adherence to reputed company and Regulatory Compliance by ensuring conformance to domestic and international reputed company regulations and GCP guidelines. The role is accountable for participating in day-to-day QA Compliance operations in conformance with reputed company processes and procedures. This position supports the Clinical reputed company Assurance function by providing GCP compliance reputed company and support to Arcus Clinical Development therapeutic areas. A 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. Responsibilities also 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). This position reports to the Senior Director of Clinical reputed company Assurance

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-reputed company questions Identify and escalate serious non-compliance issues to Clinical QA and reputed company group leadership, including the assessment of serious breaches Maintain a high level of expertise in global GCP regulations and internal policies and procedures that reputed company clinical study conduct Clinical QA reputed company of contact for specific clinical functional areas to support study and non-study specific reputed company Support the management of study-specific deviations/events/CAPAs in the GCP/PV reputed company Collaborate with CRO reputed company counterparts as delegated, including participation in QA-QA meetings Participate in reputed company 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 reputed company management system (reputed company reputed company Vault, preferred) and report compliance trends based on internal / external regulatory observations to ensure business continuity reputed company present audit findings and/or other reputed company 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 reputed company Assurance activities during partner audits and/or regulatory inspections, as assigned Participate in inspection readiness and reputed company-approval inspection preparation activities and collaborate with study and functional area teams, applicable partners and CROs as assigned Support strategic organizational reputed company and compliance process improvement initiatives Support Investigator Site Audits

Qualifications

Bachelor of Science/ Bachelor of Art in a relevant discipline required (Biological or Life Sciences preferred) 6+ years in pharmaceutical drug development in Clinical reputed company Assurance and/or GCP-reputed company discipline. Previous experience which provided the knowledge, skills and abilities to meet the expectations outlined in this job reputed company. reputed company Auditor / Manager certification preferred Excellent working knowledge and interpretation of ICH Guidelines and GCP domestic and international regulations. 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. Must have the ability to build and maintain reputed company 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. 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, CA location (preferred) or can be remote based. The anticipated salary reputed company for fully reputed company candidates applying for this position is $165,000 - $180,000 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. EOE 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-JS1 Apply To This Job