Manager, Clinical Quality Assurance

Arcus Biosciences•Hayward, CA

About The Position

This position supports the Arcus Clinical Quality Assurance (CQA) team and its annual objectives in supporting Arcus Clinical Development therapeutic areas and clinical study teams. The role actively supports management of clinical trial quality assurance activities and related objectives in the annual quality plan, using the quality management system, quality tools, and leadership guidance. Activities may include attending clinical trial team meetings; supporting study-related quality activities and development of study quality plans; overseeing clinical trial activities, including vendors and sub-vendors; supporting investigational medicinal product supply quality assurance; monitoring clinical trial quality activities; conducting effectiveness checks; developing reports; and tracking compliance with ICH-GCP and Arcus SOPs. The Manager may partner with other clinical functions to promote transparency and help address quality and compliance matters. The role routinely uses applicable regulations, guidance, policies, procedures, systems, trackers, tools, and templates. The position can be based at the Hayward, California location, which is preferred, or be remote. The anticipated annual salary range for fully qualified candidates is $130,000–$145,000. Arcus also offers participation in stock programs, a performance-based bonus, and a comprehensive benefits package.

Requirements

Bachelor’s degree in a scientific, health sciences, or quality-related field.
At least 3 years of experience in pharmaceutical drug development GCP and/or a Clinical QA-related discipline.
Training and knowledge in international GCP drug development regulations, including U.S. FDA, EU EMA and MHRA, and ICH-GCP guidelines.
Previous experience managing quality and GCP compliance issues.
Experience with cross-functional stakeholder management.
Strong knowledge of drug development processes from Phase I through Phase IV.
Flexibility and comfort with a risk-based approach to quality and ownership of quality across functional lines.
Ability to influence people and effect change; navigate and negotiate cross-functionally in a matrix organization to resolve conflicts; and build and sustain meaningful relationships with business stakeholders and partners.
Proactive, solution-oriented mindset and sound judgment in evaluating risks, guidance, and escalations.
Strong project management skills, including team leadership, consultative facilitation, risk analysis, follow-through, and project planning.
Strong interpersonal and organizational skills; self-motivation, teamwork, organization, confidence, and ability to develop innovative solutions.
Strong verbal and written communication, attention to detail, discretion, and critical-thinking skills.
Computer literacy with MS Word, Excel, Project, Visio, PowerPoint, and clinical and quality databases.
Ability to work in a standard office setting and use standard office equipment, including a computer; read printed materials and computer screens; and communicate in person, before groups, and over the telephone.
Ability to perform occasional bending, stooping, kneeling, reaching, and pushing or pulling drawers, and to lift, carry, push, and pull materials and objects weighing up to 25 pounds.

Nice To Haves

Quality certification.
Clinical Supply QA management experience.

Responsibilities

Collaborate with stakeholders to obtain current information for tracking clinical QA activities, such as database reports, form completion, critical form review, and inspection readiness.
Manage and maintain electronic quality management systems supporting ongoing clinical quality activities.
Support external GCP audits of clinical service providers, CROs, and suppliers.
Support investigator site audits for applicable clinical trials.
Support internal process audits for clinical and pharmacovigilance functions.
Identify and escalate significant compliance issues to clinical QA and relevant leadership, including assessing serious breaches, and support investigations into identified issues.
Participate in clinical study teams for assigned therapeutic areas and studies to help ensure compliance with ICH-GCP and applicable policies and procedures.
Establish relationships with CRO Quality Team members, as applicable, for ongoing review of quality and compliance issues.
Support development of GCP training presentations for Clinical functions based on identified needs.
Contribute to collecting audit and inspection trends and metrics for CQA monitoring, audits, investigations, updates, and presentations.
Complete tasks on time and provide status updates on open action items.
Maintain and develop expertise in international GCP regulations and internal policies and procedures that may affect drug development; seek questions, help, clarification, and guidance as needed.
Liaise with training functions to assess job-role training requirements and participate in developing and delivering GCP, SOP, or policy-related training as required.
Provide support and guidance during and after internal audits and external regulatory inspections as required.
Support the Inspection Readiness program and recommend continuous improvements.
Participate in quality and compliance initiatives as assigned.