Senior Clinical QA Manager (GCP & Audits) - Remote

Arcus Biosciences, Inc.; Brisbane (CA); Remote; USD 130,000 - 145,000; Full time

Benefits offered by this job

Stock options

Performance bonus

Benefits package

Job summary

Arcus Biosciences, Inc. in Hayward, CA (remote possible) seeks a Manager, Clinical Quality Assurance to support the clinical QA program and annual quality plan. You will oversee QA activities, audits, and coordination across study teams to ensure ICH-GCP compliance and SOP adherence.

You will partner with clinical functions, CROs, and vendors, guiding investigations, training, and data reporting, while advancing inspection readiness and continuous quality improvements.

Qualifications

• Bachelor’s degree in scientific, health sciences or quality-related field.
• 3+ years in a pharmaceutical drug development GCP and/or Clinical QA related discipline.
• Trained and knowledgeable in international GCP drug development regulations, including USA (FDA), EU (EMA, MHRA) and ICH- GCP Guidelines.
• Previous experience managing quality and GCP compliance issues.
• Quality Certification and Clinical Supply QA Management experience is highly desirable
• Experience with cross-functional stakeholder management.
• Strong knowledge of the drug development processes (Ph I – IV)
• Must be flexible and comfortable with a risk-based approach to quality and ownership of quality across functional lines.
• Ability to influence people and affect change
• Ability to navigate and negotiate cross-functionally, in a matrix organization, to resolve conflicts.
• Ability to build and sustain meaningful relationships with business stakeholders and partners.
• Pro-active, solution-oriented mindset and sound judgment for evaluation of 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; Highly self-motivated, strong team-player, well-organized, confident, possesses a solution-oriented mindset and able to develop innovative solutions to issues.
• Strong verbal and written communication skills; detail oriented, uses discretion and critical thinking skills
• Strongcomputer literacy in MS Word, Excel, Project, Visio, PowerPoint., Clinical and Quality databases.

Responsibilities

• Collaborate with stakeholders, as needed, to gain up to date information for tracking key clinical QA activities (i.e., database reports, form completion, critical form review, inspection readiness).
• Manages and maintains electronic quality management systems in support of on-going clinical quality activities.
• Supports the conduct of external GCP audits of clinical service providers, CROs, and suppliers.
• Supports the conduct of Investigator site audits for applicable clinical trials.
• Supports the conduct of internal process audits for clinical and pharmacovigilance functions.
• Identifies and escalates significant compliance issues to clinical QA and relevant leadership, including the assessment of serious breaches. Supports investigations related to identified issues.
• Participates as member of clinical study teams for assigned Therapeutic Areas/Studies, in ensuring compliance with ICH- GCP and applicable policies and procedures.
• Establishes relationship with CRO Quality Team members (as applicable) for the ongoing review of quality and compliance issues.
• Supports presentation development for GCP training to Clinical functions based on identified needs.
• Contributes to data collection of audit and inspection trends and metrics for CQA monitoring, audits, investigations, updates and presentations.
• Timely completion of tasks and follows-up with status updates on open action items.
• Maintains and further develops expertise in international GCP regulations and internal policies and procedures (using reference material) that may impact drug development. Asks questions, ask for help or clarification, and guidance, as needed.
• Liaise with respective training functions to assess job role training requirements and participate in the development and execution of GCP, SOP or policy-related training (as required)
• Provide support and guidance during and following internal audits and external regulatory inspections (as required)
• Support Inspection Readiness program and make recommendations for its continuous improvement
• Participate on quality and compliance initiatives, as assigned

Skills

Project management

Stakeholder management

Risk analysis

Change management

Communication skills

Cross-functional collaboration

Training & guidance

Education

Bachelor’s degree in scientific/health sciences/quality field

Tools

MS Word

Excel

Project

Visio

PowerPoint

Clinical databases

Quality databases

Job description

Arcus Biosciences, Inc. in Hayward, CA (remote possible) seeks a Manager, Clinical Quality Assurance to support the clinical QA program and annual quality plan. You will oversee QA activities, audits, and coordination across study teams to ensure ICH-GCP compliance and SOP adherence.

You will partner with clinical functions, CROs, and vendors, guiding investigations, training, and data reporting, while advancing inspection readiness and continuous quality improvements.