Manager/Senior Manager, Clinical Quality Assurance

Hiring under Eisai Clinical Research Singapore Pte Ltd

Job Description

The Manager/Senior Manager, Clinical Quality Assurance, will plan, prepare, perform, and report on audits of clinical investigational sites and vendors for clinical studies in Asia Pacific. This person will also lead in health authority inspection activities in this region and provide GCP consultation to clinical study teams. These actions ensure that a high level of quality and compliance is maintained in clinical research activities.

Primary Responsibilities

Audits

1. Accountable for the quality and integrity of assigned Audit Plans
2. Prepares and conducts routine, complex and for-cause audits
3. Authors and peer reviews audit reports
4. Communicates audit outcome to vendors, clinical investigators and internal stakeholders
5. Provide QA support and guidance to stakeholders in developing root cause analysis and CAPA to audit findings

Regulatory Inspections

1. Lead and facilitate inspection preparation activities for APAC regulatory inspections
2. Collaborate with stakeholders in inspection response commitment activities to develop root cause analysis and CAPAs

Training, Guidance and SOP reviews

1. Consult on latest GCP guidance
2. Assess, prepare and deliver GCP training, lessons learnt as needed
3. Contributes or leads departmental transformational projects

Resource Management

1. Enhances the capabilities of current resources (tools, systems, vendors, etc.), technologies, and processes for the team
2. May manage contractors and ensure that contractors, consultants and vendors complete assigned work according to agreed timelines

Compliance

1. Complies with all applicable laws / regulations of each country in which we do business

Others

1. Develops & maintains good relationship with internal or external stakeholders, demonstrating high ethical behaviour at all times
2. Trains junior team members on processes and/or systems
3. Performs risk analyses for global projects
4. Other duties as assigned

Qualifications

• Bachelor of Science or Master of Science in relevant field
• At least 3 years experience in GCP auditing required (position offered will be based on experience)
• Proficiency in written, spoken, and reading English and Mandarin is mandatory
• Strong analytical and report writing skills
• Ability to travel at least 30%