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HUTCHMED · 2 days ago

Associate Director / Director, GCP/GLP QA

New Jersey, United States

Full-time

Onsite

Lead/Staff, Director/Executive

15+ years exp

HUTCHMED is seeking an Associate Director / Director for their GCP/GLP Quality Assurance team. The role involves maintaining the effectiveness of the global clinical quality management system, leading quality issue investigations, and driving continuous improvement in clinical trials quality.

BiopharmaBiotechnologyHealth CareMedicalPharmaceutical

Hiring Manager

Joyce Jiang

Responsibilities

Maintain the effectiveness of global clinical/GLP quality management system, including monitor US/EU/Japan clinical regulation updates and communicate the changes to global pre-clinical and clinical quality team

Contribute to Quality and Risk Management Framework across clinical and non-clinical R&D team

Lead quality issue investigation and CAPA approval

Drive continuous improvement in clinical trials quality

Lead international GCP/GVP inspections and partner audits

Regularly monitor US/EU/Japan regulation updates

Communicate the regulation updates (environment change) to the global Quality team

Ensure global QMS team remediating identified gaps

Collaborates with Hutchmed Clinical to perform risk assessments and identify key data/procedures and high-risk areas

Proactively analyze quality data and leverage quality indicators to identify potential trends and risks

In alignment with risk assessments, develop GCP quality strategy and oversight plan

Set up annual GCP/GLP audit pan based on risk assessment

Ensure conducting GCP/GLP audits per approved annual plan

Prepares, conducts audits assigned, generates audit reports on time, communicates results to relevant stakeholders (e.g. Vendors/Clinical Operations)

Oversee audits conducted by third party auditing company, including the review of audit plan, audit report, CAPA plan and tracking CAPAs to close out

Interacts with various teams to ensure properly performing root-cause analysis and developing corrective and preventative actions (CAPA)

Track CAPA closure with applicable QA inputs

Providing GCP compliance advice and guidance to study team

Lead Quality Issues investigation, including root cause analyses, remediation (corrective and preventative actions) action review

Ensure timely reporting critical quality issues to management team and authorities, e.g. potential misconduct and/or fraud

Lead inspection readiness and inspection management for the authority inspections happened ex-China

Develops and shares lessons leant with relevant stakeholders after inspection when necessary

Enhance QA procedures though updated SOPs, guidance documents and other tools

Provides training and mentorship to less experienced QA staff

Contributes to build the work climate/culture within QA function, exemplifies the leadership behaviors

Qualification

Clinical research experienceQuality management experienceClinical risk assessmentGCP compliance expertiseAudit experienceEnglish proficiencyChinese proficiencyLeadership skillsMentorship abilities