Shionogi's Associate Director, GCP/GVP Quality Assurance is needed to provide senior-level quality oversight for clinical development and pharmacovigilance activities, ensuring compliance with global regulatory requirements, identifying compliance risks, and driving resolution of quality issues.
Requirements
- Strong working knowledge of global GCP/GVP regulations and guidelines (ICH, FDA, EMA, MHRA, PMDA, and other local authorities).
- Demonstrated experience in planning, conducting, and/or managing audits of investigator sites, CROs, vendors, and internal processes; direct experience supporting global regulatory inspections.
- Solid background in CAPA management, root cause analysis, and vendor quality oversight, including execution of Quality Agreements.
- Deep understanding of compliance frameworks with the ability to interpret complex regulatory requirements and translate them into practical solutions.
- Strong analytical and decision-making skills to evaluate issues, identify risks, and recommend corrective actions.
- Skilled at managing multiple priorities, audits, and projects simultaneously within agreed timelines.
- Operates with a high degree of autonomy, demonstrates judgment in escalating issues, and models accountability in execution.
Responsibilities
- Provide quality oversight of clinical trial operations and PV to ensure GCP and GVP regulatory compliance with ICH, FDA, EMA, PMDA, MHRA, additional local regulatory requirements and global guidance.
- Serve as QA Representative to assigned clinical study teams and advisory to PV.
- Evaluate clinical trial documentation, processes, and study plans to ensure alignment with Shionogi’s expectations and regulatory requirements.
- Provide interpretation and evaluation to clarify or resolve GCP and GVP compliance issues for clinical, PV, cross functions impacting clinical trial and PV operations.
- Develop and ensure the GCP and GVP audit plan(s) is(are) executed via a risk-based approach and maintained to stay current as part of quality oversight.
- Plan, conduct, and/or manage internal processes, systems, and external audits including but not limited to audits of clinical investigator sites, CROs, vendors, phase I units, labs, business or licensing partners, distributors.
- Manage quality investigations, deviations, root cause analysis, and the implementation of Corrective and Preventive Actions (CAPAs).
Other
- Ability and willingness to travel up to 25% of the year both domestically and internationally.
- Must live a commutable distance to our US Corporate Headquarters in Florham Park, NJ. Office presence required 50% per month, at least 2-3 days per week.
- Effective at working cross-functionally and with external partners/vendors; capable of influencing without direct authority.
- Excellent written and verbal communication skills, with the ability to articulate regulatory expectations and quality standards to diverse audiences.
- Strong interpersonal awareness, adaptability, and resilience when operating in ambiguous or changing environments.
