Associate Director, GCP QA

Associate Director, GCP QA

Shionogi Inc. (U.S.) offers a senior-level quality oversight position ensuring compliance with ICH, FDA, EMA, PMDA, MHRA, and other global regulatory requirements.

Serving as the QA representative to assigned study teams and an advisor to PV, this role evaluates processes, practices, documentation, and study plans to identify compliance risks and drive resolution of quality issues.

• 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.
• Collaborate with the Global GVP QA teams in support of the QPPV Office to maintain PSMF up to date.
• 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.
• Follow up on audits, ensure proper closure with effective CAPAs in a timely manner.
• Active in preparing Shionogi’s readiness for GCP and GVP regulatory inspections.
• Provide regulatory inspection support.
• Manage quality investigations, deviations, root cause analysis, and the implementation of Corrective and Preventive Actions (CAPAs). Evaluate the effectiveness of CAPAs through timely closure.
• Act as a key Quality contact for external vendors as assigned, develop and execute Quality Agreements as applicable.
• Work with internal cross-functional teams impacting either Clinical or PV to assess risks associated with vendors and implement risk mitigation strategies to ensure product quality, study compliance, data integrity, and patient safety.
• Support the development, review and update of Shionogi standards for QA and standards impacting Clinical and PV.
• Engage in providing GCP or GVP feedback on relevant training materials for implementation.
• Other duties as assigned.

• BA/BS in life sciences, a scientific, technical discipline, or a related field.
• 7+ years of progressive experience in Quality Assurance, Compliance, or Regulatory roles supporting GCP and/or GVP in clinical development and pharmacovigilance.
• 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.
• Effective at working cross-functionally and with external partners/vendors; capable of influencing without direct authority.
• Effectively manages investigations and root cause analyses, drives timely and sustainable CAPA implementation, and ensures robust vendor quality oversight through execution of Quality Agreements and risk mitigation strategies.
• Excellent written and verbal communication skills, with the ability to articulate regulatory expectations and quality standards to diverse audiences.
• 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…