Associate Director, GCP QA

Shionogi Inc.•Florham Park, NJ

3d•$160,000 - $190,000•Hybrid

About The Position

The Associate Director, GCP Quality Assurance provides senior-level quality oversight for Shionogi’s clinical development activities, ensuring compliance with ICH, FDA, EMA, PMDA, MHRA, and other global regulatory requirements. Serving as the QA representative and advisor to assigned study teams, this role evaluates processes, practices, documentation, and study plans to identify compliance risks and drive resolution of quality issues. The incumbent plans, conducts, and manages risk-based audits of investigator sites, CROs, vendors, and internal processes, ensuring timely and effective CAPA implementation. They support regulatory inspection readiness, provide regulatory interpretation to mitigate risks and address potential compliance concerns. Working with cross-functional partners and external vendors, the Associate Director drives risk mitigation strategies to safeguard patient safety, data integrity, and product quality. The role also contributes to the development, review, and enhancement of QA standards, policies, and training materials to strengthen Shionogi’s quality system and culture. Operating with a high degree of independence, the Associate Director influences across functions and geographies while remaining hands-on in execution of audits, inspections, and quality investigations.

Requirements

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 in clinical development.
Strong working knowledge of global GCP regulations and guidelines (ICH, FDA, EMA, MHRA, PMDA, and other local authorities).
Demonstrated experience, including but not limited to, 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 in execution.
Strong interpersonal awareness, adaptability, and resilience when operating in ambiguous or changing environments.

Responsibilities

Provide quality oversight of clinical trial conduct to ensure GCP regulatory compliance with ICH, FDA, EMA, PMDA, MHRA, additional local regulatory requirements and global guidance.
Serve as QA Representative and advisory to the assigned clinical study team(s).
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 compliance issues for clinical and cross functions impacting clinical trial development.
Develop and ensure the GCP 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.
Follow up on audits, ensure proper closure with effective CAPAs in a timely manner.
Active in preparing Shionogi’s readiness for GCP 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 Clinical 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.
Engage in providing GCP feedback on relevant training materials for implementation.
Other duties as assigned.