Shionogi Inc. (U.S.) · 6 days ago
Associate Director, GCP QA
Florham Park, NJ
Full-time
Hybrid
Senior Level, Lead/Staff, Director/Executive
$160K/yr - $190K/yr
7+ years expShionogi Inc. is a pharmaceutical company focused on clinical development and pharmacovigilance. The Associate Director, GCP QA is responsible for providing senior-level quality oversight, ensuring compliance with global regulatory requirements, and managing risk-based audits to safeguard patient safety and product quality.
Pharmaceuticals
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
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
Qualification
Required
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 in execution
Strong interpersonal awareness, adaptability, and resilience when operating in ambiguous or changing environments
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
Company
Shionogi Inc. (U.S.)
Since 1878, we have been committed to developing new treatments to improve patients' lives worldwide.
501-1000 employees
H1B Sponsorship
Shionogi Inc. (U.S.) has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (5)
2024 (2)
2023 (6)
2022 (5)
2021 (2)
2020 (7)
Funding
Current Stage
Late StageLeadership Team
Nathan Mccutcheon
US President and CEO
Margaret Borys, CPA, MBA
SVP & Chief Commercial Officer
Company data provided by crunchbase