Senior Manager, GCP QA

Shionogi & Co., Ltd•Florham Park, NJ

53d•$135,000 - $165,000

About The Position

We are seeking an experienced Sr. Manager, GCP QA, to join our team. This role is crucial for ensuring quality oversight of clinical studies and vendor programs, maintaining compliance with ICH GCP and FDA regulatory requirements, and upholding our high standards for data integrity. The ideal candidate will collaborate with clinical study teams and internal departments to assess and mitigate risks associated with vendors.

Requirements

BA/BS in life sciences, a scientific, technical discipline, or a related field.
Minimum of 4 years of experience in a GCP QA/quality/compliance role supporting clinical study teams.
Working knowledge of GCP regulations and guidelines, including ICH, FDA, EMA, and PMDA requirements.
Experience in performing GCP-related audits.

Nice To Haves

Strong attention to detail, excellent communication skills, strong critical thinking skills, and effective problem-solving abilities.
Experience with various types of clinical trials and familiarity with additional regulatory environments.
GVP experience desired

Responsibilities

Provide quality oversight and GCP guidance to clinical study teams and CROs/vendors to ensure compliance with ICH GCP and FDA regulatory requirements, as well as Shionogi standards.
Ensure clinical trials adhere to GCP principles, producing high-quality and reliable data.
Evaluate clinical trial documentation, processes, and study plans to ensure alignment with Shionogi's expectations and regulatory requirements.
Interpret and evaluate clinical and regulatory compliance requirements in coordination with the GCP QA team to meet company obligations.
Collaborate with clinical study teams to provide vendor quality oversight, identify risks, and propose remediation actions. Conduct regular vendor audits or assessments.
Develop, as needed, and ensure the GCP audit plan(s) is(are) executed for assigned clinical studies as part of quality oversight.
Work with internal cross-functional teams to assess risks associated with vendors and implement risk mitigation strategies to ensure product quality, study compliance, data integrity, and patient safety.
Maintain up-to-date knowledge of applicable regulations, industry standards, and Shionogi GCP standards and their interpretations.
Provide guidance on quality and compliance issues, ensuring adherence to applicable regulations, guidelines, and company policies.
Evaluate the effectiveness of CAPAs and follow up on audit findings to ensure timely resolution.
Perform GCP audits (e.g., CRO, vendor, investigator site, TMF) and manage the GCP audit process for self-performed audits and outsourced audits.
Support GCP regulatory inspections and manage assigned CAPAs identified during inspections.