Senior Manager, GCP QA - Shionogi Inc. (U.S.) : Job Details

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.ResponsibilitiesQuality Oversight for Clinical Studies and Vendor Oversight Program:

• 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.

General Quality And Regulatory Compliance

• 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.

Audit Support

• 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.

Minimum 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.

Preferred Skills And Qualifications

• 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.

Additional InformationThe base salary range for this full-time position is $135,000 - $165,000. Individual pay is determined by several factors, which include but are not limited to: job-related skills, experience, and relevant education or training. The range does not include the comprehensive benefits, bonus, long-term incentive, applicable allowances, or any additional compensation that may be associated with this role.EEOShionogi Inc. is an equal opportunity employer supporting individuals with disabilities and veterans. All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race, color, religion, sex (including pregnancy), marital status, national origin, age, ancestry, citizenship, disability, genetic information, status as a disabled veteran, a recently separated veteran, Active Duty Wartime or Campaign Badge Veterans, and Armed Forces Service Medal Veterans, or any other characteristic protected by applicable law. It is the policy of Shionogi Inc. to undertake affirmative action for protected veterans and individuals with disabilities in compliance with all federal, state, and local requirements to recruit a diverse pool of protected veteran and individuals with disabilities applicants and to ensure that our employment practices are, in fact, non-discriminatory.If you are qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation if you are unable or limited in your ability to use or access this website to apply for a vacancy as a result of your disability. You can request accommodations by calling 973-###-#### or by sending an email to [email protected].

Seniority level

• Seniority levelMid-Senior level

Employment type

• Employment typeFull-time

Job function

• Job functionQuality Assurance and Science
• IndustriesPharmaceutical Manufacturing and Biotechnology Research

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