QA GCP Contractor

2 weeks ago

Florham Park, United States Shionogi Inc. Full time

Overview:

We are seeking an experienced QA Contractor 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.

Responsibilities:

Quality 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 Shionogis 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 (Preferred Skills):

  • 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.

Essential Physical Requirements

  • Ability to articulate clearly and conduct verbal presentations with large and small audiences.
  • Ability to travel via automobile and/or airplane.
  • Ability to view video display terminal images < 18 away from face for extended period of time up to four (4) hours at a time.
  • Ability to operate a computer keyboard and telephone.
  • Ability to sit for extended periods of time up to four (4) hours at a time.
  • Ability to lift, tug, pull up to fifteen (15) pounds.

To be considered for this position, you must apply and meet the requirements of this opportunity.

We look forward to reviewing your resume & qualifications.

DISCLAIMER

The job description is not designed to cover or contain a comprehensive listing of requirements, duties or responsibilities that are required of the employee. Other requirements, duties and responsibilities may change or be assigned at any time with or without notice.

EEO:

Shionogi Inc. is an equal opportunity/affirmative action employer.

All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity, 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 in compliance with all federal, state, and local requirements to recruit a diverse pool of applicants and to ensure that our employment practices are, in fact, non-discriminatory.

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