Senior Manager GCP QA Clinical Studies and Vendor Oversight
Senior Manager GCP QA Clinical Studies and Vendor Oversight
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1 Vacancy
Job Description
Overview
We are seeking an experienced Senior 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 provide advisory and 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 highquality 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 CRO or 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. Conduct investigator site audits or TMF audits.
- Work with internal crossfunctional 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 uptodate 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 internal process) and manage the GCP audit process for selfperformed audits and outsourced audits.
- Support GCP regulatory inspections and manage assigned CAPAs identified during inspections.
- Other duties as assigned.
Minimum Job Requirements
Qualifications
- BA/BS in life sciences a scientific technical discipline or a related field.
- Minimum of 5 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 GCPrelated audits.
Competencies
- Strong attention to detail team player agile excellent communication skills strong critical thinking skills and effective problemsolving abilities.
- Experience with various types of clinical trials and familiarity with additional regulatory environments.
- Capable of operating in an ambiguous environment.
- Capable of operating independently with a leveled understanding of decision making.
Other Requirements
- 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 at least 50 of the time per month.
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 nondiscriminatory.
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 callingor by sending an email to
Required Experience:
Senior Manager
Employment Type
Full-Time
