Shionogi Inc. is the U.S. subsidiary of Shionogi & Co., Ltd., a leading Japanese pharmaceutical company with state of the art research capabilities that has provided innovative medicines essential to people's health for over 135 years.
In the US, Shionogi Inc. develops and commercializes pharmaceutical products that address unmet medical needs in the areas such as pain and anti-infectives.
As a colleague of Regulatory Affairs, the Clinical QA Senior Manager & GCP Auditor will serve as the QA representative on various clinical development projects, and be responsible for the overall management and implementation of the GCP
audit program, including the conduct of internal and external audits to assure adherence to relevant regulations, guidelines, strategy and procedures.
- Audit clinical trials including clinical investigator site audits, clinical vendor audits, directed audits, and other special audits and assessments to assess quality level and compliance with applicable GCP regulations in support of Shionogi clinical programs.
- Create formal audit reports and identify critical audit findings to senior management, including recommendations for corrective action and/or regulatory reporting, if necessary.
- Serve as QA representative on active clinical/development projects.
- Provide guidance and recommendations to the Clinical Operations department,
- Serve as resource for interpretation and evaluation of GCP compliance issues for Clinical Development, Quality Assurance, and Regulatory Affairs.
- Conduct internal audits.
- Coordinate PAI readiness activities.
- Conduct due diligence audits/activities.
- Review and approve audit responses.
- Ensure effective closure, by working with auditees to ensure comprehension, development and execution of corrective/preventive action with regard to any non-conformities cited during audits.
- Assist in preparing the audit schedule for the year.
- Assist in the management of the clinical audit program, including oversight of contract auditors as needed.
- Develop/modify audit checklists as regulatory requirements change.
- Conduct and support benchmarking activities.
- Lead development of process improvement strategies and tools related to GCP compliance efforts.
- Maintain required knowledge of applicable regulations and government, industry and company GCP standards and their interpretations by participating in industry trainings, workshops and discussion groups.
- Support the development and delivery of GCP training programs.
- Support of other QA projects as needed.
MINIMUM JOB REQUIREMENTS
- BA/BS in the life sciences required.
- At least 5 years of relevant pharmaceutical industry experience, including at least 4 years of GCP audit experience.
- Thorough knowledge of ICH Guidelines and GCPs including regulatory requirements for the conduct of clinical development programs.
- Familiarity with GLP and database audit practices a plus.
- Excellent oral, written and verbal communication skills.
- Appropriate technical skills in GCP compliance.
- Proven interpersonal skills.
- Ability to travel 60% max.
- International travel is required.
- Must live a commutable distance to our corporate offices in Florham Park, NJ.
To be considered for this position, you must apply online at: https://www.shionogi.com/careers/careers.html -- and meet the requirements of this opportunity. We look forward to reviewing your resume & qualifications.
- We are an Equal Opportunity Employer.
- Please view Equal Employment Opportunity Posters provided by OFCCP here.