Senior Manager, GCP QA

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 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 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.

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 GCP-related audits.

Competencies

• Strong attention to detail.
• Team player.
• Agile.
• Excellent communication skills.
• Strong critical thinking skills.
• Effective problem-solving abilities.

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.