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.

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 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.

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, internal process) and manage the GCP audit process for self-performed audits and outsourced audits.
• Support GCP regulatory inspections and manage assigned CAPAs identified during inspections.
• Other duties as assigned.

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, and effective problem-solving 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.

Additional Information

The 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