Senior Auditor, Vendor Audit (contract)

About the role

Premier Research is seeking a Senior Auditor, Vendor Audit to join our Functional Services Provider (FSP) team. This role supports biotech, medtech, and specialty pharma companies in transforming life-changing ideas into new medicines, devices, and diagnostics. As a valued member of the team, you play a crucial role in ensuring compliance and quality.

Responsibilities

• Organizes and hosts Vendor audits to support global operations, including preparation of audit plans, checklists, reports, and certificates.
• Manages complex audit activities according to the Premier Research Vendor audit schedule and ensures the approved vendor list remains updated.
• Collaborates with operational teams to review and trend documented Vendor issues and gaps for potential systemic issues.
• Documents and implements corrective actions at a global level, including reviewing contracts as necessary.
• Serves as the Point of Contact (POC) for vendor audit activities.
• Ensures compliance with internal control procedures by examining records, reports, operating practices, and documentation.
• Communicates audit findings through final reports and discussions with auditees.

Requirements

• Bachelor’s degree, or international equivalent, in Health or Life Sciences, or equivalent experience.
• 5-8 years specialized GxP experience in auditing (vendor audits, GCP audits, GMP audits), or 8+ years relevant experience with 5+ years’ experience conducting Vendor audits.
• Demonstrated ability to independently review databases, trial master files, investigator sites, statistical/clinical study reports, vendors, manufacturers, master batch records, device history files, laboratories, and system validation documentation.
• Demonstrated knowledge of ICH Guidelines, FDA Code of Federal Regulations, and other applicable regulatory authority laws and regulations.

Qualifications

• Ability to interpret controlled documentation (protocols, validation documents, manufacturing records and data).

Skills

• Strong organizational and communication skills.
• Ability to manage multiple projects simultaneously.
• Proficiency in regulatory compliance and auditing processes.

Benefits

Joining Premier Research offers a competitive compensation package, including a starting hourly rate of $70/hr USD, which can vary based on qualifications and experience. The company is committed to providing a supportive and inclusive environment where your contributions are valued.

Pay

$70/hr USD (subject to negotiation based on qualifications)

Schedule

Part-time 6-month 1099 contractor opportunity

Location

Preferred Location: East Coast