GCP Auditor​/Senior; Sr.) Auditor, Quality Assurance

Position: GCP Auditor/Senior (Sr.) Auditor, Quality Assurance

GCP Auditor/Senior (Sr.) Auditor, Quality Assurance

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About USDM

USDM Life Sciences is a premier consulting company with 20+ years of experience assisting heavily regulated biotech, medical device, and pharmaceutical companies with their GxP technologies to accelerate growth. Our deep domain knowledge and technology expertise in life sciences business processes are what set us apart. From strategy to implementation and adoption, we have delivered thousands of GxP projects globally. As part of the USDM team, you have the opportunity to work with cutting‑edge technologies through our many partnerships with companies like Microsoft, Google, Oracle, Docu Sign, Box, and many more.

Nature

and Scope of Job

The GCP Quality Assurance Auditor will focus on ensuring GXP compliance with regulatory authorities, driving and implementing the Company’s compliance directives and supporting quality management systems to ensure compliance and minimize risk in a regulated pharmaceutical environment. The incumbent will conduct and or participate in all GXP QA audit programs which include both internal and external GXP audits. This position will provide day‑to‑day support to the GXP QA Director in clinical operations/Non‑clinical and Manufacturing to manage CROs, CMOs, investigator sites, and all relevant vendors to support clinical trials.

Primary

Responsibilities

• Plan and conduct scheduled global clinical process and clinical vendor audits across all clinical trials.
• Plan and conduct audits of specific clinical processes based on risk.
• Perform clinical vendor audits along with various SMEs (IRT, EDC, etc.) to comprehensively assess all services provided by a vendor.
• Develop audit reports and distribute them to appropriate stakeholders.
• Own and manage related clinical vendor non‑conformances.
• Review, understand, and audit clinical related regulations and guidelines (e.g. FDA regs, GCP, etc.).
• Collaborate with clinical sourcing, supplier quality and clinical partnership to manage clinical vendors.
• Support the preparation, coordination, and participation of regulatory agency inspections.
• Participate in and support quality improvement projects.

Additional Responsibilities

• Perform other related duties and assignments as required.

Qualifications

• The GCP Quality Assurance Auditor will work with the QA and cross‑functional teams, communicate with QA consultants, and have contact with external auditees, vendors, partners, and affiliates.
• The ideal candidate will have extensive GCP experience.
• Perform and manage all types of audits in the audit program of Clinical Development and Safety Pharmacovigilance.
• 5+ years of pharmaceutical experience.
• Experience with both internal and external process and systems audits.
• Strong knowledge of development policies, procedures and standards (SOPs, QMS).
• Ability to work with global clinical teams in developing objectives for audits of clinical studies.

Education & Certifications

• BS degree in scientific, health care or related discipline.
• Intensive GCP and safety background.

Working Conditions

• Prolonged periods of sitting or standing at a desk and working on a computer in an environmentally controlled home office environment.
• Operate other office productivity machinery, such as a calculator, scanner, or printer.
• Frequently communicate with stakeholders via telephone, email, or instant message. Must be able to exchange accurate information in these situations.

Equal Opportunity Statement

USDM Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Disclaimer

This job description is intended to describe the general nature and the level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. USDM Life Sciences reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

Compensation

Salary/Hourly Rate Range (W2): USD 75.00 - 85.00 per hour.

Full‑time employees are eligible for health, vision, and dental insurance, life insurance, short and long‑term disability, hospital indemnity, accident and critical care coverage. Both full and part‑time employees, who are at least 21 years of age, may participate in USDM's 401(k) plan and may be eligible for paid time off. All employees are eligible for USDM's rewards and recognition program. For more details about our benefits, visit us here:

Seniority Level

Mid‑Senior level

Employment Type

Contract

Job Function

Accounting/Auditing and Finance

Industries

IT Services and IT Consulting

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