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

Job Title: GCP Auditor/Senior Auditor, Quality Assurance

The GCP Quality Assurance Auditor/Senior Auditor will play a crucial role in ensuring compliance with regulatory authorities by driving and implementing the company's compliance directives. This position supports quality management systems to minimize risks in a regulated pharmaceutical environment. The incumbent will conduct both internal and external GXP audits and provide day-to-day support to the GXP QA Director in clinical operations, non-clinical, and manufacturing processes. This role requires managing CROs, CMOs, investigator sites, and vendors to support clinical trials in a rapidly growing biopharmaceutical company specializing in Neurology and Psychiatry therapies.

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 alongside various SMEs to 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.
• 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.

Essential Skills

• 5 years of pharmaceutical experience.
• BS degree in scientific, health care, or related discipline.
• Extensive GCP experience.
• Experience with both internal and external process and systems audits.
• Strong knowledge of development policies, procedures, and standards.
• Ability to work with global clinical teams in developing objectives for audits of clinical studies.
• 10% traveling required.

Additional Skills & Qualifications

• Sponsor experience, not only CRO experience.
• 5 years of experience with GCP, TMF audits, system audits, inspection readiness, and CRO audits.
• 2 years of experience in independent auditing.
• Phase 2 and 3 clinical trial experience is desirable.

Work Environment

This position requires a minimum of three days in the office, specifically from Tuesday to Thursday. The team consists of four members, including one GCP auditor and one PV auditor. The company is based in Northern New Jersey and requires on-site presence.

This is a Contract to Hire position based out of Paramus, NJ.

The pay range for this position is $64.00 - $68.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

This is a hybrid position in Paramus,NJ.

This position is anticipated to close on Dec 30, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $64 - $68