Sr. GCP Quality Assurance Auditor

Now Hiring: Senior GCP Quality Assurance Auditor

Location: Hybrid – Paramus, NJ (Onsite Tuesdays, Wednesdays, and Thursdays)

Contract Length: 5–6 Months

Pay Rate: $45–$50/hr (W2)

Schedule: Monday to Friday | 9:00 AM – 5:00 PM

Industry: Biopharmaceutical (Focus: Neurology & Psychiatry)

About the Role

We are seeking a Senior GCP Quality Assurance Auditor to join a dynamic and rapidly growing biopharmaceutical company headquartered in Northern New Jersey. This is a hybrid role requiring onsite presence three days per week. The company specializes in innovative therapies in Neurology and Psychiatry, offering a collaborative environment focused on scientific advancement and patient impact.

This role reports directly to the Director of GCP/PVG Quality Assurance and plays a vital part in maintaining compliance across global clinical development operations. The ideal candidate will have deep expertise in GCP, auditing, and quality systems, with the ability to manage vendor oversight, conduct audits, and support regulatory inspection readiness.

Key Responsibilities

• Conduct internal and external GCP audits (clinical processes, vendors, CROs, CMOs, investigator sites)
• Assess risk and plan targeted clinical vendor and process audits
• Collaborate with SMEs to perform comprehensive vendor audits (IRT, EDC, etc.)
• Draft and distribute audit reports to stakeholders and manage follow-up actions
• Maintain awareness of current GXP regulations and ensure compliance with FDA and international guidelines
• Participate in regulatory inspection preparation and support inspection activities
• Contribute to quality improvement initiatives and cross-functional collaboration

Qualifications

• Bachelor’s degree in a scientific or healthcare-related field
• Minimum of 5 years of pharmaceutical industry experience
• Strong background in GCP and pharmacovigilance auditing
• Hands-on experience conducting internal and external audits
• Solid understanding of SOPs, QMS, and global clinical development standards
• Excellent written and verbal communication skills
• Ability to work cross-functionally with global clinical teams
• Willingness to travel up to 10%

EQUAL EMPLOYMENT OPPORTUNITY STATEMENT:

Suna Solutions provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

Applicants, with criminal histories, are considered in a manner that is consistent with local, state, and federal laws.

REQUESTING AN ACCOMODATION

Suna Solutions is committed to providing equal employment opportunities for persons with disabilities or religious observances, including reasonable accommodation when needed. If you are hired by Suna Solutions and require accommodation to perform the essential functions of your role, you will be asked to participate in our reasonable accommodation process. Accommodations made to facilitate the recruiting process are not a guarantee of future or continued accommodations once hired.

If you would like to be considered for employment opportunities with Suna Solutions and have accommodation needs for a disability or religious observance, please call us at 1 (888) 223-4788, send us an email or speak with your recruiter.

PAY TRANSPARENCY POLICY STATEMENT

Compensation for roles at Suna Solutions varies depending on a wide array of factors including but not limited to the specific client, office or remote location, role, skill set and level of experience. As required by local law, Suna Solutions provides a reasonable pay scale to include the hourly or salary range that Suna Solutions reasonably expects to pay for roles that may be hired in California, Colorado, New York City or Washington.