Sr. GCP Quality Assurance Auditor

Suna Solutions; Paramus (NJ); On-site; USD 90,000 - 130,000; Full time

Job summary

Suna Solutions seeks a Sr. GCP QA Auditor to lead compliance and audit processes in their dynamic biopharma environment, contributing to Neurology and Psychiatry therapies. This role involves ensuring GXP compliance, managing audits, and working collaboratively with cross-functional teams. Ideal candidates will have a background in pharma, strong communication skills, and flexibility for a hybrid schedule.

Qualifications

• 5+ years in pharma with a strong GCP auditing background.
• Proven experience with clinical audits and quality systems.
• Strong communication skills and ability to thrive in fast-paced environments.

Responsibilities

• Lead and conduct global clinical audits (internal & vendor-based).
• Assess compliance with FDA regulations and GCP guidelines.
• Prepare for and support regulatory inspections.

Skills

GCP auditing

Compliance

Communication

Cross-functional collaboration

Education

BS in Science, Healthcare, or related field

Job description

Direct message the job poster from Suna Solutions

Why You Should Join Us:

Be a key player at a rapidly growing biopharma company making waves in Neurology and Psychiatry therapies. This is your chance to make an impact, ensure regulatory compliance, and collaborate with top-tier clinical teams.

What You’ll Be Doing:

As a Sr. GCP QA Auditor, you’ll ensure GXP compliance and support quality systems across internal teams and external partners. You’ll report directly to the Director of GCP/PVG Quality Assurance and help guide the company through internal and external audits, vendor oversight, and regulatory inspections.

• Lead and conduct global clinical audits (internal & vendor-based)
• Assess compliance with FDA regulations, GCP guidelines, and internal SOPs
• Write audit reports, manage non-conformances, and support CAPAs
• Collaborate with cross-functional teams: Clinical Ops, PVG, CMO, CRO
• Prepare for and support regulatory inspections
• Contribute to continuous quality improvement projects
• Occasional travel (~10%) required

What You Bring to the Table:

5+ years in pharma with a strong GCP auditing background

BS in Science, Healthcare, or related field

Proven experience with clinical audits, systems audits, SOPs, and QMS

Strong communication skills and cross-functional collaboration experience

Ability to thrive in a dynamic, fast-paced environment

Flexibility for potential changes in hybrid schedule

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 [phone], 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

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Quality Assurance

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