Lead

Lead

Information Systems

Quality Assurance

$ 60 - $ 64 / Hour

location_onRaritan, New Jersey

acuteContractor

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Your Role

Akkodis is seeking a Lead for a Contract with a client in Raritan, NJ. The ideal candidate with experience leading validation, compliance, and testing activities for regulated systems, ensuring alignment with GxP, FDA, and quality standards.

Rate Range: $60/hour to $64/hour; The rate may be negotiable based on experience, education, geographic location, and other factors.

Lead Job Responsibilities include:

• Lead Computer System Validation (CSV) activities for regulated systems, ensuring compliance with GxP, FDA, and 21 CFR Part 11 requirements.

• Develop, review, and maintain validation documentation, including validation plans, risk assessments, traceability matrices, test protocols, and summary reports.

• Collaborate with business, quality assurance, testing, and technical teams to define validation strategies and support system implementations.

• Coordinate and oversee system testing activities, including System Testing (ST), User Acceptance Testing (UAT), and regression testing to ensure validated system performance.

• Provide validation support throughout the SDLC and STLC lifecycle while managing change controls, compliance reviews, and audit readiness activities.

• Lead stakeholder communications, document reviews, and validation efforts to ensure timely project delivery and adherence to regulatory and quality standards.

Required Qualifications:

• Bachelor's degree in Life Sciences, Computer Science, Information Technology, Engineering, Pharmacy, or a related scientific/technical discipline.

• 6-8 years of experience in Computer System Validation (CSV), Software Validation, Quality Assurance, or Validation activities within regulated environments.

• Strong experience with Computer System Validation (CSV), SDLC/STLC processes, validation documentation, risk assessments, testing protocols, and GxP compliance.

• Proven experience supporting FDA-regulated pharmaceutical environments, including 21 CFR Part 11 compliance, change control management, Agile project validation, and stakeholder coordination.

If you are interested in this role, then please click APPLY NOW. For other opportunities available at Akkodis, or any questions, feel free to contact me at Deep.Kumar@akkodisgroup.com.

Pay Details: $60.00 to $64.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

Military connected talent encouraged to apply

To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.akkodis.com/en/us/candidate-privacy-policy

The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers
• San Francisco Fair Chance Ordinance

Massachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Ref: 1639004

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