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Computer System Validation Manager Jobs in Clementon, NJ

Kenvue

Process Engineer

Flourtown, PA · On-site

Participate in the review and approval process for Computer System Validation documen-tation, such ... Support project management efforts using tools for tracking timelines, risks, issues, and changes ...

Kenvue

Process Engineer

Flourtown, PA

Participate in the review and approval process for Computer System Validation documen-tation, such ... Support project management efforts using tools for tracking timelines, risks, issues, and changes ...

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All JobsComputer System Validation Manager JobsComputer System Validation Manager Jobs in Clementon, NJ

Computer System Validation Manager information

See Clementon, NJ salary details

$48.4K

$107.5K

$163.7K

How much do computer system validation manager jobs pay per year?

As of Jun 25, 2026, the average yearly pay for computer system validation manager in Clementon, NJ is $107,522.00, according to ZipRecruiter salary data. Most workers in this role earn between $76,000.00 and $134,600.00 per year, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a Computer System Validation Manager, and why are they important?

To thrive as a Computer System Validation Manager, you need expertise in computer system validation regulations (such as GxP, FDA 21 CFR Part 11), strong project management skills, and a background in life sciences or IT. Familiarity with validation lifecycle documentation tools, quality management systems (QMS), and compliance software is often required, along with relevant certifications like PMP or CSV-related credentials. Exceptional attention to detail, analytical thinking, and effective communication are crucial soft skills for coordinating cross-functional teams and ensuring regulatory compliance. These skills and qualifications are vital to ensure validated systems meet regulatory standards, minimize compliance risks, and support organizational quality objectives.

What are some common challenges a Computer System Validation Manager faces during system implementation projects?

A Computer System Validation Manager often encounters challenges such as aligning validation activities with evolving regulatory requirements, managing tight project timelines, and coordinating between multiple stakeholders like IT, Quality Assurance, and business users. Ensuring thorough documentation and traceability, while adapting to technology updates or scope changes, can also be demanding. Proactive communication and strong project management skills are essential to mitigate risks and ensure successful, compliant system implementations.

What does a Computer System Validation Manager do?

A Computer System Validation Manager is responsible for ensuring that computer systems used in regulated industries, such as pharmaceuticals or biotechnology, meet all required compliance standards. They oversee the planning, execution, and documentation of validation activities to ensure systems are reliable, accurate, and secure. Their duties include managing validation projects, writing protocols, coordinating with IT and quality assurance teams, and ensuring adherence to regulations like FDA 21 CFR Part 11. This role is critical for maintaining product quality and regulatory compliance.

What is the difference between Computer System Validation Manager vs Computer System Validation Specialist?

AspectComputer System Validation ManagerComputer System Validation Specialist
CertificationsGAMP, CQE, CSQEGAMP, CQE, CSQE
Work EnvironmentManagement, oversight, strategic planningExecution, testing, documentation
Industry UsagePharmaceutical, biotech, regulated industriesPharmaceutical, biotech, regulated industries
Primary FocusLeading validation projects, team coordinationPerforming validation activities, testing

The main difference between a Computer System Validation Manager and a Computer System Validation Specialist lies in their roles. The manager oversees validation projects, manages teams, and ensures compliance, while the specialist executes validation tasks and documents testing procedures. Both roles require similar certifications and are vital in regulated industries like pharmaceuticals and biotech.

What are the most commonly searched types of Computer System Validation jobs in Clementon, NJ? The most popular types of Computer System Validation jobs in Clementon, NJ are:
What job categories do people searching Computer System Validation Manager jobs in Clementon, NJ look for? The top searched job categories for Computer System Validation Manager jobs in Clementon, NJ are:
What cities near Clementon, NJ are hiring for Computer System Validation Manager jobs? Cities near Clementon, NJ with the most Computer System Validation Manager job openings:
Computer System Validation Manager jobs near you
Infographic showing various Computer System Validation Manager job openings in Clementon, NJ as of June 2026, with employment types broken down into 93% Full Time, 4% Part Time, 1% Temporary, 1% Contract, and 1% Nights. Highlights an 92% Physical, 3% Hybrid, and 5% Remote job distribution, with an average salary of $107,522 per year, or $51.7 per hour.
Associate Director, QA Computer System Validation

Associate Director, QA Computer System Validation

Cytokinetics

Radnor, PA • On-site

$184K - $215K/yr

Full-time

Posted 24 days ago

Job description

Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction.
Reporting to the Director, QA Computer System Validation (CSV), the Associate Director, CSV is responsible for compliance oversight of computer system validation projects as part of the quality assurance team. This role will hare strategic responsibility for the QA CSV / CSA function to support cross-functional and QA goals for GXP systems and deliver results for corporate initiatives, as well as independently drive and own multiple complex CSV-related projects in partnership with multiple cross-functional leaders.
Responsibilities:
  • Provide leadership and oversight for implementation of GxP computer system validation lifecycle and related QA-CSV / CSA strategies
  • Actively support the CSV / CSA functional strategies and multi-year roadmap, and actively take part in developing parts of the strategy
  • Lead internal and contract resources to manage CSV / CSA activities and ensure adequate support to meet business needs
  • Participate in global/enterprise wide GxP-CSV / CSA projects and contribute to computer system validation working groups and strategies
  • Manage risk assessments with functional teams to assess system risks and develop mitigations
  • Provide input to CSV / CSA documentation and oversee the execution of qualification/validation activities
  • Review and approve qualification/validation documentation (specifications, protocols, risk assessments, reports)
  • Participate in vendor assessments and/or audits. Manage and/or lead CSV / CSA routine and complex audits including but not limited to internal processes, vendors and business partners
  • Interact regularly with members of QA and other GXP functions to provide expert CSV / CSA compliance guidance, identify issues and support continuous improvement
  • Perform CSV / CSA inspection readiness preparations and/or directly support regulatory agency inspections. Assist in the coordination of response to any findings as applicable
  • Update and/or create computer system related policies, procedures, templates, forms, etc.
  • Provide guidance and expertise on the validation approach in compliance with regulations to project teams as necessary
  • Lead new system selection processes including requirement gathering, RFP development, and software vendor selection
  • Develop and evaluate quality processes and system standards to ensure compliance with applicable procedures, industry standards and global regulations
  • Identify and implement process improvements against industry best practices, regulatory guidelines and requirements
  • Review and approve computer system SOPs, change controls, deviations, and CAPAs

Qualifications:
  • Bachelor's degree in engineering, science or equivalent technical discipline with 10+ years of experience in quality assurance, computer system validation/qualification, or related areas
  • Experience with systems such as Veeva Vault eQMS, Veeva eTMF, CTMS, Medidata Rave, SAS, TraceLink, Oracle Fusion
  • In depth knowledge of CFR 21 Parts 11, GAMP5, Annex 11 and data integrity requirements, standards and guidelines
  • Strong background and understanding of EMA, MHRA, FDA and other regulations
  • In depth knowledge of Good Clinical practice (GCP), Good pharmacovigilance Practice (GVP), Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and Good Laboratory Practices (GLP)
  • Detail-oriented, well organized, and able to assume responsibility for multiple projects independently
  • Experience in authoring/reviewing/approving validation documentation
  • In depth knowledge of software development lifecycle (SDLC) model
  • Knowledge in validation practices of various computerized systems (configurable software, non-configurable software, off-the-shelf software)
  • Data migration experience
  • Experience with vendor audits
  • Ability to work in a collaborative team environment is essential, with a customer focused approach
  • Strong decision maker with the ability to utilize critical thinking to problem-solve
  • Must have strong interpersonal and communication skills, and the ability to work with multiple cross-functional teams
    #LI-HYBRID

Pay Range:
In the U.S., the hiring pay range for fully qualified candidates is $184,500 - $215,250 per year. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors.
Our employees come from different backgrounds, and we celebrate those differences. We are looking for the best candidates for our open roles, but do not expect applicants to meet every qualification in order to be considered. If you are excited about what you could accomplish at Cytokinetics and believe you can add value to our team, we would love to hear from you.
Please review our General Data Protection Regulation (GDPR) policy PRIOR to applying.
Our passion is anchored in robust scientific thinking, grounded in integrity and critical thinking. We keep the patient front and center in all we do - all actions and decisions are in service of the patient and their caregivers. We champion integrity, ethics, doing the right thing, and being our best selves.
Fraud Warning: How to Identify Impersonated Cytokinetics Job Postings and Offers
Recently, there have been fraudulent employment offers being sent to candidates on behalf of Cytokinetics. Please be advised that all legitimate offers from Cytokinetics will come directly from our official email domain (Cytokinetics.com) and will only be made after completing a formal interview process.
Here are some ways to check for authenticity:
  • We do not conduct job interviews through non-standard text messaging applications
  • We will never request personal information such as banking details until after an official offer has been accepted and verified
  • We will never request that you purchase equipment or other items when interviewing or hiring
  • If you are unsure about the authenticity of an offer, or if you receive any suspicious communication, please contact us directly at talentacquisition@cytokinetics.com

Please visit our website at: www.cytokinetics.com
Cytokinetics is an Equal Opportunity Employer

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