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Capa Manager Jobs in Hackensack, NJ (NOW HIRING)

Deloitte

System Test and Validation Lead

Jericho, NY · On-site +1

This role supports system validation strategy, audit readiness, CAPA management, and risk-based compliance activities across regulated technology environments. This role helps clients address ...

Deloitte

System Test and Validation Lead

Jericho, NY · On-site +1

This role supports system validation strategy, audit readiness, CAPA management, and risk-based compliance activities across regulated technology environments. This role helps clients address ...

Deloitte

System Test and Validation Lead

New York, NY · On-site +1

This role supports system validation strategy, audit readiness, CAPA management, and risk-based compliance activities across regulated technology environments. This role helps clients address ...

Deloitte

System Test and Validation Lead

New York, NY · On-site +1

This role supports system validation strategy, audit readiness, CAPA management, and risk-based compliance activities across regulated technology environments. This role helps clients address ...

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Capa Manager information

What does a CAPA manager do?

A CAPA (Corrective and Preventive Action) Manager is responsible for overseeing an organization's CAPA process to ensure compliance with quality and regulatory requirements. They investigate quality issues, identify root causes, and implement corrective and preventive measures to prevent recurrence. CAPA Managers work closely with cross-functional teams to improve processes, maintain regulatory compliance, and enhance overall product or service quality.

What are the key skills and qualifications needed to thrive as a CAPA manager?

To thrive as a CAPA Manager (Corrective and Preventive Action Manager), you typically need a background in quality assurance, strong analytical and problem-solving abilities, and experience with regulatory compliance, often supported by a degree in a science or engineering field. Familiarity with quality management systems (QMS), risk management tools, root cause analysis methodologies (such as 5 Whys or Fishbone diagrams), and industry certifications like Six Sigma or ISO 9001 are highly valued. Outstanding candidates demonstrate excellent communication, leadership, and organizational skills to effectively drive cross-functional teams and ensure timely resolution of quality issues. These skills are crucial for identifying, addressing, and preventing compliance gaps or product issues, thereby maintaining high standards and avoiding costly regulatory penalties.

What are some common challenges a CAPA manager faces, and how are they typically addressed?

One common challenge CAPA Managers face is ensuring timely and thorough investigations into quality issues while coordinating input from multiple departments. Balancing the need for fast resolution with the rigor required for regulatory compliance can be demanding, especially in highly regulated industries like pharmaceuticals or medical devices. Successful CAPA Managers often address these challenges through clear process documentation, effective project management, and fostering strong collaboration among stakeholders. By leveraging root cause analysis tools and maintaining open communication, they help create a continuous improvement culture that benefits both the organization and its customers.

What are popular job titles related to Capa Manager jobs in Hackensack, NJ?

For Capa Manager jobs in Hackensack, NJ, the most frequently searched job titles are:

What job categories do people searching Capa Manager jobs in Hackensack, NJ look for?

The top searched job categories for Capa Manager jobs in Hackensack, NJ are:

What cities near Hackensack, NJ are hiring for Capa Manager jobs?

Cities near Hackensack, NJ with the most Capa Manager job openings:

Capa Manager jobs near you
Infographic showing various Capa Manager job openings in Hackensack, NJ as of August 2026, with employment types broken down into 81% Full Time, 17% Part Time, 1% Temporary, and 1% Contract. Highlights an 81% Physical, 2% Hybrid, and 17% Remote job distribution.

QA Product Manager (Sterile Products)

System One

Florham Park, NJ • Remote

$45 - $59/hr

Contractor

Medical, Dental, Vision, Life, Retirement

Re-posted 6 days ago

Job description

Job Title: QA Product Manager (Sterile Products) Location: Florham Park, New Jersey Type: Contract Compensation: $45-$59 per hour dependent on years of experience and education. Contractor Work Model: Hybrid – onsite and remote Hours: 40.0 hours per week

Overview

Responsibilities

  • Review manufacturing and packaging batch records; escalate issues and perform final disposition of assigned products.
  • Support and coordinate investigations (deviations, OOS/OOT, product complaints), initiate CAPAs, and ensure timely closure.
  • Maintain ongoing communication with contract manufacturers to resolve quality issues, monitor compliance, and ensure product release readiness.
  • Provide QA input during regulatory inspections and support documentation needs (change controls, stability protocols, technical agreements).
  • Assist in ensuring that audit findings are tracked and CAPAs are effectively implemented.
  • Collaborate with Supply Chain, Regulatory, and other partners to ensure continued product quality and supply continuity.
  • Lead large-scale technology transfers.
  • Build or negotiate new or existing quality agreements.
  • Provide support for Developmental Products as needed.

Requirements

  • Minimum 4 years of experience of QA experience in sterile drug product manufacturing/oversight.
  • Strong background in batch record review, CAPA management, and sterility assurance.
  • Direct experience with third-party (CMO) oversight.
  • Able to operate independently with minimal supervision.
  • Comfortable working cross-functionally and representing QA in external partner interactions.
  • Experience with quality management software and tools such as Veeva including demonstrated computer experience with MS Word, Excel, and Outlook.
  • Strong knowledge of regulatory requirements and guidelines, such as FDA, EMA, MHRA, PIC/S, ICH, and sterility assurance standards.

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

#M- #LI- #LI-ES1 Ref: #568-Clinical

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About System One

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System One helps employers get work done more efficiently and economically without compromising quality. Over our 35+ year history, we've helped connect thousands of talented people with innovative companies. The excitement of a perfect fit motivates us every single day.

Industry

Business consulting services and recruiting and staffing services

Company size

5,001 - 10,000 Employees

Headquarters location

Pittsburgh, PA, US

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