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Capa Manager Jobs in Paterson, NJ (NOW HIRING)

Getinge

Sr. Manager, R&D Product Excellence

Wayne, NJ

$125K - $165K/yr

R&D CAPA Management * Lead the CAPA process to ensure effective identification, investigation, correction, and prevention of quality issues. * Ensure robust root cause investigations utilizing ...

Getinge

Sr. Manager, R&D Product Excellence

Wayne, NJ · On-site

$125K - $165K/yr

R&D CAPA Management * Lead the CAPA process to ensure effective identification, investigation, correction, and prevention of quality issues. * Ensure robust root cause investigations utilizing ...

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

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

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

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

Capa Manager jobs near you
Infographic showing various Capa Manager job openings in Paterson, NJ as of August 2026, with employment types broken down into 87% Full Time, 11% Part Time, and 2% Contract. Highlights an 80% Physical, 3% Hybrid, and 17% Remote job distribution.

Manager, R&D Quality Audits, Inspections and CAPA

Kite Pharma

Parsippany, NJ

Full-time

Medical, Dental, Vision, Life, PTO

Posted 24 days ago

Job description

We're here for one reason and one reason only - to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We've made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.

Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.


Job Description

As the Manager, R&D Quality Audits, Inspections and CAPA, you will serve as a primary quality and compliance partner for assigned Kite R&D groups, studies,projectsand locations. This role supports GCP and GVP quality oversight, internal and investigator site audit execution, inspection readiness, vendor auditawarenessand CAPA management. You will partner cross-functionally with Kite stakeholders and Gilead RDQ teams to help ensure R&D activitiesremaincompliant with applicable regulations, Kite's Quality Management System, internalpoliciesand established procedures.

Key Responsibilities

  • Serve as a primary quality partner for assigned R&D GCP and GVP teams, providing guidance on regulatory expectations, Kite quality requirements, internal procedures, inspectionreadinessand CAPA development.

  • Lead or support internal R&D quality audits for assigned groups, processes, vendors or locations, including GCP-focused activities, investigator site audits, internal processauditsand GVP-related audits as assigned.

  • Support vendor audit awareness and compliance oversight by partnering with cross-functional teams to understand vendor qualifications, performance trends, auditneedsand study-level compliance risks.

  • Develop, track and support effective CAPAs in partnership with cross-functional stakeholders to address audit findings, inspection observations, deviations, qualityeventsand other compliance risks.

  • Supportinspectionreadiness activities, including preparation, coordination, responsesupportand follow-up actions for regulatory or compliance inspections.

  • Evaluate SOPs, procedures, data,documentationand reporting for assigned R&D groups to help ensure regulatory compliance, qualityoversightand alignment with business needs.

  • Oversee or coordinate contract auditor activities, including auditor engagement, work direction, documentationreviewand audit deliverable follow-up.

  • Advise teams on quality systems, processes, documentation,trainingand CAPA management to support consistent R&D quality practices.

  • Develop and deliver GCP and GVP-focused training for assigned R&D groups and stakeholders.

  • Lead orparticipatein continuous improvement initiatives related to R&D audits, inspections, CAPA processes, quality systems, policies,proceduresand tools.

  • Support quality metrics, reporting and communications related to audit plans, audit outcomes, inspection readiness, CAPAstatusand quality trends.

  • May support task management, workloadcoordinationor day-to-day guidance for other team members without direct people management responsibility.

  • Promote a culture of quality, accountability,collaborationand inspection readiness across Kite R&D and with external partners and vendors.

  • Ensure assigned work is completedin accordance withapplicable regulations,establishedpractices, policies,proceduresand business processes.

Basic Qualifications

  • PharmD or PhD with relevant quality and compliance experience; or

  • MA,MSor MBA with 4+ years of quality and compliance experience; or

  • BA or BS with 6+ years of quality and compliance experience.

Preferred Qualifications

  • MA,MSor MBA with 4+ years of relevant quality and compliance experience preferred.

  • Strong GCP auditing experience, including experience serving as lead auditor for investigator site audits.

  • Experience supporting or leading internal process audits within GCP, R&D quality, clinicaloperationsor related biopharma functions.

  • Experience supporting inspection readiness, inspection preparation, inspection responseactivitiesor inspection follow-up actions.

  • Vendor audit experience or strong working knowledge of vendor qualifications, vendor performance oversight and study-level vendor compliance expectations.

  • Quality, compliance, regulatory or related experience supporting pharmacovigilance, safety, medical affairs, clinicaloperationsor other R&D functions, with strong experience in GCP and GVP.

  • Internal auditing and CAPA development experience within GCP, GVP, pharmacovigilance,safetyor related biopharma functions.

  • Experience leading quality,complianceor related projects in the biopharma industry, including process improvements, system enhancements, SOPupdatesor quality initiatives.

  • Experience working with GCP and GVP processes,systemsand quality expectations in a biopharma or related environment.

  • Experience with total quality management methodologies, such as Lean Six Sigma.

  • Experience supporting one or more Kite therapeutic areas and multiple stages of drug development.

  • Quality Auditor certification or similar quality-related certification.

Knowledge and Other Requirements

  • Strong knowledge of Good Clinical Practices, Good Pharmacovigilance Practices, quality systems, safety reporting, inspectionreadinessand CAPA management.

  • Working knowledge of Good Clinical Laboratory Practices and Electronic Systems Compliance.

  • Ability to apply sound judgment and flexibility in GCP quality environments where risk evaluation may besituation-specific.

  • Strong analytical thinking, attention to detail, writtencommunicationand project management skills.

  • Ability to recognize urgency, escalate key quality or inspection-related issues appropriately and adapt priorities when inspection or compliance activities require immediate attention.

  • Ability to learn quickly, adapt to changingprioritiesand support multiple projects or business needs.

  • Ability to lead, influence and collaborate across programs,projectsand cross-functional initiatives without direct authority.

  • Strong interpersonal skills and ability to work effectively in a highly matrixed, team-oriented environment with Kite and Gilead partners.

  • Transparency, flexibility,accountabilityandstrong communicationskills.

  • Proficiencywith Microsoft Office applications.

  • Ability to travel globally as needed, estimated atapproximately 30%to 40% depending on audit schedules, siteavailabilityand business needs.


The salary range for this position is:

Bay Area: $136,340.00 - $176,440.00.


Other US Locations: $123,930.00 - $160,380.00.


Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.


Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.

For jobs in the United States:

Kite Pharma is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability,genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contactApplicantAccommodations@gilead.com for assistance.


For more information about equal employment opportunity protections, please view the'Know Your Rights' poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT


Kite Pharma will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.


Kite Pharma provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Kite Pharma Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.

Apply