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Capa Manager Jobs in Raleigh, NC (NOW HIRING)

Pentair

Quality Management Systems (QMS) Manager

Apex, NC · On-site

$95K - $177K/yr

Reporting to the Director of Quality-Pool, the QMS Manager partners closely with cross-functional ... Lead the Corrective and Preventive Action process (CAPA). * Facilitate root cause analysis using ...

Pentair

Quality Management Systems (QMS) Manager

Apex, NC · On-site

$95K - $177K/yr

Reporting to the Director of Quality-Pool, the QMS Manager partners closely with cross-functional ... Lead the Corrective and Preventive Action process (CAPA). * Facilitate root cause analysis using ...

New

Pentair

Quality Management Systems (QMS) Manager

Apex, NC · On-site

$95K - $177K/yr

Reporting to the Director of Quality-Pool, the QMS Manager partners closely with cross-functional ... Lead the Corrective and Preventive Action process (CAPA). * Facilitate root cause analysis using ...

Pentair

Quality Management Systems (QMS) Manager

Apex, NC · On-site

$95K - $177K/yr

Reporting to the Director of Quality-Pool, the QMS Manager partners closely with cross-functional ... Lead the Corrective and Preventive Action process (CAPA). * Facilitate root cause analysis using ...

New

PowerSecure

Production Manager

Durham, NC · On-site

Manages multiple work centers and manufacturing disciplines, monitoring performance and reinforcing ... Apply corrective and preventive action (CAPA) best practices to address quality, delivery, and ...

PowerSecure, Inc.

Production Manager

Durham, NC

Manages multiple work centers and manufacturing disciplines, monitoring performance and reinforcing ... Apply corrective and preventive action (CAPA) best practices to address quality, delivery, and ...

PowerSecure

Production Manager

Durham, NC · On-site

Manages multiple work centers and manufacturing disciplines, monitoring performance and reinforcing ... Apply corrective and preventive action (CAPA) best practices to address quality, delivery, and ...

PowerSecure Brand

Production Manager

Durham, NC · On-site

Manages multiple work centers and manufacturing disciplines, monitoring performance and reinforcing ... Applies corrective and preventive action (CAPA) best practices to address quality, delivery, and ...

Alcon

Manager, Good Clinical Practices

Durham, NC · On-site

You will manage external audits, ensure site preparedness, and coordinate Corrective and Preventive Action (CAPA) processes. As a Manager, Good Clinical Practices supporting the QA Compliance Team in ...

UPL Limited

Quality Engineer (Chemical)

Cary, NC · On-site

$66K - $86K/yr

This role oversees quality management systems (QMS), product compliance, investigation of quality issues, implementation of corrective and preventive actions (CAPA), and continuous improvement ...

DivIHN

QA Contractor, GMP Quality Assurance

NC · On-site

Draft SOPs/controlled documents as well as perform quality unit review and approval of Quality Management Systems requests/ records related to Learning Management, Non-Conformance Management, CAPA ...

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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.

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For Capa Manager jobs in Raleigh, NC, the most frequently searched job titles are:

What job categories do people searching Capa Manager jobs in Raleigh, NC look for?

The top searched job categories for Capa Manager jobs in Raleigh, NC are:

What cities near Raleigh, NC are hiring for Capa Manager jobs?

Cities near Raleigh, NC with the most Capa Manager job openings:

Capa Manager jobs near you
Infographic showing various Capa Manager job openings in Raleigh, NC as of August 2026, with employment types broken down into 88% Full Time, 10% Part Time, and 2% Contract. Highlights an 79% Physical, 2% Hybrid, and 19% Remote job distribution.

Manager, Audit Compliance

Durham, NC • On-site

Alcami Corporation
Pharmaceutical and Medicine Manufacturing • 501 - 1,000 employees
Learn more about Alcami Corporationexternal

Full-time

Re-posted 4 days ago

Alcami rating

7.8

Company rating: 7.8 out of 10

Based on 9 frontline employees who took The Breakroom Quiz

Job description

At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record.
Are you interested in joining our team?
Job Summary
The Manager, Audit Compliance is accountable for driving results in a fast-paced environment, continuously challenging performance in regard to quality standards, systems, and operating procedures. Responsibilities include oversight of client audit response and associated team. This position will be performing activities of substantial variety to ensure quality and compliance with applicable regulatory requirements. Activities include reviewing documents and data, CAPAs, Change Control, supporting audits and inspections, consulting on quality and compliance issues, and performing trend analysis where needed, and performing quality and compliance training as needed. The position develops SOPs or other quality documents as needed.
The Manager, Audit Compliance will ensure the audit team members partner with audit hosts and serve as subject matter experts, supporting tours when appropriate, responding to real-time Q&A, and providing documentation for audit requests. This position ensures responses align across sites, ensures appropriate CAPAs are in place, and submit responses to clients on time. This position ensures there is review of client audit trends, recurring observations, response cycle time, and CAPA effectiveness to drive continuous improvement. This position may also support client audit hosting activities, internal audits, and regulatory inspections.
On-Site Expectations
  • 100% on-site position.
  • 1st Shift: Monday - Friday, 8:00am - 5:00pm.

Responsibilities
  • Represents the department in meetings, collaborates, and cooperates to achieve cross-functional improvements and business goals.
  • Creates departmental systems and fosters a culture of continuous improvement focused on value to the customer.
  • Manages the day-to-day operations for assigned area.
  • Ensures all staff members are fully trained.
  • Performs quality review and approval and authoring of complex documents, all types of data, audit responses, CAPA, change controls, etc.
  • Collaborates with site Operations and Technical leadership to ensure timely closure of items associated with audits including observation responses, corrective actions, and other Quality documents.
  • Supports for client and regulatory agency audits and inspections to ensure minimal observations.
  • Assists in driving on-time site responses to regulatory and client audit reports.
  • Participates in and supports client visits, audits, and inquiries to ensure complete fulfillment of requests and interests.
  • Recruits, trains, develops, and retains staff for the effective process of departmental operations.
  • Provides technical guidance for troubleshooting and investigating simple to complex issues in area of expertise.
  • Effectively resolves quality issues and concerns in a timely manner.
  • Creates strong and effective relationships with clients.
  • Other duties as assigned.

Qualifications
  • B.S./B.A./M.S. in a related field with 10+ years relevant experience or equivalent.
  • Relevant Leadership and GMP experience required.
  • Strong knowledge in any of the following areas needed to support audits is preferred: Sterile Manufacturing, Oral Solid Dose Manufacturing, Packaging, Warehouse and supply chain, Chemistry Laboratory (large and small molecule), or Microbiology.

Knowledge, Skills, and Abilities
  • Strong technical skills for area managing.
  • Expert knowledge of pharmaceutical regulatory requirements and cGMP required.
  • Knowledge of quality systems and processes, change control, and CAPA required.
  • Strong Knowledge of auditing preferred.
  • Excellent skills in leadership, coaching and influencing others, critical thinking and problem solving, root-cause analysis and written communication and presentation skills required.
  • Good business acumen.
  • Strong understanding of company SOPs, and regulatory guidance documents.
  • Strong knowledge of safety procedures and quality compliance for assigned area.
  • Strong attention to detail, as well as time and resource management.
  • Strong personnel and professional integrity and trustworthiness with strong work ethics and the ability to work independently with some direction.
  • Promote a safe environment for work.
  • Comply with the general policy of the company.
  • High level of personnel and professional integrity and trustworthiness with strong work ethics and the ability to work independently with minimal direction.
  • Ability to develop and manage a high-performance team focused on quality, accountability and meeting and exceeding expectations.
  • Communicate well orally both for internal customers and team members as well as external customers.
  • Ability to write reports and business correspondences.
  • Ability to listen and respond well to external customers, partners and colleagues at all levels.
  • Highly goal and result oriented.
  • Prioritizes tasks according to business objectives and can pursue several objectives simultaneously.
  • Can work independently with a high degree of self-motivation.
  • Knows how to obtain support from different collaborations.
  • Tackles problems with enthusiasm and curiosity.
  • Treats colleagues at all levels with respect.
  • Very effective listening skills with the ability to hear attentively and process information correctly.

Travel Expectations
  • Up to 10% travel expected.

Physical Demands and Work Environment
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee may be required to use hands to finger, handle, or feel and to reach with hands and arms. The employee is required to talk and hear. The employee is frequently required to stand, walk and sit. The employee may be occasionally required to climb or balance. The employee may be required to regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, and peripheral vision.
While performing the duties of this job, the employee may be occasionally exposed to moving mechanical parts, high precarious places and vibration. The noise level in the work environment is usually quiet. The employee may be required to gain access to lab, manufacturing or clinical areas for inspections or work discussions. The employee is required to wear the appropriate personal protective equipment to perform the job duties. Such personal protective equipment may include but is not limited to safety eyewear, various types of respirators/breathing apparatus, lab coats, gloves, etc.

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