Review audit responses/CAPA(s) for acceptability and escalate issues in accordance with applicable ... Position is 100% remote. Minimum Requirements: Bachelor's degree in Regulatory Affairs, Health ...
Review audit responses/CAPA(s) for acceptability and escalate issues in accordance with applicable ... Position is 100% remote. Minimum Requirements: Bachelor's degree in Regulatory Affairs, Health ...
Job Title: Quality Control Technician (Quality Engineer - Contract) Location: 100% Remote ... Participate in FMEA, RCA, and CAPA development activities * Ensure corrective and preventive ...
Quick apply
Job Title: Quality Control Technician (Quality Engineer - Contract) Location: 100% Remote ... Participate in FMEA, RCA, and CAPA development activities * Ensure corrective and preventive ...
Vice President, Head of Clinical Operations
New York, NY · Remote
$303K - $364K/yr
... CAPA management, and proactive issue resolution The Team You'll Join You will join Recursion ... This is a fully remote opportunity with occasional travel requirements. Travel may be necessary ...
Vice President, Head of Clinical Operations
New York, NY · Remote
$303K - $364K/yr
... CAPA management, and proactive issue resolution The Team You'll Join You will join Recursion ... This is a fully remote opportunity with occasional travel requirements. Travel may be necessary ...
Supports the maintenance and upkeep of the Quality Management System. Maintains the Quality ... This role is fully remote to those in/willing to relocate to Maryland, Virginia, or Washington D.C.
Supports the maintenance and upkeep of the Quality Management System. Maintains the Quality ... This role is fully remote to those in/willing to relocate to Maryland, Virginia, or Washington D.C.
Coordinate with cross-functional teams to support compliance-related activities, including client audits, CAPA management, procedural documentation, and quality initiatives. * Lead smaller projects ...
Coordinate with cross-functional teams to support compliance-related activities, including client audits, CAPA management, procedural documentation, and quality initiatives. * Lead smaller projects ...
Director, Quality Systems & Regulatory Affairs (Remote - East Coast)
Darien, CT · On-site +1
$160K - $180K/yr
Remote or Hybrid - East Coast ONLY FLSA Status: Exempt, Full-Time Position Summary CEFALY ... Support and improve CAPA, nonconformance, complaint handling, change control, risk management, and ...
Director, Quality Systems & Regulatory Affairs (Remote - East Coast)
Darien, CT · On-site +1
$160K - $180K/yr
Remote or Hybrid - East Coast ONLY FLSA Status: Exempt, Full-Time Position Summary CEFALY ... Support and improve CAPA, nonconformance, complaint handling, change control, risk management, and ...
Director, Quality Systems & Regulatory Affairs (Remote - East Coast)
Darien, CT · On-site +1
$160K - $180K/yr
Remote or Hybrid - East Coast ONLY FLSA Status: Exempt, Full-Time Position Summary CEFALY ... Support and improve CAPA, nonconformance, complaint handling, change control, risk management, and ...
Director, Quality Systems & Regulatory Affairs (Remote - East Coast)
Darien, CT · On-site +1
$160K - $180K/yr
Remote or Hybrid - East Coast ONLY FLSA Status: Exempt, Full-Time Position Summary CEFALY ... Support and improve CAPA, nonconformance, complaint handling, change control, risk management, and ...
Coordinate with cross-functional teams to support compliance-related activities, including client audits, CAPA management, procedural documentation, and quality initiatives. * Lead smaller projects ...
Coordinate with cross-functional teams to support compliance-related activities, including client audits, CAPA management, procedural documentation, and quality initiatives. * Lead smaller projects ...
Director, Quality Systems & Regulatory Affairs (Remote - East Coast)
Darien, CT · Remote
$160K - $180K/yr
Remote or Hybrid - East Coast ONLY FLSA Status: Exempt, Full-Time Position Summary CEFALY ... Support and improve CAPA, nonconformance, complaint handling, change control, risk management, and ...
Quick apply
Director, Quality Systems & Regulatory Affairs (Remote - East Coast)
Darien, CT · Remote
$160K - $180K/yr
Remote or Hybrid - East Coast ONLY FLSA Status: Exempt, Full-Time Position Summary CEFALY ... Support and improve CAPA, nonconformance, complaint handling, change control, risk management, and ...
Senior Document Control Coordinator
Cary, IL · Remote
$23 - $28.25/hr
Hybrid - onsite and remote Hours: 40.0 Overview Leading medical device company looking for an ... As well as, working knowledge of quality system processes (Change Control, CAPA, Nonconformance ...
Quick apply
Senior Document Control Coordinator
Cary, IL · Remote
$23 - $28.25/hr
Hybrid - onsite and remote Hours: 40.0 Overview Leading medical device company looking for an ... As well as, working knowledge of quality system processes (Change Control, CAPA, Nonconformance ...
Senior Document Control Coordinator
Cary, IL · Remote
$23 - $28.25/hr
Hybrid - onsite and remote Hours: 40.0 Overview Leading medical device company looking for an ... As well as, working knowledge of quality system processes (Change Control, CAPA, Nonconformance ...
Quick apply
Senior Document Control Coordinator
Cary, IL · Remote
$23 - $28.25/hr
Hybrid - onsite and remote Hours: 40.0 Overview Leading medical device company looking for an ... As well as, working knowledge of quality system processes (Change Control, CAPA, Nonconformance ...
Senior Document Control Coordinator
Cary, IL · Remote
$23 - $28.25/hr
Hybrid - onsite and remote Hours: 40.0 Overview Leading medical device company looking for an ... As well as, working knowledge of quality system processes (Change Control, CAPA, Nonconformance ...
Quick apply
Senior Document Control Coordinator
Cary, IL · Remote
$23 - $28.25/hr
Hybrid - onsite and remote Hours: 40.0 Overview Leading medical device company looking for an ... As well as, working knowledge of quality system processes (Change Control, CAPA, Nonconformance ...
Senior Document Control Coordinator
Cary, IL · Remote
$23 - $28.25/hr
Hybrid - onsite and remote Hours: 40.0 Overview Leading medical device company looking for an ... As well as, working knowledge of quality system processes (Change Control, CAPA, Nonconformance ...
Quick apply
Senior Document Control Coordinator
Cary, IL · Remote
$23 - $28.25/hr
Hybrid - onsite and remote Hours: 40.0 Overview Leading medical device company looking for an ... As well as, working knowledge of quality system processes (Change Control, CAPA, Nonconformance ...
Senior Document Control Coordinator
Cary, IL · Remote
$23 - $28.25/hr
Hybrid - onsite and remote Hours: 40.0 Overview Leading medical device company looking for an ... As well as, working knowledge of quality system processes (Change Control, CAPA, Nonconformance ...
Quick apply
Senior Document Control Coordinator
Cary, IL · Remote
$23 - $28.25/hr
Hybrid - onsite and remote Hours: 40.0 Overview Leading medical device company looking for an ... As well as, working knowledge of quality system processes (Change Control, CAPA, Nonconformance ...
Senior Document Control Coordinator
Cary, IL · Remote
$23 - $28.25/hr
Hybrid - onsite and remote Hours: 40.0 Overview Leading medical device company looking for an ... As well as, working knowledge of quality system processes (Change Control, CAPA, Nonconformance ...
Quick apply
Senior Document Control Coordinator
Cary, IL · Remote
$23 - $28.25/hr
Hybrid - onsite and remote Hours: 40.0 Overview Leading medical device company looking for an ... As well as, working knowledge of quality system processes (Change Control, CAPA, Nonconformance ...
Senior Document Control Coordinator
Cary, IL · Remote
$23 - $28.25/hr
Hybrid - onsite and remote Hours: 40.0 Overview Leading medical device company looking for an ... As well as, working knowledge of quality system processes (Change Control, CAPA, Nonconformance ...
Quick apply
Senior Document Control Coordinator
Cary, IL · Remote
$23 - $28.25/hr
Hybrid - onsite and remote Hours: 40.0 Overview Leading medical device company looking for an ... As well as, working knowledge of quality system processes (Change Control, CAPA, Nonconformance ...
Senior Document Control Coordinator
Cary, IL · Remote
$23 - $28.25/hr
Hybrid - onsite and remote Hours: 40.0 Overview Leading medical device company looking for an ... As well as, working knowledge of quality system processes (Change Control, CAPA, Nonconformance ...
Quick apply
Senior Document Control Coordinator
Cary, IL · Remote
$23 - $28.25/hr
Hybrid - onsite and remote Hours: 40.0 Overview Leading medical device company looking for an ... As well as, working knowledge of quality system processes (Change Control, CAPA, Nonconformance ...
Senior Document Control Coordinator
Cary, IL · Remote
$23 - $28.25/hr
Hybrid - onsite and remote Hours: 40.0 Overview Leading medical device company looking for an ... As well as, working knowledge of quality system processes (Change Control, CAPA, Nonconformance ...
Quick apply
Senior Document Control Coordinator
Cary, IL · Remote
$23 - $28.25/hr
Hybrid - onsite and remote Hours: 40.0 Overview Leading medical device company looking for an ... As well as, working knowledge of quality system processes (Change Control, CAPA, Nonconformance ...
... operational management platforms. * Develop standards, metrics, reporting frameworks, and ... Support investigations, root cause analyses, and Corrective and Preventive Action (CAPA) activities.
New
... operational management platforms. * Develop standards, metrics, reporting frameworks, and ... Support investigations, root cause analyses, and Corrective and Preventive Action (CAPA) activities.
New
Director, Remote Research Clinicians
Durham, NC · On-site +1
... operational management platforms. * Develop standards, metrics, reporting frameworks, and ... Support investigations, root cause analyses, and Corrective and Preventive Action (CAPA) activities.
New
Director, Remote Research Clinicians
Durham, NC · On-site +1
... operational management platforms. * Develop standards, metrics, reporting frameworks, and ... Support investigations, root cause analyses, and Corrective and Preventive Action (CAPA) activities.
New
Remote Capa Manager information
What is the difference between Remote Capa Manager vs Remote Capacity Planner?
| Aspect | Remote Capa Manager | Remote Capacity Planner |
|---|---|---|
| Primary Focus | Oversees overall capacity management, resource allocation, and operational efficiency | Analyzes and forecasts capacity needs to meet production or service demands |
| Key Responsibilities | Strategic planning, team coordination, capacity optimization | Data analysis, demand forecasting, capacity modeling |
| Required Skills | Project management, leadership, communication | Analytical skills, data analysis, forecasting tools |
| Work Environment | Remote, cross-functional teams, management level | Remote, analytical teams, planning departments |
While both roles focus on capacity, the Remote Capa Manager manages overall capacity strategies and team coordination, whereas the Remote Capacity Planner concentrates on analyzing data and forecasting future capacity needs. The manager role is more strategic and leadership-oriented, while the planner role is more analytical and data-driven.
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$217K/yr
Full-time
This job post has expired 1 day ago. Applications are no longer accepted.
American Regent rating
7.2
Based on 12 frontline employees who took The Breakroom Quiz
60th of 74 rated pharmaceutical
Job description
- Manage the CQA activities associated with the development of study-specific audit plans and oversight of clinical quality assurance processes that contribute to the quality oversight of functions including Pharmacovigilance, Clinical Operations, Quantitative Sciences, and Regulatory Affairs.
- Evaluate compliance with all applicable government regulations, federal guidelines, company Standard Operating Procedures, and industry standards.
- Support the Head of Clinical Quality Assurance to ensure implementation and continuous improvement of all CQA processes.
- Lead quality oversight of assigned animal and/or human clinical study programs including independent planning and execution of audits according to developed study-specific audit plans
to assure adherence to company Standard Operating Procedures and other specified standards, and any applicable regulatory requirements.
- Lead quality oversight of post-marketing Pharmacovigilance activities for human and animal products.
- Develop, plan, schedule, and conduct audits of clinical investigator sites, trial master files, systems/process, clinical study documents, clinical research and Pharmacovigilance vendors.
- Generate and issue audit reports to summarize results of conducted audits in accordance with company Standard Operating Procedures.
- Provide audit-related feedback to stakeholders.
- Review audit responses/CAPA(s) for acceptability and escalate issues in accordance with applicable company Standard Operating Procedures.
- Review, approve, and track CAPA completion in accordance with company Standard Operating Procedures.
- Close audit reports and file reports and associated documentation in accordance with company Standard Operating Procedures.
- Review and approve deviations to internal processes reported by Pharmacovigilance, Clinical Operations, Quantitative Sciences, and Regulatory Affairs.
- Lead process improvement activities to support inspection preparation/readiness activities.
- Lead key activities during regulatory inspections and/or external audits as directed.
- Provide management with support for continuous improvement activities.
- Lead the development and maintenance departmental Standard Operating Procedures and other Standards.
- Provide onboarding support to new CQA team members and mentoring as needed.
- Provide training to staff and on applicable regulations and guidelines including Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Pharmacovigilance (GVP).
- Provide independent regulatory requirement/compliance advice to Pharmacovigilance, Clinical Operations, Quantitative Sciences, and Regulatory Affairs functions.
Position is 100% remote.
Minimum Requirements:
Bachelor's degree in Regulatory Affairs, Health Administration, Pharmaceutical Science or a related field or foreign equivalent, plus five (5) years of experience working in a pharmaceutical, biotechnology, or healthcare environment. In addition, five (5) years of experience with the following is required:
- Experience in the management of CQA activities including system/process-related auditing;
- Investigator site, CRO, IRB, and Pharmacovigilance auditing experience;
- Medicinal product development and global clinical regulatory environment in pharmaceuticals or biotechnology environment including 21 CFR Part 11, 21 CFR 312, 21 CFR 314, EU
Directives, Health Canada Regulations, and ICH E6 (R2); and
- Utilizing Quality Management Systems.
Position is 100% remote.
Salary: $217,422.00 per year
Please apply at https://www.americanregent.com/Careers using Req. ID 103297.
American Regent celebrates diversity, and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
American Regent Inc. endeavors to make https://americanregent.com/Careers accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact John Rossini, Talent Acquisition Director at jrossini@americanregent.com.
American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.
Applicants have rights under Federal Employment Laws.
- FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf
- Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov)
- Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf
Alert: We're aware of individuals impersonating our staff to target job seekers. Please note:
• All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address.
• Our recruiting process includes multiple in person and/or video interviews and assessments.
• If you are unsure about the legitimacy of a message, contact John Rossini at jrossini@americanregent.com before responding.
• We never request payment, bank information, or personal financial details during our offer process.
Your security is important to us, and we encourage you to stay vigilant when job searching.
American Regent Inc. endeavors to make https://careers.americanregent.com/ accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email hrtalentacquisition@americanregent.com.
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About American Regent
Sourced by ZipRecruiter
Industry
Pharmaceutical and medicine manufacturing
Company size
501 - 1,000 Employees
Headquarters location
Shirley, NY, US
Year founded
1910