- Actalent (Parsippany, NJ)
- …Preferred Qualifications + Prior experience in Quality Assurance or Compliance roles. + Familiarity with FDA -regulated operations and regulatory ... We are seeking a detail-oriented and experienced Technical Writer - Compliance to join our Quality or Manufacturing team. In this role, you will be responsible… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- Description: The Manager, Field Alert & Recall Compliance is responsible for overseeing regulatory activities related to Field Alert Reports (FARs), product recalls, ... and market withdrawals, including investigation management, FDA notification, and effectiveness monitoring. This role leads site-wide and cross-departmental… more
- embecta (Parsippany, NJ)
- …standards and regulatory requirements, including FDA and ISO standards. The Quality Compliance Auditor plays a strategic role in maintaining embecta's ... varying needs of our diverse and global employees. The Quality Compliance Auditor is a critical role...the Quality Management System (QMS) to ensure compliance with FDA regulations, ISO 13485, ISO… more
- Merck (Trenton, NJ)
- …or a related field. + 10+ years of progressive experience in Quality Compliance , preferably within large molecule manufacturing (biologics and/or vaccines). ... **Job Description** We are seeking a dynamic and experienced Quality & Compliance Director to lead GMP...Deep expertise in GMP requirements across multiple regulatory agencies ( FDA , EU, ROW) + Strong understanding of different pharmaceutical… more
- RWJBarnabas Health (West Orange, NJ)
- …academic and industry partners. The successful candidate will bring deep expertise in FDA regulations, IRB processes, HIPAA compliance in research, and federal ... years of legal experience, including substantial experience with clinical research, FDA regulatory compliance , and research contracting + Comprehensive knowledge… more
- Integra LifeSciences (Plainsboro, NJ)
- …treatment pathways to advance patient outcomes and set new standards of care. The ** Quality Compliance Specialist** will provide quality compliance ... Quality Management Reviews + Serve as the quality compliance representative for project teams +...and internal Standard Operating Procedures + Provide support in FDA inspections, ISO audits and customer audits at the… more
- Honeywell (Hamilton, NJ)
- …execution and recipe management, quality management systems, regulatory compliance (GMP, FDA , EMA), manufacturing analytics, digital transformation ... in addressing critical challenges including technology transfer, batch execution, quality management, regulatory compliance , and operational efficiency. **Key… more
- BeOne Medicines (Pennington, NJ)
- …include some travel. **_Essential Functions of the job_** **_:_** + Within the Quality Assurance organization, develop and implement Compliance programs for the ... + Minimum of 8 years of experience in quality assurance and/or quality control in an FDA -regulated biotechnology or pharmaceutical company with progressive… more
- United Therapeutics (Trenton, NJ)
- …you're passionate about pharmacovigilance! You are a team player who loves quality , compliance , finding solutions and ensuring training standards are implemented ... This role in Global Patient Safety (GPS) will focus on enhancing and maintaining quality , training, and compliance (QTC) of GPS operations and practices. They… more
- Integra LifeSciences (Princeton, NJ)
- …material remediation experience. + Experience in implementing remediation programs, and working with compliance frameworks such as FDA , ISO 13485, and EU MDR is ... required + Strong analytical skills, exceptional writing and interpersonal relationship skills or a combination of relevant work experience and education is required. + Demonstrated organizational, management and communication skills is required. + Proven… more