GMP Professionals
On-siteMaple Grove, Massachusetts, United States
Job Summary
Ensure compliance with GMP regulations, standards, and guidelines across pharmaceutical manufacturing, packaging, and distribution processes. Review regulatory agency requirements and industry standards to align company policies, then develop and maintain quality systems including documentation control, change control, and CAPA. Conduct internal audits and inspections to assess compliance and identify improvement areas while collaborating with cross-functional teams to drive continuous improvement. Provide GMP training to personnel and support clients during regulatory inspections by addressing findings and implementing corrective actions. Stay current on regulatory updates and industry best practices.
Required Qualifications
- Bachelor's degree in pharmacy, chemistry, biology, engineering, or related field
- Minimum of 5 years of experience in GMP compliance within the pharmaceutical, biotechnology, or medical device industry
- Deep understanding of GMP regulations and guidelines applicable to pharmaceutical manufacturing, packaging, and distribution activities
- Experience with GMP quality systems, including document management, change control, deviations, and CAPA
- Strong analytical and problem-solving skills, with the ability to interpret and apply complex regulatory requirements
- Excellent communication and interpersonal skills, with the ability to collaborate effectively with internal and external stakeholders
Desired Qualifications
- Advanced degree
- Auditing experience and knowledge of audit principles and practices
- Regulatory affairs certification (RAC)
- Relevant professional certification (e.g., ASQ Certified Quality Auditor)
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