Senior Regulatory & GMP Compliance SME
About the role
Job Description We are seeking a Senior Regulatory & GMP Subject Matter Expert with extensive experience in Quality Control laboratories, GMP compliance, regulatory expectations, and laboratory remediation initiatives. The ideal candidate will lead compliance assessments, identify GMP gaps, develop remediation strategies, strengthen quality systems, and support inspection readiness while ensuring alignment with global regulatory requirements. Key Skills Develop and implement documented surveillance and compliance monitoring processes. Conduct GMP gap assessments of QC laboratory systems, procedures, processes, documentation, and practices. Evaluate laboratory operations for compliance with GMP regulations, Data Integrity requirements, laboratory best practices, and Health Canada, FDA, and international regulatory standards. Develop phased corrective action and remediation plans. Prioritize compliance risks and remediation activities. Support implementation and effectiveness verification of corrective actions. Review SOPs, investigations, CAPAs, deviations, OOS/OOT processes, and laboratory controls. Support inspection readiness and audit preparation activities. Required Qualifications 10+ years of GMP Quality or QC Laboratory experience. Strong knowledge of GMP regulations. Strong understanding of QC laboratory operations. Expertise in Data Integrity. Experience with regulatory inspections. Strong knowledge of Quality Systems. Demonstrated experience performing GMP gap assessments and remediation activities. Experience supporting regulatory agency inspections. Additional Skills Compliance assessment expertise. Laboratory remediation planning. Compliance risk prioritization. Corrective action implementation and effectiveness verification. Inspection readiness and audit support.
Not the right fit? Search for Regulatory & GMP Compliance SME jobs in Ottawa, Ontario, Canada
About RevereIT LLC
RevereIT LLC offers a wide range of staffing and consulting services to its clients to conquer the technological edge. We provide our clients with the best available strategic advice and manpower support. Our consultants specialize in a wide range of technologies, processes, products & operating systems and have experience in proven methodologies to optimize legacy systems and to integrate them with leading-edge technologies.
RevereIT LLC offers smart solutions for its clients for all their staffing requirements. We provide solutions to our clients at a very competitive rate. Our team is wise, creative and enthusiastic, and challenges the latest technology.
RevereIT LLC is committed to providing the best resources and solutions to our clients. We maintain win-win relationships with our clients. We firmly believe that our success depends on your success.
Regulatory Compliance- Are you ready for the stringent standards and Strict timelines? RevereIT LLC can help you meet your deadline! The pharmaceutical industry is faced with unprecedented business challenges: rising costs, reduced government reimbursement, growing consumerism, and increased government regulation, such as 21 CFR Part 11, QA/QC, Computer System Validation, HIPPA.
Our Quality Assurance and Regulatory Compliance consulting group provides customers with unparalleled industry experience. By making wise IT investments and fundamental changes to business models, Organizations can reduce their costs, streamline administrative processes, empower consumers, improve quality of care and increase the speed of new discoveries to market.
Partnering with many of the major Pharmaceutical, Biotech companies and Specialist consultancies to help them to exceed their regulatory obligations, RevereIT LLC is rapidly becoming the market leader in the recruitment of professionals in the Validation & Regulatory Compliance market.
Similar Jobs
Senior Regulatory & GMP Compliance SME
About the role
Job Description We are seeking a Senior Regulatory & GMP Subject Matter Expert with extensive experience in Quality Control laboratories, GMP compliance, regulatory expectations, and laboratory remediation initiatives. The ideal candidate will lead compliance assessments, identify GMP gaps, develop remediation strategies, strengthen quality systems, and support inspection readiness while ensuring alignment with global regulatory requirements. Key Skills Develop and implement documented surveillance and compliance monitoring processes. Conduct GMP gap assessments of QC laboratory systems, procedures, processes, documentation, and practices. Evaluate laboratory operations for compliance with GMP regulations, Data Integrity requirements, laboratory best practices, and Health Canada, FDA, and international regulatory standards. Develop phased corrective action and remediation plans. Prioritize compliance risks and remediation activities. Support implementation and effectiveness verification of corrective actions. Review SOPs, investigations, CAPAs, deviations, OOS/OOT processes, and laboratory controls. Support inspection readiness and audit preparation activities. Required Qualifications 10+ years of GMP Quality or QC Laboratory experience. Strong knowledge of GMP regulations. Strong understanding of QC laboratory operations. Expertise in Data Integrity. Experience with regulatory inspections. Strong knowledge of Quality Systems. Demonstrated experience performing GMP gap assessments and remediation activities. Experience supporting regulatory agency inspections. Additional Skills Compliance assessment expertise. Laboratory remediation planning. Compliance risk prioritization. Corrective action implementation and effectiveness verification. Inspection readiness and audit support.
Not the right fit? Search for Regulatory & GMP Compliance SME jobs in Ottawa, Ontario, Canada
About RevereIT LLC
RevereIT LLC offers a wide range of staffing and consulting services to its clients to conquer the technological edge. We provide our clients with the best available strategic advice and manpower support. Our consultants specialize in a wide range of technologies, processes, products & operating systems and have experience in proven methodologies to optimize legacy systems and to integrate them with leading-edge technologies.
RevereIT LLC offers smart solutions for its clients for all their staffing requirements. We provide solutions to our clients at a very competitive rate. Our team is wise, creative and enthusiastic, and challenges the latest technology.
RevereIT LLC is committed to providing the best resources and solutions to our clients. We maintain win-win relationships with our clients. We firmly believe that our success depends on your success.
Regulatory Compliance- Are you ready for the stringent standards and Strict timelines? RevereIT LLC can help you meet your deadline! The pharmaceutical industry is faced with unprecedented business challenges: rising costs, reduced government reimbursement, growing consumerism, and increased government regulation, such as 21 CFR Part 11, QA/QC, Computer System Validation, HIPPA.
Our Quality Assurance and Regulatory Compliance consulting group provides customers with unparalleled industry experience. By making wise IT investments and fundamental changes to business models, Organizations can reduce their costs, streamline administrative processes, empower consumers, improve quality of care and increase the speed of new discoveries to market.
Partnering with many of the major Pharmaceutical, Biotech companies and Specialist consultancies to help them to exceed their regulatory obligations, RevereIT LLC is rapidly becoming the market leader in the recruitment of professionals in the Validation & Regulatory Compliance market.