Siltech Corporation, a Canadian owned global provider of organo-functional silicone specialties, is looking to hire immediately a GMP (Good Manufacturing Practices) Manager. This position will be located at our new Fort Erie Plant, but will require travel to our Toronto and Mississauga Plants as needed.
This opportunity offers a full Benefits and Pension package.
Reporting to the Operations Manager, this role ensures the manufacturing plants operate in full compliance with GMP within certification scope, internal quality standards, and applicable regulatory requirements. This role oversees quality systems related to batch production, continuous manufacturing, raw materials, intermediates, final product release, and chemical handling operations.
Main Duties
- GMP Compliance
- Develop, implement, and maintain GMP policies, SOPs, and quality systems aligned with regulatory standards and current ISO 9001 quality management system
- Ensure plant-wide adherence to GMP requirements for chemical handling, batch processing, packaging, and storage
- Communicate improvement plans to achieve objectives and performance against those plans
- Leverage GMP work processes to the non-GMP aspects of the plants where it adds value
- Oversee document control including batch records, deviations, change controls, and CAPAs
- Conduct internal GMP audits and coordinate external GMP audits (regulatory agencies, customers, certification bodies).
- Production Oversight
- Partner with Plant Managers to ensure manufacturing processes operate in compliance with GMP standards
- Review and approve process changes, equipment modifications, and new chemical introductions
- Support troubleshooting of quality and compliance issues during production runs.
- Training & Competency Management
- Develop and deliver GMP training programs for all levels of plant staff
- Ensure personnel qualifications and training records meet regulatory expectations
- Instill a GMP mindset in the company culture.
- Documentation & Reporting
- Maintain accurate and complete quality records, including incident investigations and deviation reports
- Prepare compliance reports, audit summaries, and improvement plans for leadership
- Drive timely closure of CAPAs and preventive actions.
- Risk Management & Continuous Improvement
- Identify compliance risks and gaps through assessments, audits, and trend analysis
- Lead initiatives to improve process controls, documentation accuracy, and product quality
- Lead root cause analyses for quality failures or nonconformances.
- Regulatory & Customer Interface
- Serve as the primary point of contact for GMP regulatory inspections and customer audits
- Interpret new or updated regulations and translate them into plant policies and training.
Knowledge required
- 5+ years in a GMP-regulated chemical, API, specialty chemicals, food, or industrial manufacturing environment
- Bachelor’s degree in Chemistry, Chemical Engineering, Industrial Engineering, Quality, or related discipline (required)
- Advanced degree or quality certification (ASQ CQE, CQA, or similar) preferred
- Strong familiarity with:
- Chemical batch processing
- GMP and quality system requirements
- OHSA/Environmental/Labour standards
- Hazardous material handling (GHS/CLP)
- Experience with electronic QMS systems.
Skills & Competencies
- Strong understanding of chemical manufacturing workflows and GMP requirements
- Comprehensive knowledge of root cause analysis and risk assessment tools
- Excellent organization and documentation skills
- Strong communication skills with ability to work across diverse technical teams
- Attention to detail, analytical mindset, and commitment to safe chemical operations
- Knowledge of process sterilization techniques would be an asset
- Six Sigma certification and Lean Manufacturing certification would be an asset.
Please apply at HR@Siltech.com with the job title as subject reference.
Please refer to Siltech Careers page for more opportunities.