QMS Senior Specialist

• Author and review relevant procedures and SOPs across functional teams.
• Prioritize safety as a fundamental goal throughout the organization.
• Configure and maintain QMS systems (e.g., TrackWise, eDMS, SFLMS) to support GxP compliance, authoring SOPs and Work Instructions.
• Coordinate the site change control system, ensuring all changes with potential product quality impacts are thoroughly evaluated and controlled.
• Manage the site CAPA system, crafting efficient actions, ensuring timely completion, and coordinating effectiveness checks.
• Conduct site-level corporate standards gap assessments to ensure compliance with regulatory requirements.
• Manage document and record management systems, overseeing effective execution and compliance with site requirements.
• Lead the development and execution of GMP training systems, creating training modules and annual plans.
• Develop annual product quality review plans, perform reviews, and implement CAPAs.
• Complete the site self-inspection program by developing annual plans, conducting inspections, and performing trend analysis.
• Ensure site readiness for client and regulatory audits, participating in hosting and managing responses to audit findings.
• Support the site management review process, collecting and analyzing quality data, and driving continuous improvement.
• Coordinate the site supplier management program, managing Quality Agreements, supplier change control, and participating in supplier evaluations.
• Lead and support Practical Process Improvement (PPI) activities related to QMS projects.
• Maintain the site data integrity system, ensuring efficient processes are in place.
• Perform and complete other related duties as assigned by the company.

Education

• Bachelor's Degree or equivalent experience in Life Sciences, Chemical/Biochemical Engineering, or a related scientific area.

Experience

• 5-8 years of relevant quality experience in the pharmaceutical industry preferred.
• Experience with Quality Management Systems, specifically TrackWise.
• Experience in biologics and aseptic training is an asset.
• Strict experience in site data integrity management is essential.

Proficiencies

• Practical knowledge of cGMP and regulatory compliance.
• Strong critical thinking and effective communication.
• Proven coordination and teamwork skills.
• Ability to lead executions and achieve results.
• Excellent problem-solving skills with a focus on continuous improvement and quality risk management.