Senior Director of Quality Assurance

The Senior Director of Quality Assurance will oversee the quality system, ensuring both quality assurance and control across all stages of production and manufacturing for the organization. This role includes leading the QA team, adhering to established policies, and driving continuous improvement in quality standards. Key Responsibilities: Lead and oversee the QA department, ensuring smooth and efficient operations. Ensure daily production and operational quality, including equipment and environment monitoring and managing deviations. Communicate quality concerns and risks promptly to senior management and the compliance team. Ensure all processes, from supplier qualification to distribution, comply with relevant standards and internal SOPs. Maintain the integrity and accuracy of batch records and other quality-related documentation. Manage product documentation in accordance with SOP requirements. Ensure staff training is properly conducted, documented, and validated for effectiveness. Oversee supplier qualification and verify receipt of necessary documentation from suppliers and vendors. Maintain accurate inventory, ensuring traceability logs are current and correct. Assist in preparing and reviewing validation protocols and reports, including transport, temperature mapping, and stability studies. Supervise the environmental monitoring program to ensure proper execution. Ensure products are handled, stored, sampled, and destroyed in compliance with regulations. Manage sample tracking, label reviews, and assessments. Monitor labeling and packaging material use and storage. Review and approve complex documents, including manufacturing validation protocols, batch records, and investigations. Support and follow up on out-of-specification product investigations. Qualifications: Bachelor’s degree in Science or related field. 10 years of relevant experience in GMP and cGMP environments, specifically within the pharmaceutical and natural health product industries. Extensive knowledge of industry standards (e.g., HC GMP, ICH, CGMP, GLP). Strong leadership and communication skills. Proven ability to manage teams and collaborate effectively. Familiarity with statistical methods and tools for quality improvements. Ability to thrive in a fast-paced, dynamic environment. Positive, solution-oriented mindset with a proactive approach. Strong understanding of regulatory and application requirements.

Location: Toronto, CA

Posted Date: 10/5/2024