Quality Assurance Manager , Specialty Pharmacy
Missisauga, Ontario
Greenshield Speciality Pharmacy – Pharmacy /
Permanent Full-Time /
On-site
The Quality Assurance Manager will play a pivotal role in maintaining and improving the quality standards across our specialty pharmacy, infusion clinics, nursing operations, and warehouse drug distribution. This individual will be responsible for developing and implementing a robust quality management system, tracking incidents, and driving continuous process improvement initiatives. The ideal candidate will ensure the proper implementation of Standard Operating Procedures (SOPs) and formalize training programs to educate staff on adherence to these SOPs.
Responsibilities
- Develop and Implement Quality Management System:
- Design, implement, and manage a comprehensive Quality Management System (QMS) that aligns with industry standards and regulatory requirements.
- Establish and maintain processes for document control, change management, and risk assessment.
- Oversee the tracking, analysis, and resolution of incidents related to quality, ensuring timely and effective corrective and preventive actions.
- Final Oversight on incident resolution and collaboration with managers
- Conduct thorough investigations into incidents and implement corrective measures to prevent recurrence.
- Lead and facilitate continuous improvement initiatives to enhance operational efficiency and quality outcomes.
- Collaborate with cross-functional teams to identify areas for improvement and implement best practices.
- Develop a quality council across businesses.
- Manage SOPs Governance, providing advisory and managerial support for overall business SOPS
- Ownership of SOPs for quality, including incident/capa
- Ensure the proper implementation and adherence to Standard Operating Procedures (SOPs) across all relevant departments.
- Regularly review and update SOPs to reflect current industry standards and regulatory requirements.
- Develop and deliver training programs to educate staff on the importance of SOPs and quality standards.
- Conduct periodic training assessments and address gaps in knowledge through targeted programs.
- Plan and conduct internal audits to assess compliance with SOPs and regulatory requirements.
- Generate regular reports on key quality metrics and performance indicators for management review.
- Provide data-driven insights to support decision-making and continuous improvement efforts.
- Collaborate with external auditors and regulatory bodies as needed.
What we are looking for
- Bachelor's degree in a relevant field (Quality Management, Pharmacy, Healthcare Administration, etc.).
- Proven experience in quality assurance within a healthcare or pharmaceutical setting.
- Familiarity with regulatory requirements, including but not limited to FDA, cGMP, and other relevant standards.
- Strong leadership and communication skills with the ability to collaborate effectively across departments.
- Experience in developing and implementing effective training programs.
- Knowledge of continuous improvement methodologies (e.g., Six Sigma) is a plus.
- Certification in quality management (e.g., ASQ Certified Manager of Quality/Organizational Excellence) is preferred.
NICE TO HAVE
