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Job Title: Manager, Quality Assurance

Job Location: Toronto, ON

Job Salary: $82,000 - $137,000

Job Reports to: Director, Quality Assurance

Department: Quality Assurance

Job Summary:

A leadership role with Quality Assurance responsible for the delivery of Alimentiv’s global quality assurance services, overseeing, collaborating and driving quality compliance in the delivery of Alimentiv services. This role is responsible for Document and Training Management as well as meeting the operational responsibilities and objectives and includes staff performance management, departmental process improvement and financial management.

Areas of Responsibility:

Operational Management

• • Implement, maintain, and improve the electronic Document Management and Training modules and processes within the eQMS to ensure compliance with current regulatory requirements governing clinical research.
  • Ensure operational efficiency and excellence by leading and/or assisting in the creation and documentation of new or revised department procedures.
  • Recommend appropriate departmental objectives that support the company strategy and objectives and create solutions to address business and operational challenges.
  • Partner with internal and external stakeholders.
  • Participate in department budget development and responsible for effective management of budgets.
  • Oversee the management of department projects and deliverables to ensure work is of high quality, meets timeline commitments and is well communicated to other stakeholders.

Team Management and Engagement

• • Identify and quantify resource requirements; Interview, hire, onboard and train new staff as appropriate.
  • Supervise, mentor, provide leadership and maintain positive team morale; facilitate conflict resolution.
  • Oversee development of direct reports by setting and tracking individual objectives and key results to support department and company strategies and objectives.
  • Evaluate training needs and conduct performance reviews for assigned staff.
  • Set priorities and oversee activities for assigned staff.

Quality Oversight and Support

• • Oversee the development, implementation and compliance tracking of QA plans (study, internal process and annual)
  • Oversee the identification of quality GCP risks and work with leaders to design mitigation strategies
  • Oversees and provides administration and troubleshooting for the document and training modules of the eQMS .
  • Maintains electronic master documents (Policies, Standard Operating Procedures, Work Instructions and Associated Documents) as required by applicable regulations.
  • Manages the document periodic review process.
  • Oversees document change control process.
  • Support Sponsors, corporate and clinical operational teams with global quality, regulations, ethics and privacy inquires.
  • Remain knowledgeable and current on industry environment and regulatory legislation.

Inspection/Audit/Assessment Activities

• • Oversee, as a member of the audit team, sponsor audits, and regulatory inspections including preparation, receiving the auditor/inspector, facilitating the logistics of the inspection (e.g. coordinating interview schedules and document provision), ensure findings are addressed appropriately, as applicable.
  • Oversee, as a member of the audit team, the facilitation of audits, including auditor identification (if required), and assisting with the conduct of the audit, as applicable.
  • Oversee the conduct vendor assessment activities, as applicable.

Qualifications:

• The successful candidate will possess either an undergraduate University Degree with 4-6 years of relative experience or, a College Diploma/Degree with 7-9 years of relative experience with continuous training and knowledge.
  
• Proficient in the use of electronic Quality Management Systems.
• Strong analytical, critical thinking and problem-solving skills required. Knowledge of ICH GCP, global regulations governing Clinical Research and global privacy regulations.

Working Conditions:

Home based, with the ability to come into the office when needed.

Accommodations for persons with disabilities are available on request in respect of all aspects of the recruitment and selection lifecycle. Requests can be directed to [email protected]