Manager, Quality Assurance

2 weeks ago

Montréal, Canada Alimentiv Full time

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 meeting the operational responsibilities and objectives and includes staff performance management, departmental process improvement and financial management.

Reports to: Director, Quality Assurance.

**Role & Responsibilities**:

- ** Operational Management (35-40%)**:

- 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 & Engagement (15-20%)**:

- 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 & Support (30-35%)**:

- Oversee the development, implementation and compliance tracking of QA plans (study, internal process and annual)
- Oversee department support of study operational teams with resolution of escalated issues
- Oversee the identification of quality GCP risks and work with leaders to design mitigation strategies
- Oversee the investigations, audits or QA related corporate initiatives.
- 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 Trials, inspections including pre-inspection preparation, receiving the auditor/inspector, facilitating the logistics of the inspection (e.g. coordinating interview schedules and document provision), ensure findings are addressed appropriately
- Oversee the facilitation of audits, including auditor identification (if required), and assisting with the conduct of the audit
- Oversee the conduct vendor assessment activities

**Qualifications**:

- Minimum of an undergraduate degree
- English language skills are required to collaborate with stakeholders globally
- 7-9 years of progressive experience in Quality Assurance in Clinical Research including Audit Management, CAPA/Issues Management, and Document Management (preferred)
- Experience and expertise in Quality System Management (e.g., ISO 9001)
- Advanced/expert knowledge of Good Clinical Practices (GCP)
- Experience leading people and teams (preferred)
- Experience in Validation (preferred)

**Criteria for Success**:

- Quality Management System (QMS) Development
- Ensuring on-time CAPA/Issues Management
- People leadership and development
- Developing and analyzing departmental metrics

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