Project Leader, MST Process Validation

Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.

Responsible for the development, tracking and execution of projects within the Portfolio. The Project Leader is accountable to ensure all tasks and requirements related to projects are delivered through leading of various cross-functional teams and through timely escalation as required.

Collaborate with Stakeholders and all functional areas across the business to achieve successful project execution. Provide status updates to the Supervisor, as required and notification of any potential project delays/risks as they arise. Works directly with other department staff both internally and externally to capture and report on their projects.

In addition, the Project Leader MST-Process Validation is responsible for managing and ensuring the compliance of projects related to Process Validation and for the review of proposed validation documentation and strategies which ensure the validation program remains compliant with the Health Canada, FDA, EU and other regulatory guidelines. Responsible for providing guidance and acting as a resource with knowledge pertaining to the regulatory requirements of validation for various departments such as Quality, Production, Regulatory Affairs and other subsidiary groups within MST Validation.

• Works in a safe manner collaborating as a team member to achieve all outcomes.
• Demonstrate Behaviours that exhibit our organizational Values:
  Individual Accountability, Rigour & Discipline, Continuous Improvement
• Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
• In the absence of Supervisor, oversees daily Process Validation (PV) activities, supporting issue resolution, and ensuring timely execution of validation deliverables. Prioritizes projects and coordinates with stakeholders to meet compliance timelines and resolve scheduling conflicts.
• Collects, analyzes, and interprets manufacturing process and quality data; performs statistical evaluations to assess process performance, identify trends and variability, and support data-driven decision-making. Generates CPV reports that verify processes remain stable, capable, and in a validated state.
• Reviews and approves validation protocols, reports, change controls, technical documentation, and validation strategies to ensure compliance with regulatory requirements, the Process Validation Master Plan (PVMP), and site procedures.
• Provides validation expertise and guidance to cross-functional teams, supports investigations, deviations, corrective actions, change controls, product launches, site transfers, and process improvement initiatives.
• Leads validation-related projects, monitors progress, communicates status to management, and serves as the primary liaison for process capability and validation activities.
• Supports regulatory inspections and audits, acts as an authorized designate for protocol and report approvals, and assists with the training and development of employees and internal stakeholders.
• Performs other relevant duties as assigned.

Education

• Degree, Diploma or Certification in Chemistry, Pharmaceutical Technology or related science
• Demonstrated high level of knowledge, skill, or expertise in all validation concepts, with experience using statistical tools (e.g. JMP) for evaluation of process capability and control.
• Excellent oral and written communication skills.
• Demonstrated ability to work effectively as a team member with employees at all levels of the organization.
• Strong interpersonal skills.
• Excellent problem solving and troubleshooting abilities.
• Ability to analyze and recommend process improvement.
• Proven organizational, time management, and project management skills.
• Intermediate to advanced computer skills in MS Excel, Word, Access, Microsoft Project, required.

Experience

• Minimum 5 years of pharmaceutical manufacturing experience.
• Minimum of 3 years experience in a Validation role.
• Knowledge of and experience with automation, data analytics, and visualization tools for CPV, process monitoring, and data management is preferred. Experience developing automated dashboards, reports, and workflows that drive data-driven decision-making, improve process oversight, maintain data integrity, and support quality and regulatory compliance is highly desirable.

At Apotex, we are committed to fostering a welcoming and accessible work…