CPV & Data Sciences Leader

We are looking for a highly motivated CPV & Data Sciences Leader to join our team, who will be responsible for ensuring manufacturing processes remain consistently controlled, compliant, and continuously improving through the effective application of data science and digital tools. This role leads the design, implementation, and lifecycle management of Continued Process Verification (CPV) programs while transforming complex manufacturing and quality data into actionable insights that enhance product quality and operational performance.

The position plays a critical role in enabling advanced analytics, digital dashboards, and AI-driven monitoring to proactively identify risks and optimize processes. Acting as a bridge between Manufacturing, Quality, and Digital teams, the CPV & Data Sciences Leader drives scalable, data-driven decision-making across the entire process lifecycle.

This position is based in Whitby (Ontario), Hybrid.

Key Responsibilities:

• Lead the design, implementation, and lifecycle management of Continued Process Verification (CPV) programs.
• Define and monitor Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs) using statistical and risk-based methodologies.
• Establish and track key performance indicators (KPIs) to ensure process control, compliance, and continuous improvement.
• Analyze manufacturing and quality data to identify trends, variability, and risks impacting process performance.
• Apply statistical methods and data science techniques to support process monitoring and optimization.
• Translate complex datasets into clear, actionable insights for technical and non-technical stakeholders.
• Develop and maintain dashboards and reports using tools such as Discoverant and Power BI for real-time monitoring.
• Oversee data collection, integration, and trending from systems including MES, LIMS, and data historians.
• Act as the site Subject Matter Expert (SME) for Discoverant, including configuration, troubleshooting, and continuous improvement.
• Implement and support advanced analytics solutions, including AI and machine learning models.
• Drive adoption of digital manufacturing solutions and foster a culture of data-driven decision-making.
• Support digital transformation initiatives across manufacturing and quality operations.
• Support investigations related to deviations and Out-of-Specification (OOS) results through data-driven root cause analysis.
• Ensure all activities comply with Good Manufacturing Practices (GMP) and data integrity principles (ALCOA+).
• Provide data and documentation to support regulatory submissions, audits, and inspections.
• Collaborate with MSAT, Quality, Engineering, Automation, and IT teams to align CPV strategies.
• Mentor and provide technical guidance in CPV, data analytics, and digital tools.
• Lead initiatives that improve process performance and operational efficiency.

Requirements:

• Bachelor’s degree in Engineering, Data Science, Statistics, Pharmaceutical Sciences, or related field; training in data analytics tools (e.g., Python, R, JMP, SAS, Power BI, Discoverant).
• 3+ years of experience in pharmaceutical manufacturing, MSAT, process validation, or data analytics within a GMP environment.
• Proven experience leading or supporting Continued Process Verification (CPV) and process lifecycle validation.
• Strong expertise in statistical analysis (including multivariate methods) and applying data science to manufacturing or quality processes.
• Experience with manufacturing systems (MES, LIMS, data historians) and data-driven investigations (deviations, OOS).
• Solid understanding of GMP, data integrity (ALCOA+), and global regulatory expectations (FDA, EMA, ICH).
• Proficiency in data visualization and analytics tools (Python, R, JMP, SAS, Power BI, Discoverant).
• Demonstrated ability to translate complex data into actionable insights and influence cross-functional decisions.
• Strong leadership, collaboration, and stakeholder management skills in a regulated environment.
• Highly organized, detail-oriented, and able to manage multiple priorities effectively.
• Proficiency in Microsoft Office
• Fluent in English.