CPV & Data Sciences Leader

Job description

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.

Expected Compensation Range:
50-100k per year. The final compensation offered will be determined based on the candidate’s level of experience, skills, and qualifications, in compliance with applicable pay transparency requirements.

Canadian Experience Requirement:
No Canadian work experience is required for this position. Candidates are encouraged to apply regardless of previous Canadian experience.

Artificial Intelligence (AI) Disclosure:
No Artificial Intelligence (AI) tools are used in the screening, assessment, or selection of candidates for this position. All stages of the recruitment process are conducted by human recruiters and hiring managers.

Statement Regarding Job Vacancy:
This position is a Job creation, created to support ongoing project needs.

Recruitment Process & Feedback Timeline:
Candidates will receive feedback on their application within a maximum of 45 days from the date of application or from their most recent interview stage.

Why choose us

• An international community bringing together more than 110 different nationalities
• An environment where trust is central: 70% of our leaders started their careers at the entry level
• A strong training system with our internal Academy and more than 250 modules available
• A dynamic work environment that frequently comes together for internal events (afterworks, team buildings, etc.)

Amaris Consulting promotes equal opportunities. We are committed to bringing together people from diverse backgrounds and creating an inclusive work environment. In this regard, we welcome applications from all qualified individuals, regardless of sex, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.

Who are we?

Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1,000 clients across the globe, we have been rolling out solutions in major projects for over a decade – this is made possible by an international team of 7,600 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.

At Amaris, we strive to provide our candidates with the best possible recruitment experience. We like to get to know our candidates, challenge them, and be able to give them proper feedback as quickly as possible. Here's what our recruitment process looks like:

Brief Call: Our process typically begins with a brief virtual/phone conversation to get to know you! The objective? Learn about you, understand your motivations, and make sure we have the right job for you!

Interviews (the average number of interviews is 3 - the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities!

Case study: Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario, etc.

As you know, every person is different and so is every role in a company. That is why we have to adapt accordingly, and the process may differ slightly at times. However, please know that we always put ourselves in the candidate's shoes to ensure they have the best possible experience.
We look forward to meeting you!