Digital Transformation Lead - Pharma

Job description

Amaris Consulting is looking for a Digital Transformation Lead to assess the digital maturity of a Canadian pharmaceutical contract manufacturer and define its multi-year digital roadmap.

The site is converting to aseptic liquid filling and expanding its filling capacity. Before introducing advanced technologies, it needs strong foundations for data capture, traceability, integration and governance.

You’ll assess how data is collected, reviewed and used across the shop floor, then define the path from the current environment to a connected and efficient operation. The role combines technology, stakeholder management and change leadership.

You’ll be the client’s single point of contact for this scope and will meet the client during the selection process.

Your responsibilities

Digital maturity assessment

• Map the current environment across the shop floor, IT and operational technology, including equipment connectivity, control systems, MES, SAP, LIMS, QMS, data historians, paper records and network infrastructure.
• Assess the site’s digital maturity against a recognised reference model, such as ISA-95 or an industry digital plant maturity model.
• Trace how data is captured, recorded, reviewed and trended.
• Identify gaps in data traceability, data integrity and system integration.
• Interview and run workshops with operations, quality, engineering, maintenance, IT and site leadership.
• Document current pain points, business needs and transformation priorities.

Digital roadmap

• Define the target state for shop floor data collection, data structures, equipment connectivity and system integration.
• Describe how equipment, MES and SAP should exchange data in both directions.
• Build a phased, multi-year roadmap that starts with core foundations before advanced analytics and AI.
• Set out dependencies, sequencing, quick wins and key decision points.
• Estimate the effort, cost range, risks and expected benefits of each initiative.
• Support business cases for site leadership.
• Make sure the new aseptic filling capacity is designed with the target architecture in mind.
• Define the CSV and data integrity implications of each initiative, in line with GAMP 5 and FDA 21 CFR Part 11.
• Recommend technologies and vendors based on the site’s needs.
• Support vendor assessments and selection when required.

Stakeholder management and change

• Act as the client’s main contact for this scope.
• Manage expectations and build sponsorship among site leadership and key business functions.
• Explain the reasons for change in practical terms.
• Involve end users in the design and prepare teams for new ways of working.
• Define training and adoption activities for the roadmap.
• Present the assessment findings, target state and roadmap to site leadership and steering committees.

Your profile

Required experience

• Degree in engineering, computer science, information systems or a related field.
• 10 or more years of experience in pharmaceutical or biotech manufacturing.
• At least 5 years of experience in manufacturing IT, operational technology or digital transformation.
• Experience leading a site-level digital maturity assessment or digital roadmap in a GMP environment.
• Hands-on knowledge of MES platforms such as Syncade, PAS-X, POMSnet or Opcenter, including their integration with ERP systems, ideally SAP.
• Strong understanding of shop floor data architecture, including control systems, data historians, industrial connectivity and the ISA-95 model.
• Working knowledge of CSV, data integrity, ALCOA+, GAMP 5 and FDA 21 CFR Part 11.
• Experience running workshops and leading change with operations, quality and IT teams.
• Confidence presenting to site leadership and steering committees.
• Eligibility to work in Canada.

Nice to have

• Experience with a CMO or CDMO, or with a site at an early stage of digital maturity.
• Background in aseptic or sterile manufacturing and EU GMP Annex 1.
• Experience with electronic batch records, review by exception or paperless operations.
• Knowledge of LIMS, QMS and maintenance systems, including their connection to shop floor systems.
• Familiarity with industrial data platforms, OPC UA, unified namespace approaches and manufacturing analytics.
• Change management certification, such as Prosci.
• Project management certification, such as PMP.

Expected Compensation Range:
90K-120K 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, part of Mantu 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!