Bulk Antigens Quality Continuous Improvement (CI) Specialist-Vaccines

Bulk Antigens Quality Continuous Improvement (CI) Specialist-Vaccines

Position Title: Bulk Antigens Quality Continuous Improvement (CI) Specialist-Vaccines

Department: Site Quality Operations/ OQSA

Location: Toronto, Ontario

About the Job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

Sanofi Manufacturing and Supply is starting an accelerated journey for all our sites to improve performance using the SMS 2.0 Framework. The role is to drive Industrial excellence to achieve the Process Centric Unit’s (PCU’s) Strategy and Ambition. The CI Specialist brings a high level of expertise and leadership in lean methodology, industrial performance, digital solutions, transformation and change management.

The main impact expected for the CI Specialist is to support PCUs to reach the targeted level of performance related to the area Strategy and glidepath.

The main impact expected from a compliance perspective is to maintain, improve and ensure compliance of operational quality processes owned by OQSA to all Global Standards and regulatory commitments. Additionally, the incumbent will also support deviation investigations, project implementations as required, and will work within the Quality System.

This role will support Quality PCU teams for Bulk Antigen Manufacturing (for example: B89, B90, B100).

Main Responsibilities:

Strategy

• Continuously analyses the performance of the PCU and supports the performance & continuous improvement actions.
• Contributes to the definition of the PCU's trajectory with the PCU Manager and the CI (Continuous Improvement) Specialist Level 2 in line with the site's critical needs.
• Build SMS 2.0 standards in PCU to drive performance.
• Improve Data Governance at PCU level.

Performance

• With the Area Management, build the PCU's performance plan (duration less than 1 year, action carried out by the PCU and specific to the PCU).
• Ensures CI initiatives are delivered on-time and within established budgets, while delivering the committed value to the PCU performance.
• Ensures PCU achieves the CI cost savings target through implementation of CI projects within the targeted time.
• Help implement the CI culture in the shop floor.
• Leads the PCU's continuous improvement meetings.
• Provide leadership and coaching to ensure that PCU Performance delivers well-defined and quantified outcomes.
• Through a strong Gemba presence, conducts regular Gemba's to coach the teams on waste identification and perform confirmation processes.
• Contributes to the network with the community of continuous improvement specialists to align practices and advance SMS standards.

Compliance Related Tasks

• Ensure compliance with requirements of cGMP and the site quality program.
• Fully completes departmental objectives and complies with budget targets.
• Ensure compliance to cGMP at all times.
• May work within the Quality System to deliver objectives of the PCU.

HSE REQUIREMENT/STATEMENT

• Works within the policies, procedures and regulations as required by the Company and under the Occupational Health and Safety Act.

About You

Requirements:

Education/Certifications

• Degree in Life Sciences or Engineering.

Experience

• 5+ years of experience in the pharmaceutical industry.
• 5+ years in operational roles including Quality experience.
• Experience in Team Leadership would be an advantage.
• Experience in Project management would be an advantage.

Competencies

• Knowledge in Lean Manufacturing and experience in partaking in transformation programs (such as Fit4 or equipment excellence) would be advantageous.
• Green / Black Belt Certification would be advantageous.
• Good functional knowledge on PCU operational/functional processes.
• Ability to analyse and make data driven proposals.
• Ability to coordinate multiple CI programs.
• Capability in data analysis and diagnostics.
• SMS certification intermediate level within 6 months.
• Knowledge on GPS3 methodologies.
• Fluent English spoken and written.
• Good knowledge of plant operations.
• Strong communication skills.
• Ability to lead projects.
• Ability to influence at all levels.
• High level of autonomy.
• Problem Solving skills.
• Strong Computer Literacy.

Personal Characteristics

• Independent, open-minded thinker and a good active listener.
• Energetic in the pursuit of improved processes and ultimately of improved performance.
• Analytical and thorough in the completion of their work.

Play to Win Behaviours

Stretch

• Takes calculated risks, seeks diverse views to challenge thinking, ruthlessly prioritizes to deliver the most value and constantly looks for ways to apply learnings and drive improvement.

Take Action

• Prioritizes outcomes over activity, focuses on what is important now, and follow-up on what can be improved, focuses on solutions rather than what/who caused the issue.

Act for Patients & Customers

• Always looks at what is best for our patients and customers in any solution.

Think Sanofi First

• Shares information openly and proactively with all colleagues, seeks what is best for Sanofi rather than best for him/herself or his/her team/function/GBU and dares to challenge his/her management and team if needed to help colleagues across the organization to be successful.

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.
• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs.