Event Deviation Change Management Expert

BioTalent Canada; Toronto; In loco; CAD 120.000 - 180.000; Tempo pieno

Descrizione del lavoro

Sanofi Canada is seeking a senior QA/Regulatory professional to lead investigations, CAPAs and change controls across the Canadian market and imported product portfolios. The role requires deep knowledge of GMPs, strong analytical skills, and the ability to influence cross-functional teams in a regulated environment.

You will partner with internal and external stakeholders, support audits, and drive continuous improvement to ensure compliant operations for Health Canada licenses.

Competenze

• Bachelor’s Degree in Science or equivalent required.
• 7-10 years of relevant experience in pharmaceutical QA/QC/Production or equivalent.
• Extensive knowledge of Canadian GMPs.
• Excellent analytical and problem-solving abilities.
• Excellent ability to influence without authority and overcome challenges.
• Experience with Canadian importation is highly preferred.
• Strong communication skills (written and verbal) in English; French is a plus.

Mansioni

• Own events, deviations, and CAPAs for Sanofi Canada documentation and investigations.
• Assess criticality of deviations and manage escalation to Local, Regional, and Global levels.
• Present and defend investigations, root causes, corrective actions, and product release decisions.
• Oversee change management for Canada market products and license activities.
• Ensure documentation and traceability with timely actions to minimize risk.

Conoscenze

Analytical skills

Problem-solving

Influence without authority

Communication skills

Interpersonal skills

Prioritization

Regulatory affairs liaison

Formazione

Bachelor’s Degree in Science or equivalent

Descrizione del lavoro

Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster.

POSITION SUMMARY:

Leadership role with indirect authority driving the investigation and CAPA commitments from Sanofi Canada internal and external partners to meet Health Canada requirements. High level of autonomy, authority and risk management as the owner of Event Deviations, CAPAs and Change Controls for Sanofi Canada for local activities as well as external activities for a substantial portfolio of imported products. This role leads these activities for all relevant Sanofi Business units performing GxP and health-regulated functions with a heavy focus on high risk GMP activities. The role is required to analyze organizational needs, develop and support operational plans and best practices to ensure a streamlined and fully compliant operation for the Sanofi Canada licenses.

Main Responsibilities:

Event/Deviation/CAPA

• Centralized process owner for Sanofi Canada aligned with Global requirements to document nonconformities, root cause and the implementation and tracking of appropriate corrective and preventative actions to drive product and process improvements, commensurate with the significance of the risk or deviation.
• Assesses criticality of deviations for Local, Regional and Global Quality escalation requirements and manages escalation process
• Presents and defends appropriateness of investigations, root cause determinations, corrective actions and product release decisions during audits and inspections

Change Management Operations

• Oversight and management of planned temporary or permanent changes to Canada market product, processes, license activities to align with Health Canada expectations for expectations for Importers
• Ensuring formal documentation, approval and traceability, effected in a timely manner, with a high degree of assurance that potential downstream impacts are appropriately assessed and proactively acted on to minimize risk and support product/process robustness

Other Responsibilities

• Drive the alignment with Global stakeholders, other teams and quality pillars as required
• Influence without authority and effectively advocate for Canadian market needs beyond Corporate Standard requirements
• Oversee the handling of QA documents based on established systems and processes. e.g. SOPs
• Assemble reports related to Change Controls, Events and CAPAs as required
• Serve in a backup capacity to Quality Lead and other Quality Specialists for their respective responsibilities as delegated
• Assist in the development and management of Training Program
• Metrics tracking for event deviation occurrence review and other related trending to reduce recurrences, improve performance and increase Quality standards
• Leads and participates in Continuous Improvement projects
• Works with internal and external stakeholders to provide Quality expertise related to Canadian market requirements
• Other duties as assigned

About You

Qualifications:

• Bachelor’s Degree in Science or equivalent.
• 7-10 years of relevant experience in pharmaceutical industry (Preferably in QA, QC, Production or equivalent).
• Extensive knowledge of Canadian GMPs.
• Excellent analytical and problem-solving abilities
• Excellent ability to influence without authority and overcome challenges.
• Experience with Canadian importation is highly preferred.
• Ability to maintain good interpersonal relationships Ability to set priorities
• Good communication skills (verbal and written)
• English: Excellent knowledge (reading, writing and oral)
• French: Written and spoken proficiency an asset

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.

Applications received after the official close date will be reviewed on an individual basis.

This position is for a new vacant role that is now open for applications.

AI Usage

"Artificial Intelligence" refers to any systems that use automated processes, including algorithms and machine learning, to analyze data and make predictions, inferences, decisions, or recommendations without direct human involvement. These systems may process personal information to identify patterns, improve services, or support decision-making. The Company may use Artificial Intelligence for purposes including, but not limited to, resume screening and hiring, scheduling interviews or meetings, conducting surveys, matching skills with potential job openings, interview scoring, ensuring compliance with regulations applicable to our industry, and activities related to performance evaluation. Information collected and processed by the Company’s Artificial Intelligence systems may include the personal information detailed above and calendar availability. It excludes the information collected and processed for monitoring purposes. You should contact Human Resources if you have a question or concern regarding your personal information. You can also contact Canada’s Privacy Officer via Sanofi’s data subject request portal,can also be used torequest access or correction of your personal information and file a complaint.

Sanofi is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. We welcome and encourage applications from all qualified applicants. Accommodations for persons with disabilities required during the recruitment process are available upon request.

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.

Join Sanofi and step into a new era of science – where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what’s never-been-done-before. You’ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people’s lives? Let’s Pursue Progress and Discover Extraordinary – together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law.

Final compensation will be determined based on demonstrated experience, skills, location, and other relevant factors. Employees may be eligible to participate in Company employee benefit programs.