Title: Manager Lead Investigator - Vaccines - Contract
Reference No: R2590483
Location: Toronto, Ontario
Contract end date: 2022-05-31
Sanofi Pasteur: The world’s leading vaccine company
Sanofi Pasteur, the vaccines division of Sanofi, is the largest company in the world devoted entirely to human vaccines. Our driving goal is to protect people from infectious diseases by creating safe and effective vaccines. Our company distributes more than 1 billion doses of vaccine each year, making it possible to vaccinate more than 500 million people across the globe. Sanofi Pasteur offers the broadest range of vaccines in the world, providing protection against 20 bacterial and viral diseases.
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.
Summary of purpose/major responsibilities
This position will support BRD staff through leading the application of specialist expertise and influence of strategies in alignment with BRD’s strategies, goals and DKMs. Administers and maintains relevant supporting systems.
This role requires collaboration with BRD personnel other personnel across the site as well as alignment with key stakeholders across Sanofi Pasteur globally.
Continuous improvement and demonstration of Subject Matter Expertise in their area of expertise is also expected from this position.
Specialist: Lead application of expertise and influence strategies related to effective deviation management and continuous improvement to help BRD advance its Mission.
Collaborate with R&D SQO, SME’s, platform management and frontline staff, as required.
Participate, contribute or lead QN investigations where BRD is impacted or impacting another area ( ARD, IO).
Develop investigation strategy and required collaborators / expertise and manage contributions from other departments (ARD, IO).
Facilitate identification of root cause
Facilitate deviation related CAPA definition and responsible for general oversight and monitoring of QN related CAPAs to assess effectiveness.
Responsible for on-time completion of quality deviation reports and management of deviation review process.
Electronically sign off deviations.
Representative for investigations during GMP inspections, as required.
Sphere of Influence/Impact: Collaborate/coordinate work across BRD and site. Liaise across Sanofi Pasteur globally.
Define and implement process to triage BRD deviations based upon risk and impact.
Identify recurrent issues or themes and work across BRD, site and Sanofi Pasteur globally (as relevant) to identify and develop process improvement plans to remediate quality risks and drive continuous improvement.
Review non-CMP platform deviation reports to ensure best practices applied and transversal understanding of BRD deviations.
Promote site practices or current best practices where appropriate (e.g. use of appropriate deviation report templates).
Provide weekly quality metric reports to enable BRD teams to proactively manage quality performance.
Responsibilities: Lead the execution and completion of DKMs for projects and non-project work.
Context of the job/major challenges
Effective quality notification/deviation management is a key mechanism through which continuous improvement and risk reduction can be achieved.
The purpose of this role is to effectively lead the management of Quality Notifications and related CAPAs in collaboration with clinical manufacturing and support members.
This will include employing Root Cause Analysis Methodologies, facilitating effective CAPA development and implementation, analysis of recurring deviations, and assessment of system performance relative to quality metrics to identify and collaboratively implement improvements in quality notification management.
The primary focus of this role will be to support the clinical manufacturing platform however, the skill sets applied to lead quality notification investigations may also be transversally applied to support BRD in collaborative problems solving and ideation.
In addition, the purpose of this role is also to serve as a change agent to ensure continuous improvement principles and quality mindset are applied to effectively improve performance of clinical manufacturing platform through quality notification management.
Decisions require interpreting and acting on established policies and procedures that may require occasional interpretation within a defined unit.
Responsible for leading the application of expertise and influencing the strategy in their field within BRD NA and across the site.
Inadequate application of their field of expertise can lead to delays in achievement of DKMs and subsequently advancement of the New Vaccine Project portfolio.
Adheres to all quality and safety practices in compliance to all relevant regulatory, Sanofi/ Sanofi Pasteur local and global procedures.
Recommended Education Level:
Recommended Relevant Industry Experience:
Solid knowledge and demonstrated aptitude of current Quality Notification processes, systems and requirements.
A broad understanding of BRD production process, ARD processes/systems and the Quality Operations processes/systems.
Strong knowledge and understanding of GMPs are critical as the position requires interaction with GMP areas such as BRD production and stability program, QO and ARD analytical testing labs as well as the R&D SQO team.
Proficient in following software: Outlook, PowerPoint, Word, Excel and Visio. Specialized software: SAP, Qlikview, QeDoc, ReD and R&D Trackwise for CCRs and CAPA. Supplementary: ProCal, Rapid Pharma, Master.
Effective communication skills are required; this individual is required to communicate clearly & concisely at all levels.
Analytical problem solving skills are required, this individual will be required to use root cause analysis techniques to determine the cause of problems.
Creative problem solving skills are required, this individual will be required to work with people at all levels during troubleshooting sessions.
Strong facilitation and conflict resolution skills are required to help manage team dynamics and influence people that this individual has no authority over.
Effective time management skills to recognize and attend to appropriate priorities.
Good presentation skills and ability to publish metrics/reports.
Possess initiative and ability to lead or drive processes or projects to completion.
Flexible, creative and resourceful to accommodate various work schedules of investigation stakeholders while keeping on track for closure dates.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.