Manager, Stability - Toronto, Canada - Sanofi US

Sanofi US

Verified Company

Toronto, Canada

2 weeks ago

Posted by:

Sophia Lee

beBee Recruiter

Description

Reference No. R2671496

Position Title:
Manager, Stability

Department:
Stability

Location:
Sanofi Pasteur Limited, Toronto

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.

Position Summary:

The Stability Manager will prepare and execute compliant stability programs for Routine, Initial and Special Studies
(including change control, clinical, non-clinical and intermediate studies) categories.

The incumbent will facilitate all aspects of stability study lifecycles to ensure compliance and timely execution and closure. A contribution to quality-based initiatives, at both a documentation and process level, is expected.

The Stability Manager will prepare and execute stability data for Department colleagues, Industrial Operations and other departments in order to ensure the submission of new product licenses and control the necessary changes to licensed/marketed products as required.

Key Responsibilities:

Routine and Special Studies (60%)

Work with crossfunctional teams to prepare for and execute routine, initial and special studies as required; prepare appropriate documentation (e.g. forecasts, protocols, reports).
Manage stability lifecycles to ensure compliance and timely execution and completion (i.e. preparation of interiM/Final documentation, distribution of samples, organization /compilation /verification of data and determination of study conclusions); ensure a smooth transition through each phase and provide resolution to scheduling conflicts (i.e test schedules), as well as compliance issues.

Regulatory Submission (20%)

Biological Product Deviation Reports (5%)

Support investigations related to deviation reports (e.g. biological product deviation reports to CBER are prepared and sent for filing in a timely manner, and follow ups are performed.)

Compliance and Performance (15%)

Ensure training is up to date to perform the designated cGMP activities and requirements for Health and Safety.
Execute changes of stability protocols to ensure change controls are completed in time and support the update of site procedures to new and revised Global Quality Directives (GQDs).
Provide support to regulatory inspections, audits, and ensure responses and CAPA actions are completed by the designated target date.
Support the investigations and closure of quality incidents/deviations, as well as the completion of Corrective and Preventative Actions (CAPA) and subsequent followup monitoring/ trending (as applicable).

HSE Requirement/Statement:

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

Major challenges:

The incumbent will coordinate, prepare, and execute compliant stability programs for Routine, Initial and Special Study (including change control, clinical, nonclinical and intermediate studies) categories as required.
The incumbent will maintain technical and regulatory expertise with respect to the governance of Sanofi Pasteur Limited's stability operations/programs and lead initiatives for quality/process improvements.
The incumbent will represent the Stability Unit in collaboration (as necessary) with various departments within the Industrial Operations and ResearchtoLaunch Divisions. Decisions regarding the development or maintenance of stability studies are to be made based on established policies (e.g. Global Quality Directives), procedures (e.g., Standard Operating Procedures) and appropriate regulatory guidance.
Documentation practices must be of superior quality; projects must be undertaken in compliance with internal directives/policies, practices and procedures, as well as appropriate regulatory guidances and stability data analysis performed using sound scientific and regulatory knowledge.
Attention to detail, the ability to manage/handle multiple projects (and respect timelines), and effective coordination with other groups in support of longterm projects is requ