Manufacturing and Supply
Wo Wunder der Wissenschaft
für Patient*innen Realität werden

Reference No. R2797702

This position is responsible for managing the Annual Product Quality Review (APQR) process as required by regulations and Sanofi global quality guidelines. The position will collaborate with global Sanofi to support the transformation of the APQR process with the cutting-edge GenAIR tool powered by Generative Artificial Intelligence.  You'll revolutionize the way we create PQRs, making a significant impact on global quality standards.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities:

Annual Product Quality Review

• Collaborate Globally: Work with sites and Global Quality teams to gather essential information for APQR reports, ensuring seamless communication and collaboration.

• Innovate and Improve: Participate in Community of Practice meetings, share industry best practices, and drive continuous improvement initiatives, including the exciting GenAIR PQR tool.

• Lead and Coordinate: Oversee the preparation and approval of APQR reports for various products, ensuring timely distribution and coordination with input departments.

• Support and Enhance: Provide support for APQR-related requests, update documents, and implement improvements to enhance report effectiveness.

• Expert Representation: Serve as the Subject Matter Expert during audits and inspections, showcasing your expertise and leadership.

• Training and Compliance: Ensure training is up-to-date for cGMP activities, and maintain compliance with Health and Safety requirements.

• Data Management: Collect data throughout the year to prepare trend reports and performance metrics, driving informed decision-making.

• Change Control: Ensure timely completion of change controls and updates to site procedures, reflecting new or revised Global Quality Documents.

• Deviation and CAPA Management: Ensure related actions are completed by designated target dates, maintaining high standards of quality and compliance

HSE REQUIREMENT/STATEMENT

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

CONTEXT OF THE JOB/MAJOR CHALLENGES

• This position requires a strong understanding of Sanofi products and associated manufacturing and testing processes, in order to meet the required quality of the APQR reports

• Incumbent must possess effective communication skills to collaborate with various departments on site, in addition to Global and other Sanofi sites.

• Strong technical writing skills are needed in order to ensure accurate, clear and comprehensive documents are prepared.

• Incumbent must possess excellent time management skills in order to manage multiple reports at the same time and advanced planning to ensure sufficient time is allocated for the reports to be compiled, reviewed and approved.

DIMENSIONS/SCOPE

• Position is site-based.

• Accuracy and timeliness for preparation and review of APQR reports

• Interact successfully within the fast-paced production, testing and regulatory environments.

• Interact regularly with other sites and Global for activities relating to APQRs

• The incumbent must be able to communicate clearly (both written and verbal communication skills are required).

• The position is expected to make decisions and interpretations within broadly defined requirements at the site level.

• Position has a high degree of autonomy and is expected to make recommendations and decisions within defined requirements of the position.

About You

REQUIREMENTS

Education/Experience

• A minimum of 2-3 years of experience in the pharmaceutical or biologics industry with experience in GMP manufacturing (knowledge of testing, facilities, validation and utilities), quality systems (auditing, Deviations, CAPAs, Change Controls, Complaints), laboratory quality control, and process improvement 

• Knowledge of GMPs and regulatory requirements (Health Canada, EU, FDA and international)

• Experience with APQRs will be an asset.

Competencies

• Play to Win behaviours including Stretch, Take action, Act for patients and customers, Think Sanofi first

Key technical competencies and soft skills:

• The APQR Compliance Specialist is a detail oriented and results driven individual with exceptional technical writing skills.

• Possesses a strong understanding of biologics manufacturing and testing, as well as working knowledge of cGMPs.

• Ability to interpret/apply both national and international regulatory requirements

• Ability to understand role's impact and influencing skills.

• Knowledge and experience with various software/databases e.g. ERP, Quality Systems (Veeva and Phenix),  MS Office (Word, Outlook, Excel, Visio, PowerPoint, Teams, Sharepoint).

• Ability to effectively communicate verbally and in writing across various levels of the organization.

• Excellent organizational and interpersonal skills, as well as decision making ability.

• Able to collaborate effectively in teams, as well as work independently when necessary.

• Strong ability to prioritize and adapt to business and manufacturing needs are required.

• Ability to work strategically in a fast-paced environment and make balanced decisions related to quality.

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

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

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.

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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.

Les employés peuvent être admissibles à participer aux programmes d'avantages sociaux de l'entreprise. Des informations supplémentaires sur les avantages sociaux peuvent être trouvées ici.