Batch review specialist - #231214

R2860560 Batch review specialist

Location: Toronto, ON

Duration: 1 year

About the job

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.

Our Team/ Overview:

The Quality Assurance team serves as a critical guardian of patient safety and product excellence through rigorous GMP record review and batch release activities, while fostering a culture of quality ownership and continuous improvement across operations. Through systematic oversight and shopfloor expertise, we proactively identify and mitigate quality risks, maintain robust quality systems, and ensure full regulatory compliance. Our collaborative partnerships across all functions embed quality principles into every aspect of operations, enabling the timely delivery of high-quality products to patients while upholding the highest standards of operational excellence.

About Sanofi

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

Main Responsibilities:

• Ensuring that activities in his/her scope are conducted in compliance with applicable regulatory requirements

• Reviewing batch records and associated documentation

• Ensuring all conditional batch release activities comply with Good Manufacturing Practices (GMP)

• Fostering a culture of quality and continuous improvement across the organization

• Participating in internal and external audits and regulatory inspections providing support and documentation

Key Roles (D,A,I):

• Prioritize quality and compliance objectives (D)

• Approve a batch record if it is correctly completed and meets the quality requirement for one lot (D)

• Check whether all practices are done according to quality requirement; if not, assure that a deviation is opened and reported in the batch record (D)

• Review documentation for batch disposition (A)

• Advise on initiatives to promote a quality-focused culture (A)

• Advise on how to present a topic and answer specific questions (A)

Additional Accountabilities:

• Ensure timely review, follow-up and approval of executed batch records and as

• Ensure SAP activities linked to executed BPRs are complete and accurate.

• Escalate to Management on quality events detected; propose resolutions in partnership with Production and QA specialists.

• Partner with Production to ensure cycle times are met and implement continuous improvements as required.

• Responsible for the execution and timely completion of Quality System commitments (deviations, CAPAs, change controls, audit and regulatory) as applicable.

• Lead/ execute projects that improve safety, quality, delivery, cost, involvement and strategic priorities.

• Any other duties that may arise as required.

Disclaimer

The above information was designed to indicate the general nature and level of work performed by employees with this job description. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job. Requirements are subject to possible modification to reasonably accommodate qualified individuals with disabilities. This document does not create an employment contract, implied or otherwise, other than an “at will” employment relationship.

About You

• Bachelor of Science or Engineering degree with 3+ years of relevant experience in Quality Operations from a Pharmaceutical or Biologics Manufacturing facility.

• Use of Technical/ Manager Expertise.

• Impact and Influence.

• Balanced Judgment/Risk Analysis.

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 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, Data Subject Rights Webform. The Data Subject Rights Webform can also be used to request 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.

#GD-SP
#LI-SP

#LI-Onsite

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.

Toute compensation sera déterminée en fonction de l'expérience démontrée. 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.