Manager Batch Release R&D Site Quality Operations
Job Overview
Job title: Manager Batch Release R&D Site Quality Operations
Job description: Title: Manager Batch Release R&D Site Quality Operations
Reference No. R2627100
Location: Toronto, Canada
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
The Manager Batch Release R&D Site Quality Operations (SQO) releases compliant batches of clinical trial material (CTM), vaccines, manufactured in accordance with cGMP standards, and regulatory and internal Sanofi requirements. This purpose is achieved through the review of the completed batch production records, process specific records, analytical records, environmental monitoring data, and deviation/change control related forms. It also requires investigation, evaluation, recommendation, tracking and trending of all product issues according to regulatory and internal procedures.
KEY ACCOUNTABILITIES
Review & Release of CTM Manufacturing & Analytical Testing Records:
Responsible for the timely overall review and approval of the manufacturing records. This includes the following: review of the executed batch production records (BPR), review of process specific records for conformance, review of analytical records (and associated Certificates of Analysis), review of environmental monitoring data as required prior to batch release, and the review of deviation/change control documents to verify acceptability of issues and their resolutions.
Responsible for prioritized release of all clinical batches (and associated steps) produced either in-house or made on contract according to regulatory and internal Sanofi requirements as well as in accordance to the company strategic objectives. The release activity includes the verification of all associated reviews to ensure consistency of the overall batch record that all previous manufacturing steps including raw materials, media and reagents have been released prior to release of the batch and the verification that any associated deviations and/or other batch discrepancies have been resolved prior to release and approval of contractors for pharmaceutical manufacturing.
Responsible for providing input for the compilation and subsequent approval of the Product Specification File (PSF).
The incumbent is responsible for managing the quality and compliance risks associated with the review and release of product produced in clinical trial material (CTM) manufacturing in accordance with cGMP standards, and regulatory and internal requirements.
Responsible for assigning expiry dates to clinical batches
Responsible for carrying out all required SAP transactions for product review and release
Responsible for assisting in the compilation of an inventory list of all batches and their disposition status as required.
Responsible for ensuring that site archiving rules are followed for batch records.
Responsible for ensuring that clinical batch release procedures are in place and maintained (timely revised when required) according to regulatory and Sanofi requirements.
Responsible for evaluating and reporting Quality Metrics related to batch release
Responsible for addressing clinical trial complaints for vaccine projects
Responsible for ensuring appropriate actions are taken by R&D during a recall situation. In the absence of recall, responsible for coordinating periodic mock recalls as per Sanofi requirements.
Responsible for representing R&D SQO on assigned project team and/or sub-teams and/or project working groups in order to provide quality expertise, direction on quality issues and regulatory compliance and for executing actions.
Keeps updated on new rules and industry regulations, and to define and align internal quality systems with best practices. Responsible for identifying opportunity for improvements to quality processes.
Provides professional support during internal and external inspections and audits in a competent and convincing manner.
Support new technologies implementation in R&D (as required).
REQUIREMENTS
Familiarity with aseptic manufacturing processes, filling operations, cleaning, sanitization, sterilization techniques, aseptic techniques, cleanroom management and aseptic process control and all the relevant tests is fundamental in performing the job.
A strong understanding of quality, and teamwork attributes as the incumbent will associate with a team of individuals/professionals from various R&D and/or Quality departments to resolve problems or implement quality systems. An ability to negotiate and communicate with people in a positive manner while identifying, discussing and rectifying problems is a requirement of the position.
As these activities have an impact on multiple work units, this position must ensure the availability of product for further manufacturing, and/or release to clinical trials, by the timely and accurate review of specific batch documents. Improper release of product to clinical trials could result in jeopardy of the safety of clinical research subjects.
The ability to facilitate and prioritize the issues identified with the review and release of product production CTM manufacturing in a timely fashion requires flexibility, constructive and/or innovative thinking to resolve and manage the process.
Works within the policies, procedures and regulations as required by the regulatory agencies, Sanofi and under the Occupational Health and Safety Act.
Required Qualifications:
(Minimum) Bachelor of Science Degree in a relevant discipline (e.g. Biology, Microbiology, Biochemistry)
6-10 years related quality experience in the pharmaceutical industry
Strong technical background, expertise in vaccines or biologics with demonstrated knowledge of quality practices
Strong skills in decision making, problem solving and critical thinking
Strong written and communication skills are critical to ensure teams are guided through cGMP (Quality System) requirements
Excellent knowledge of the GMPs for US, Canada and Europe
Ability to work in group setting and independently; ability to adjust to changing priorities
Strong customer and results orientation
Certifications (not mandatory but would be considered assets):
Quality System certification training from a recognized institution is an asset.
Qualified Person
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.
Thank you in advance for your interest.
Only those candidates selected for interviews will be contacted.
Sanofi, Empowering Life
#GD-SP #LI-SP
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.
Company: Sanofi
Expected salary:
Location: Toronto, ON
Job date: Sat, 01 Jan 2022 04:52:17 GMT
Job Source: Careerjet.ca