Manager, Operational Quality - Vaccines (LXO037)

Manager, Operational Quality - Vaccines (LXO037)

31 dic
|
Sanofi
|
Villanueva de la Cañada

31 dic

Sanofi

Villanueva de la Cañada

Title :

Manager, Operational Quality - Vaccines Location :

Toronto, Canada

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.

This position requires strong collaboration and communication with key responsible Partners in the APT, and with other stakeholders across the organization, including within OQ-SA,

Validation Services, Product Quality, QC and Quality Systems, MTech and ETS.

Key Accountabilities

Provides coaching and leadership to shopfloor staff, assuring that processes are executed effectively, compliantly and thereby enabling and promoting a Quality culture. Partners with production and operates with strong process knowledge and risk-based decision making, required on the shopfloor to support cGMP compliance. Responsible for timely and thorough deviation investigations, guiding the investigation team as required throughout the investigation process (problem definition, scope, investigation strategy, RCA, CAPAs) and ensures that batch decisions are compliance and science-based, and supported by strong data driven justification. Ensures timely review and approval of deviations, SOPs, CAPAs, ERs and other GxP documents such as Master Batch Production Records, operational log books, sterilization and depyrogenation records, work orders, worksheets, maintenance task lists, change control assessments and approvals, and protocols/ reports that are within the scope or delegated.

Participates as QO Representative at various committees and boards such as:

Sanofi Pasteur Change Control Board, Deviation Review Board, +QDCI, FFast, etc. Participates in self-inspections, periodic internal reviews/audits to ensure compliance procedures are followed, and participates in external audits/inspections. Identifies and mitigates risks, and leads Shopfloor Quality improvement within the APT and more broadly as applicable. Ensures alignment to Global and new Regulatory requirements, participating in gap remediations, compliance and Site Projects as required. Support the OQ Deputy Director (as required) in the following (but not limited to) assessing and approving Process at Risk (PAR) forms, Provision batches in the eBAR for financial month end.

Key accountabilities

Provides coaching and leadership to shopfloor staff, assuring that processes are executed effectively, compliantly and thereby enabling and promoting a Quality culture.

Partners with production and operates with strong process knowledge and risk-based decision making, required on the shopfloor to support cGMP compliance.

Responsible for timely and thorough deviation investigations, guiding the investigation team as required throughout the investigation process (problem definition, scope, investigation strategy, RCA, CAPAs) and ensures that batch decisions are compliance and science-based, and supported by strong data driven justification.

Ensures timely review and approval of deviations, SOPs, CAPAs, ERs and other GxP documents such as Master Batch Production Records, operational log books, sterilization and depyrogenation records, work orders, worksheets, maintenance task lists, change control assessments and approvals, and protocols/ reports that are within the scope or delegated.

Participates as QO Representative at various committees and boards such as:

Sanofi Pasteur Change Control Board, Deviation Review Board, +QDCI, FFast, etc.

Participates in self-inspections, periodic internal reviews/audits to ensure compliance procedures are followed, and participates in external audits/inspections.

Identifies and mitigates risks, and leads Shopfloor Quality improvement within the APT and more broadly as applicable.

Ensures alignment to Global and new Regulatory requirements, participating in gap remediations, compliance and Site Projects as required.

Support the OQ Deputy Director (as required) in the following (but not limited to) assessing and approving Process at Risk (PAR) forms, Provision batches in the eBAR for financial month end.

Education and experience

Specific degree, duration of experience (Required to hold the job):

Bachelor of Science specializing in Microbiology, Biochemistry, Immunology or Pharmacology with 5 or more years of relevant experience in a pharmaceutical or biological manufacturing environment.

Experience interacting with regulatory agencies and health authority inspections is required.

Key technical competencies and soft skills

Strong leadership and management capability

Excellent knowledge of cGMPs, compliance trends and vast amount of experience with inspections/audits

Excellent problem solving (root cause analysis), investigation skills

Strong influencer and communicator

Solid experience with continuous improvement methodologies and risk-based approaches

Sanofi is an equal opportunity employer committed to diversity and inclusion. Our goal is to a ttract, 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.

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