Validation Manager, B100

Job type: Full-Time
Accepting BioReady™: Yes
Category: General Management, Operations and Administration
Employer: Sanofi
Location: Toronto, ON
Posted: March 16, 2023
Closes: April 16, 2023

Job description:

Reference No. R2675046

Department: B100 Validation

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 purpose of this position is to manage and ensure validation initiatives supporting B100 start-up, licensure and lifecycle management are performed in accordance with cGxP standards, regulatory and internal requirements. This purpose is achieved through the management and execution of a project validation master plan, collaboration with a team of cross-functional professionals, and the review and approval of validation protocols, resultant reports and associated documents. Validation status is maintained through the use of a change control process identifying appropriate revalidation when and where required. This role is primarily responsible to ensure quality and compliance for all project validation activities across the various project workstreams under CQV, Process Validation, and Cleaning Validation.

Key Responsibilities:

Management of Qualification and Validation

• Provide Quality Oversight for qualification and validation of all manufacturing process equipment, single use systems, utilities, facilities, manufacturing processes and associated cleaning, and ITS systems in support of B100 start-up, regulatory licensure and lifecycle management. Ensures and verifies compliance to Regulatory and Corporate validation standards and policies. Actively participates, leads, and provides quality leadership on validation strategies. This includes the review and approval validation deliverables (i.e. URS, specification documents, risk assessment, test strategies, protocols, reports, validation plans, SOPs, periodic reviews) in accordance with internal and regulatory policies.

• Responsible for working with user/system owner to perform validation(s) as per designated validation protocols and to critically evaluate the results to determine if these adequately meet the acceptance criteria. Describe the methods required, provide the acceptance criteria and include a rationale for these choices. Update and revise project, and where applicable, company policy/procedures related to validation as required. Moreover, support the investigation and closure of non-conformances resulting from validation/qualification studies linked to routine revalidations and other validation activities. Also, approve follow-up on, and close corrective and preventative actions (CAPA) and change controls initiated by the respective project workstreams.

Validation Resource

• Provide expertise and guidance with regards to regulatory requirements for validation/qualification activities including quality best practices, validation strategies, procedures, and related activities. Critically evaluate the results to determine if the analysis is valid with sound scientific justification, the outcome adequately meet the acceptance criteria, and the validation is in compliance with the Regulatory and Corporate validation standards and policies.

• Responsible for providing Quality Validation responsibility to support the review and approvals of change controls and Nonconformance’s. This involves working closely with project key stakeholders, workstream leaders, and support departments to ensure that the appropriate expertise is engaged and that closure timelines are achieved. Support activities to support successful integration of B100 to site.

Collaboration on Local & Global Quality Initiatives

• Keeps updated on new rules and industry regulations and ensures alignment of B100 project activities with identified best practices. Responsible for identifying opportunity for improvements to quality processes through the review and evaluation of quality metrics and recommending appropriate resolutions.

Support for External Compliance Activities

• Provide subject matter expertise during External and Internal Regulatory Inspections defending the programs and the individual validated equipment/systems and providing timely and technically completed responses to audit observations linked to internal, corporate and Health Authority inspections. This includes responsibility of pre-inspection preparations, coordination of activities, participation in post-inspection responses, follow-ups and the assurance of inspection reports to appropriate management personnel.

Training and Interactions

• Responsible for training new and/or existing colleagues on specific procedures/processes when identified and/or designated by Department Head. Ensures all training records and other validation documentation updated according to corporate policies.

• Responsible for all local communication reports and updates (e.g., keeping direct supervisor appraised of local quality issues, completing monthly reports, completing metrics worksheets, etc.). Ensure that Department Metrics are clearly recorded such that activities can be measured. Responsible for communicating and collaborating on a timely basis with the respective project team representative +/or back-up to ensure continuous and consistent service.

• Responsible for interacting with project key stakeholders and team members as required.

Major Challenges:

• This position requires a strong understanding of quality, and team leadership attributes as the incumbent will lead/work with a team of individuals/professionals from various Industrial Operations /or QO departments who will execute much of the validation to ensure the necessary planning, training, design and approvals, and resultant data are in line with company standard and regulatory requirement. An ability to negotiate and communicate with people in a positive manner while identifying, discussing and rectifying problems is a requirement of the position. The nature of these relationships includes the range from senior management staff to direct line employees.

• A key challenge for the role will be to influence stakeholders, service providers and team members in order to maintain priority for these activities. Furthermore, the teams must develop and deliver high quality documentation and reports within limited timeframes in order to align with regulatory or project commitments defined at site and/or global level. The position requires the incumbent to constantly remain abreast of a changing regulatory environment and new approaches to validation design/approaches.

• Strong, effective interpersonal and communication skills are required for interaction with project key stakeholders, team members and supporting departments. These interactions are key in order to obtain and/or transfer services, samples, equipment and materials, and to communicate validation needs, negotiate transfer of tests, and present validation approaches or specific recommendations.

• Good planning, judgment and focus are required to ensure realistic resource needs and project schedules are in place, and to drive on-time completion of deliverables.

• The incumbent will interact with other internal auditors, and other site auditors, and corporate (or third party) auditors during audits.

• The incumbent must be able to defend programs and provide professional and technical support during corporate and external regulatory inspections in a competent and convincing manner.

• The ability to facilitate and prioritize the issues identified with validation of process development processes in a timely fashion requires flexibility, constructive and/or innovative thinking for resolution and management of the issues.


• Role is responsible for validation activities to support start-up, licensure, and lifecycle management of B100. Validation is a subject area which is reviewed by inspectors both external in internal during inspections and can be the source of critical or major regulatory observations.

• The position generally operates both in an office and manufacturing/testing-type setting. The office environment requires intense concentration and visual examination of documents.

• The position may require a particular vaccination for the areas of responsibility.

• The position may require a minimal amount of travel.

• The position requires that the incumbent interact with Operations (Production, Technical Services, Quality Control, manufacturing Technology) colleagues as a representative of QA both within Project Teams, and on a consultant/expert basis.

• The position requires processing protocols and summary reports. Volume will depend on the nature of the validations.

• The number of change control requests processed will depend on the nature of the revalidations. The incumbent will be expected to asset/contribute the categorization, planning, verification and approval of each in collaboration with the responsible department to ensure timely closure.

• Incumbent may be involved in the assessment of key capital procurements to ensure variability.

• The position comprises 90 % standard office time, plus 10 % in the field. Hazards involve exposure with protective equipment to pathogenic organisms and toxic chemicals, mutagens, and biological toxins. Current immunization is required for the position. Domestic and international travel (e.g., scientific meetings) is an occasional requirement for up to 1 week per year.

Key Requirements:

A degree in Chemical Engineering, Biology, Biochemistry, Life Sciences or a related field, combined with 5 to 7 years of relevant work experience within the biopharmaceutical industry. Related to qualification and validation experience in manufacturing, preferably biological industry or equivalent.

Desirable Certifications:

• ISO Certified Auditor.

• Quality System certification training from a recognized institution are all assets.

• In-depth knowledge of the principle discipline- validation and biopharmaceutical industry compliance (i.e cGXPs, current industry standards and practices, and process/environmental engineering).

• Working knowledge of Microbiology, Biochemistry, Chemical Engineering, Fermentation, Cell and Viral Culture, and Formulation & Stability. • In depth knowledge of experimental work and data analysis.

• Working knowledge and hands-on experience with computer and statistical skills, scientific writing, supervision/management of teams and people (and their development), effective oral and written communication skills, and innovative thinking.

• Familiarity with strategic planning, balanced judgment and risk analysis.

• Strong communication and influencing skills, problem solving, regulatory and compliance trends, strong leadership and management capability.

Pursue Progress.

Discover Extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

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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.


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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