Validation Specialist

Job Responsibility:

Reference No. R2796200

Position Title: Validation Specialist

Department: Computerized System Validation

Duration: Fixed Term Contract End Date: November 20, 2028

Location: Toronto, Ontario

About the Job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

The purpose of this position is to Provide guidance with regards to regulatory requirements and also act as a sponsor for Quality practices for computerized systems. Provides decisions, guidance, and recommendations pertaining to computerized systems, strategies, procedures, and validation activities. Provide interpretations of Regulatory guidelines and regulations for implementation of computerized systems. Participates, leads and or executes validation strategies as well as provides support for the quality processes and procedures. This role is primarily responsible to ensure the validated state of the operations (Manufacturing and Quality Control) and includes Quality Oversight of protocol development and execution, final approvals of documentation.

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:

Management of Validation - 70%

• Validate and manage computerized systems deployed to the site and local site computerized systems

• Provide validation expertise and guidance to project teams for computerized systems using a risk-based approach. Coordinates the risk assessment of computerized systems and ensured execution of validation activities. Support operation & maintenance phase of computerized systems to ensure computerized systems are maintained in validated state. Provides leadership and guidance in regard to computerized systems at the Toronto site.

• Provide guidance and recommendations into validation strategies for implementation of computerized systems by through company policies, and procedures as well as providing input to individual projects and activities. The output of these activities includes approved system validation and test plans that provide a blueprint on how computerized systems should be implemented and or validated to meet regulatory requirements and business expectations. Deliver testing strategies that enhance the overall quality of projects and systems.

• Provide input, comments, and recommendations or developing documents relating to computerized system validation and overall quality processes (including SOPs, specifications, protocols, and reports) by detailed review or approval of these documents in relation to regulatory requirements and company policies and procedures. Using established Regulatory and GxP background to guide and or participate in developing quality and validation procedures and processes. The output of these activities includes computerized system documentation that meets regulatory, company, and department compliance and validation requirements. (15%)

• Lead and or manage computerized systems validation and quality personnel by regularly providing direction, input and guidance on their activities for prioritization and to maximize support to projects throughout the company. The output of this activity is to provide efficient, prioritized support to project teams involved in computerized systems validation activities. (15%)

• Interface with consultants on Sanofi Pasteur expectations and requirements relating to computerized validation activities by regular meetings and review of deliverables related to computerized systems validation activities. Output includes computerized systems validation documents and activities delivered by consultants that will meet Sanofi Pasteur's requirements and expectations in order to optimize computerized systems validation activities and reduce project costs. (10%)

Validation Resource 10%

• Provide leadership and guidance with regards to regulatory requirements and also act as a sponsor for Quality practices. Provides decisions, guidance, and recommendations pertaining to computerized systems, strategies, procedures, and validation activities. Provide interpretations of regulatory guidelines and regulations for implementation for computerized systems. Participates, leads and or executes validation strategies as well as provides support for the quality processes and procedures.

• Participate and support on supplier audit to ensure that third party suppliers and / or service providers have a quality system in place and can provide quality products and / or services in adequacy with Sanofi business and quality requirements. Development of procedures and policies related to computerized systems, electronic record keeping, or using electronic signatures by authoring or providing input to written, approved procedures and policies relating to computerized system validation activities or deliverables. The output of this process includes procedures that provide clear guidance and instructions to personnel involved in computerized systems validation activities that will minimize the cost of computerized system implementation.

Collaboration on Local & Global Quality Initiatives 10%

• As required, represent Quality Operations on project team and/or sub-teams and/or project working groups to provide direction on validation issues with respect to compliance as defined by manager in support of new and existing validation projects. Where needed, participates with Change Control Committee in the review of CCR according to Sanofi Pasteur policies. Works with other Quality Departments at the site on setting initiatives and action plans and implementing resolutions.

• 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 through the review and evaluation of quality metrics and recommending appropriate resolutions. Where required participates on local and global Quality initiatives impacting quality systems to ensure harmonization of processes and initiatives including those focusing on improving Quality Support.

• Build and maintain networks within Sanofi and as required participates in on-going global quality initiatives via Centre of Excellence (CoE) and Subject matter expert (SME) networks.

Support for External Compliance Inspection Activities 10%

• Interface with personnel in relation to regulatory interpretation of GxP and Non-GxP requirements as well as interface with personnel from other Sanofi sites or auditors / inspectors in relation to computerized systems validation and other quality activities to assure consistency, coordination and standardization of policies, procedures, and practices by participation and providing input at meetings and review of documentation pertaining to global projects. Output includes more standardized and coordinated policies and procedures relating to computerized system validation and other quality activities and a common approach during agency or third-party inspections.

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

Training and Interactions 10%

• Provide training on activities, procedures, and requirements pertaining to computerized systems validation by providing overall training courses related to computerized system validation or regulatory interpretation as well as training to personnel involved in individual projects. Interact with management and other personnel to provide awareness and education on requirements to computerized systems validation and other quality activities. The output of these activities is providing trained personnel that will clearly understand their responsibilities as they pertain to computerized system validation, implementation, operation and maintenance. The output of this activity also includes obtaining critical management support and approval on implementation of compliance, quality, and computerized systems validation activities.

• 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 other M&S departments as required (FFast and QCDI boards).

Perform Computerized System Periodic Review 10%

• Manage and lead GxP computerized systems periodic review program for Digital and Site systems.

• Establish site system periodic review plan with periodic review schedule by following the relevant governance SOPs on system periodic review.

• Communicate and coordinate with system and process owners, system supporting functions to ensure that system periodic review plan is reviewed, approved and ready for execution.

• Coordinate the execution of the periodic review plan to ensure that the periodic review schedule is completed as planned.

• Develop the periodic review report to provide evidence that an effective review has taken place, with necessary corrective actions and plans in place as needed.

• Coordinate and follow up on closure of corrective actions and plans as needed.

• Update and maintain site computerized system inventory list and ensure it is current, accurate and complete to reflect the system status.

• Participate and provide audit and inspection support and coordination for system validation related

CONTEXT OF THE JOB/MAJOR CHALLENGES

• Develop validation, quality, and implementation strategies pertaining to critical and complex computerized systems and conveying that information to project team members. This activity occurs regularly for all computerized systems validation projects and in support of financial business systems. Information to resolve problems in typically obtained by relating previous experiences, feedback from computerized systems validation colleagues at other sites, regulatory guidance, and discussion with project team members. Solutions are critically and objectively evaluated to determine pros and cons in relation to alternative solutions.

• Ensuring all computerized systems are developed and maintained to the highest standards of quality & compliance. Ensure proper understanding of requirements and deliverables are part of the project methodology

• Prioritize limited resources to support computerized systems validation, quality, and compliance initiatives and activities in relation to each other. Prioritization occurs on a daily basis and requires feedback and input from internal personnel as well as other contacts within the company. Solutions are determined based upon input and evaluation of critically of activities to business needs and project schedules.

• Evaluation of regulatory, quality, and compliance risks in relation to computerized systems validation and other activities to determine the most appropriate decisions and strategies to the company. Activity occurs daily and information obtained is based upon previous experience and knowledge of regulatory requirements and expectations. Possible solutions are determined based upon evaluation of risk and feedback obtained from management on best approaches to mitigate risk. Lead contact and interface during regulatory inspections or external audits as well as developing a common and clear response to inspection or audit observations.

• Directly or indirectly supervises technical or professional staff who exercises considerable latitude or independence in their own assignments. Trains, appraises and has some involvement in development of employees. Make recommendations on hiring and promotion

• Act as delegate for SQO Director as needed.

DIMENSIONS/SCOPE

• Role is responsible for site validation which is key to the existing and new product registrations. 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 requires that the incumbent interact with Operations (Production, Technical Services, Quality Control, manufacturing Technology) colleagues as a representative of QO both within Project Teams, and on a consultant/expert basis.

• The position requires processing protocols and summary reports, depends 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 will also work in a global environment in development test practices and supporting the development of global Quality documents and standards supporting validation.

• 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.

About You

REQUIREMENTS

Education/Certifications

• Bachelor's degree in engineering or science

• 5+ years of relevant work experience within the biopharmaceutical industry. Related to qualification and validation experience in manufacturing, preferably biological industry or equivalent preferred.

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

Required Qualifications:

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

• In depth knowledge of experimental work and data analysis.

Additional Preferred Qualifications:

• 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.

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.

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.

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.