Sanofi Group Manager, R&D SQO Validation in Toronto, Ontario

Summary:

The purpose of this position is to ensure that all validation initiatives involving facilities, utilities, equipment and computerized systems supporting Research & Development GMP activities are in compliance with Regulatory and Global Quality policies and standards. This is achieved through active participation on Engineering, ITS and validation project teams. This involves the assessment of system vendors and their equipment, ensuring 21CFR Part 11/Annex 11 compliance, review and approval of test protocols, specifications, facility/P&ID drawings and reports. Validation status is then maintained through participation in the change control process (identifying appropriate revalidation where appropriate). Providing technical quality support to various user groups including IS, purchasing and Global/Site Engineering and Maintenance. Collaboration with the various groups is essential to the success of achieving and maintaining compliant facilities, utilities, equipment and computerized systems.

Key accountabilities:

Computerized / Non-Computerized Equipment, Process, Facility and Utility Validation

  • Represent Quality on capital projects, understanding of facility/utility drawings and impact to GMP operations

  • Provide quality support to the evaluation of: software applications associated with computerized systems

  • Assess quality risk associated with changes to: equipment, facilities, utilities and processes for clinical manufacturing

  • Provide technical support to the design and configuration of various systems

  • Ensure validation is in compliance with 21 CFR part 11 and Annex 11 (where applicable)

  • Provide final review and approval of all system/facility validation, design and execution documentation

  • Advise on test requirements, scope, and acceptance criteria as per project deliverables

  • Ensure that the methodology used in qualification testing will thoroughly test and challenge applicable system/facility

  • Review and approve development documentation for GMP compliance, business risk, and consistency

  • Provide and monitor non-conformance results during the validation studies to determine acceptable remediation/corrective actions

  • Lead/manage/participate in global alignment projects for validation and compliance

Project Team representation

  • Represent Quality Operations on key company projects to ensure project deliverables are attained from a validation and quality perspective

  • Coordinate with project team on Commissioning and Qualification activities as per the designated validation plan and protocols

  • Provide Quality engineering support in the selection of vendors, participate in assessment of system design/redesign

  • 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

Collaboration on Local & Global Quality Initiatives

  • Participates in global SQO networks (such as FUE – Facilities, Utilities, Equipment)

  • 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

  • Participates in global R&D SQO initiatives impacting quality systems to ensure harmonization of

  • Participates in local customer service initiatives including those focusing on improving R&D SQO support

Audits

  • Perform Vendors’ and in-house audits (approximately 10 - 15 % Travelling)

  • Ensure all required documentation to be provided by vendor/consultant will allow Sanofi Pasteur Canada to be self - reliant and compliant

Training & Interactions

  • Develop and maintain site policies and procedures that describe validation initiatives that are aligned to regulatory requirements and global Quality and Industry standards. Update and/or provide training to users on validation policies and procedures

  • Develop documentation consists of specifications, protocols, plans, training material and SOPs for systems including stand alone and custom built systems (ie. Automated systems, Analytical tests equipment including macros for calculations methods)

Responsibilities:

  • Incumbent must remain current of changing regulatory environment and new approaches to validation, commissioning & qualification design/approaches

  • The incumbent must provide to users, Site/Global engineering and purchasing; quality and technical support related to the evaluation and purchase of equipment (computerized/non-computerized) and business processes

  • Incumbent must understand computer validation methodologies such as to define the extent of validation based in intended use and/or risk assessment

  • Incumbent must understand the engineering procurement and design methodologies

  • Incumbent must collaborate closely with User groups including Site/Global engineering, maintenance and IS to ensure compliant validation strategies and ensure systems remain compliant throughout their lifecycle

  • 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 incumbent must be familiar with changing regulatory environments in computer validation (i.e. 21 CFR Part 11, Annex 11, ASTM 2500 Verification, Key Industry Standards in Automation)

REQUIREMENTS

Education

  • Minimum, B.Sc. or Equivalent in Computer and/or Engineering Sciences.

  • Training in commissioning/qualification and validation is an asset.

  • Certifications in Project Management and/or Six Sigma is an asset

  • Professional Engineer designation is an asset

  • Ability to read/write French is a plus

Industry Experience

  • Five to seven years related job experience required

  • Experience of manufacturing environments (equipment/facilities/utilities) for biologics

  • Experience/knowledge in validation design/approach and System Development Life Cycle (SDLC)

  • Experience in commissioning and qualification of equipment (computerized/non-computerized) and facilities

  • Experience in project management (as it relates to commissioning/qualification deliverables)

  • Evaluate System Suitability based on Functional and Design Specifications

  • Selection of Vendor and perform audits

  • Read configuration, network and connection diagrams

  • Read and understand engineering P&ID diagrams

  • Excellent problem solving, report writing and communication skills

  • Good knowledge of Quality Systems/Practices

  • Practical knowledge of vaccine manufacturing.

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.

Sanofi, Empowering Life

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.

Sanofi, Empowering Life