Deputy Director Quality Operations

Reference No. R2701087
Position Title: Deputy Director Quality Operations
Department: B200 Quality
Location: Toronto, Ontario
Sanofi Vaccines
Sanofi's global vaccines business unit partners with the public health, medical and scientific communities to improve access to life-protecting vaccines and increase vaccination coverage, while striving to develop new and improved vaccines to enhance health and well-being.
At Sanofi, we chase the miracles of science to improve people’s lives. We believe our cutting-edge science and manufacturing, fueled by data and digital technologies, have the potential to transform the practice of medicine, turning the impossible into possible for millions of people.
Position Summary:
This position is responsible for ensuring that all aspects of Process Validation activities for the B200 project, including Process Design, Process Engineering Batches, Process Development Batches, PPQ Batches are executed on time and in accordance with the Validation Master Plan, local and global requirements, and applicable regulations. In addition, this position will be responsible for developing a process for Continuous Process Verification post completion of PPQ batches.
As an integral part of the project quality team, this position has overall accountability for leading/participating in project workstreams, ensuring proper execution of process validation strategies as well as providing support and guidance for quality processes and procedures.
This role is expected to work independently and with a level of autonomy and authority in decision-making to ensure on-going compliance against approved documents and current Good Manufacturing Practices. This role is also expected to support the Deputy Director (Commissioning Qualification Validation) during the commissioning & qualification phase.
Key Responsibilities:
Process Validation Program Compliance (60%)

• Oversee all aspects of project validation activities in accordance with the Validation Master Plan and project deliverables, including but not limited to:
• Actively leads and/or engages in project work stream meetings, planning and scheduling meetings, and any related project requirements to ensure effective planning and execution of key Process Validation deliverables.
• Develop on-going monitoring program.
• Engineering, Development and PPQ Batches.
• Is responsible for managing process related validation activities related to Flu Manufacturing Process.
• Act as the accountable Subject Matter Expert (SME) for the project on all matters related to Flu Manufacturing Process.
• Participate in Design and execution of Cleaning Validation Activities.
• Provides direct coaching, training, and mentoring to Validation Manager(s) / direct reports. Develops and supports a high performing team environment that partners with key stakeholders and operates with strong process knowledge and risk-based decision making to ensure success of the project.
• Application of risk analysis and risk analysis tools.
• Maintain and report on key project deliverables related to Process Validation Compliance.
• Support the review/approval of validation protocols and final reports (Cleaning, Engineering, Development and PPQ Reports).

Support for Internal Compliance Activities (30%)

• Keeps updated on new internal validation standards and industry regulations and ensures project programs are aligned with best practices.
• Lead integration activities with site Quality Operations Validation Services team, ensuring alignment of validation approach and associated programs.
• Responsible for identifying opportunity for improvements to quality processes through the review and evaluation of quality metrics and recommending appropriate resolutions.
• Training Related Activities.
• Provides expertise and guidance with regards to regulatory requirements for manufacturing process systems, quality practices, and related validation/qualification activities.

Support for External Compliance Activities (10%)

• Responsible for supporting all relevant compliance inspections (e.g., Internal audits, Global Audits, Health Canada, FDA), and customer compliance inspection activities. This includes the 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.
• Build and maintain networks within Sanofi.

Context of the job/Major challenges:

• Influence key stakeholders and team members at all levels to ensure validation compliance and best practices are implemented and maintained for the project. From a leadership perspective, the role demands that the incumbent adapts to different leadership situations while coaching both junior and experienced team members.
• Perform and provide guidance to team members and key stakeholders on document review, non-conformance investigations, process change requests, quality improvement activities.
• The incumbent is expected to work independently and with a level of autonomy and authority in decision-making as a delegate to the Director as necessary to ensure on-going alignment with the Validation Master Plan, Project Quality Plan and adherence to the specific site policies and global policies related to validation.
• Develop and deliver high quality documentation within limited timeframes to align with current regulatory requirements and project commitments defined for the project.
• The incumbent is expected to provide guidance (or research issues if no guidance is readily available) for quality- or compliance-impacting decisions related to C&Q activities.

Dimensions/Scope:

• Support change initiatives and the implementation of process improvement initiatives.
• Maintain permanent inspection readiness and actively support regulatory inspections.
• The position requires that the incumbent interact with Operations, Manufacturing Technology and Engineering & Technical Services and Various Quality departments as a representative of B200 QO.
• The position may require a minimal amount of travel.
• Well versed with data integrity principles and ensuring that they are integrated into the business process to protect GxP data throughout its life cycle.
• Continuously monitor, analyze, and optimize the end-to-end process and anticipate and permanently resolve issues that may arise during the activities.
• This role will be part of the Quality team at Sanofi Toronto and will support Project Compliance and Quality initiatives.
• Foster a culture of compliance and strong health and safety performance.
• Support related investigations, ensuring compliance with internal standards and regulatory requirements.
• Review and approve the content of technical documentation (e.g. investigations, changes, SOPs and batch records, protocols and reports).
• Incumbent will also work in a global environment in development best practices and supporting the development of global Quality documents and standards supporting validation.
• The position generally operates both in an office and manufacturing/testing-type setting. The office environment requires intense concentration and visual examination of documents.
• Support the tracking of metrics and manage completion of objectives and projects.
• The position requires a particular vaccination for the areas of responsibility.
• This function is responsible for management of Technology Transfer from outside or within Sanofi sites and for the validation studies through the entire life cycle.
• Support Manufacturing Technology and Operations teams in identifying critical process steps, critical process parameters, critical quality attributes, critical material attributes and applicable process analytical technologies.

Key Requirements:

• Strong Quality and results oriented mindset.
• Good understanding of current and evolving regulatory requirements (FDA/EU/ICH/ISO).
• Ability to understand and respond to evolving regulatory and business environments.
• Technical writing, effective oral and written communication skills, and strong compliance mindset.
• Ability to anticipate evolutions due to internal and external factors.
• Previously held departmental supervisory and managerial positions.
• Strong presentation, communication, and organizational skills.
• Strong communication, interpersonal skills and teamwork are a must, as individual will be working on cross functional project teams which include members from various organizations within Sanofi. Good interpersonal and influencing skills are important for a candidate’s success in this role.
• Working knowledge of Production shop floor systems and processes. In-depth knowledge of the principle discipline - validation and biopharmaceutical industry compliance and data integrity assurance (i.e cGxPs, 21 CFR Part 11 & EU Annex 11, current industry standards and practices, and process/environmental engineering).
• Ability to effectively represent the organization on matters pertaining to policies, plans, and objectives.
• Ability to build, motivate, and inspire for effective teams, manage for high performance, develop personnel.
• Understand and deliver to meet patient and customer needs.
• Working knowledge and hands-on experience with production processing including automation, scientific writing, effective oral and written communication skills, and innovative thinking. Familiarity with strategic planning, balanced judgement, and risk analysis.
• Ability to set ambitious and realistic targets, build accountability. Set high standards, continuously improve.
• Conflict resolution and problem solving.
• Ability to be candid and direct, be comfortable with ambiguity and complexity.
• Look internally and externally for best practices and challenge the status quo.
• Minimum of Bachelor’s degree in Science/Engineering or a related field.
• 7-10 years of experience or combination thereof in a biopharmaceutical environment and in-depth knowledge of the biologic product license application process, and the associated regulatory requirements is mandatory.

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.
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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.