Job Description

Job title: QA Operations Lead

• Location: Singapore
• % Remote working and % of travel expected: To follow current arrangement for EVF Tuas: 40% remote (subject to change), possibility of 1 travel between 2023 to 2024.
• Job type: Permanent, Full time

Mission
Vaccines Industrial Affaires (VIA) is preparing its future through an ambitious program named Evolutive Facility (EVF). The EVF Project is at the cornerstone of Sanofi Pasteur strategy as it aims at creating a new manufacturing concept consisting of a new generation of evolutive multi-product facilities, modular, adaptable and agile, leveraging new disruptive technologies, to better address vaccine business challenges. Digital will be one of the key topics to help EVF to reach its ambition. On top of it, VIA is also embarked with the ambition to leapfrog the competition through a digital acceleration program with the following vision: \xe2\x80\x9cVIA will fully integrate Digital capabilities & culture within its operations to boost business growth and profitability in 2025+\xe2\x80\x9d.

In this context, we are looking for QA Operations Lead for our new site based in Singapore.

Key Accountabilities
The mission described below, must be exercised in compliance with health, safety and environment of the site rules.

The QA Operations Lead will be responsible to partner with GMP operations team to provide quality oversight and advice for Quality on-the-floor and operations support to ensure the EVF Singapore GMP quality operations meets Sanofi global quality standard requirements and fulfil the applicable regulatory expectations. Experienced in solving complex problems, and strong understanding of cGMP operations and well-versed in multiple quality systems (including exception management, change controls, deviations/CAPAs and document management system).

The incumbent will partner closely with operational teams (e.g. manufacturing, facilities, quality control and technical units) to ensure quality, safety, reliability, efficiencies to support EVF Singapore GMP manufacturing operations.

• Responsible to shape, influence and provide quality advice to GMP operational teams to ensure compliance, reliability and efficiencies.
• Responsible to provide direct QA oversight for all GMP operations (including on-the-floor quality oversight, raw materials release, deviations, change controls and CAPAs) at EVF Singapore manufacturing facility.
• Accountable to ensure all quality related operational procedures, infrastructures are successfully implemented to support EVF Singapore site operational and inspection readiness and success.
• Coach and mentor cross functional team members with the goal to establish an engrained quality culture across the organization.
• Key quality representative to resolve complex issues, and participate in root cause investigations, leveraging in root cause analysis tools and methodologies.
• Lead and support the site driven QA continuous improvement initiatives/activities during the routine operational phase.
• Strategizing, reviewing and approving playbooks for direct manufacturing related topics to ensure the success of regulatory inspections and site audits.
• Lead and participate in regulatory inspections and interact directly with regulatory inspectors (as applicable).
• Escalate significant quality issues to Quality management in a timely manner.
• Lead and support QA Operations related trainings and coaching for the Quality organization.
• A key EVF SG Project Quality key member to partner and collaborate closely with cross functional teams to achieve the EVF SG site operational goals/objectives.
• Contribute to reach the EVF quality manufacturing 4.0 ambition through a Quality plan.

Education and experience

• Bachelor\xe2\x80\x99s or Master\xe2\x80\x99s Degree in Sciences, engineering or other related technical field.
• Minimum of 10-12 years of relevant experiences preferably in Manufacturing, Validation, Quality in the pharmaceutical or biotechnology industry (preferably in vaccines and/or biologics).
• Minimum of 5 years of managerial experiences to lead a team effectively in a matrix environment.

Key technical competencies and soft skills:

• Manufacturing 4.0 mindset (such as Agile methodology)
• Knowledge of regulations and standards of the pharmaceutical industry, Global Quality policies and Data Integrity Requirements.
• Solid manufacturing process technical knowledge.
• Broad and in-depth understanding of QA Operations (from an end-to-end perspectives).
• Strong interpersonal relationships in order to establish the partnerships necessary for the development of an engrained Quality culture and the correct execution in transverse.
• Discipline and assertiveness in the decision-making and execution of digital manufacturing strategy and execution.
• Familiarity with electronic batch record (MES) and lot disposition process using SAP system.
• Strong leadership skills and demonstrated solid success to lead QA Operations related activities.
• Proficient in QMS and Quality Risk Management Principles.
• Excellent verbal and written communication skills; effective communication and presentation skills across different levels of the organization, including senior management and execution levels.
• Experienced in facility start-ups will be advantageous
• Good understanding of risk-based decision framework
• Experience in working internationally and cross-functionally
• Familiar with Digital 4.0 concepts and potential applications in Quality

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.